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Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

This study is currently recruiting participants.
Verified by Vitatron France, September 2005

Sponsored by: Vitatron France
Information provided by: Vitatron France
ClinicalTrials.gov Identifier: NCT00224341
  Purpose

The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial fibrillation (AF). Two new algorithms (post-AF response and ventricular rate stabilization [VRS]) will be assessed in a combined pathway, compared to a control group. The efficacy of the overall available therapies to prevent AF and its symptoms will then be assessed also.


Condition Intervention Phase
Sick Sinus Syndrome
Brady-Tachy Syndrome
 Device: Pacemaker Vitatron Selection 9000
Device: Pacemaker Vitatron T70
 Phase IV

Genetics Home Reference related topics:   Brugada syndrome    familial atrial fibrillation    short QT syndrome   

MedlinePlus related topics:   Arrhythmia   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study

Further study details as provided by Vitatron France:

Primary Outcome Measures:
  • Show clinical benefit of post-AF response and VRS algorithms, when combined versus compared with a control group: In a conventional dual chamber (DDD) configuration
  • In a configuration including all the preventive pacing therapies of the device
  • The primary endpoint is the atrial fibrillation burden.

Secondary Outcome Measures:
  • Assess the effect of post-AF response and VRS, when combined versus compared with a control group, in a conventional DDD configuration and another configuration which includes all PPT, on: Number (Nb) of hospitalizations
  • Nb of cardioversions
  • Symptom score
  • Restarts
  • Daily incidence of AF
  • Mean sinus rhythm duration
  • Assess clinical benefit of the overall AF therapies, as compared with the first four algorithms of the previous device (one continuous overdrive +3 triggered overdrive), on the same outcomes as above and AF burden

Estimated Enrollment:   360
Study Start Date:   November 2003
Estimated Study Completion Date:   November 2006

Detailed Description:

Due to anti-arrhythmic pharmacological drugs failure to suppress atrial fibrillation (AF), interest towards preventive pacing treatments is increasing. The importance of this option in the panoply of the preventive tools is fully justified, only by considering the insufficiency, the complexity, or the poor reproducibility of the other non-pharmaceutical approaches.

Preventive pacing therapies rely on their potential effect on different onset modalities emphasized by previous studies, and more generally by stabilizing atrial tissue when potential triggers are appearing.

On top of that, cardiac stimulator can deliver these therapies when identifying these triggers but also can offer incomparable diagnostic tools, in terms of sensitivity, specificity and continuity in the monitoring.

Four preventive pacing therapies have already been evaluated, the objective of this study is to show the clinical benefit brought by the new features of the Selection 9000 / Vitatron T70 DR.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patient with documented atrial fibrillation: at least one episode of paroxysmal AF documented 6 months prior to inclusion, lasting more than one minute
  • Patient with a brady-tachy syndrome or a sick sinus syndrome, with a permanent pacing indication
  • Atrial lead with a tip-to-ring interval equal to or less than 12 mm
  • Patient who agrees with and has signed the informed consent

Exclusion Criteria:

  • Permanent AF
  • AF related to a reversible cause
  • One electrical cardioversion 6 months prior to inclusion
  • Unstable angina
  • Myocardial infarction (MI) less than 3 months
  • Planned cardiac surgery or performed in the last 3 months
  • Congestive heart failure, New York Heart Association (NYHA) class IV
  • Life expectancy less than 18 months
  • Patient participating in other studies
  • Patient not able to follow the FU calendar
  • Less than 18 years of age
  • Pregnancy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224341

Contacts
Contact: Christèle Pelade, Engineer     01 53 98 83 00     christele.pelade@vitatron.com    
Contact: Bérangère Leroy, Engineer     01 53 98 83 00     berangere.leroy@vitatron.com    

Locations
France
CMC Parly II     Recruiting
      Le Chesnay, France, 78150
      Contact: Patrick Attuel, MD     +33 139637000        
      Principal Investigator: Patrick Attuel, MD            
CH Toulon     Recruiting
      Toulon, France, 83056
      Contact: Isabelle Canavy, MD     +33 494616069        
      Principal Investigator: Isabelle Canavy, MD            
      Sub-Investigator: Alex Baralla, MD            
      Sub-Investigator: Jean Julienne, MD            
Institut Arnalt Tzanck     Recruiting
      Saint Laurent du Var, France, 06721
      Contact: Claude Mariottini, MD     ++33 4 92 27 37 27        
      Principal Investigator: Claude Mariottini, MD            
      Sub-Investigator: Philippe Durand, MD            
CH     Recruiting
      Metz, France, 57000
      Contact: Michel Boursier, MD     +33 387553231        
      Principal Investigator: Michel Boursier, MD            
CH     Recruiting
      Thionville, France, 57100
      Contact: Jean-Yves Thisse, MD     +33 382558300        
      Principal Investigator: Jean-Yves Thisse, MD            
      Sub-Investigator: Philippe Houplon, MD            
CH     Recruiting
      Mulhouse, France, 68051
      Contact: Jacques Levy, MD     +33 389647120        
      Principal Investigator: Jacques Levy, MD            
CMCO     Recruiting
      Schiltigheim, France, 67303
      Contact: François Philippot, MD     +33 3 88628318        
      Principal Investigator: François Philippot, MD            
CH     Completed
      Colmar, France, 68024
CH     Recruiting
      Avignon, France, 84902
      Contact: Jean-Paul Faugier, MD     +33 432753141        
      Principal Investigator: Jean-Paul Faugier, MD            
CH     Recruiting
      Martigues, France, 136995
      Contact: André Ebagosti, MD     +33 442432540        
      Principal Investigator: André Ebagosti, MD            
CHU La Timone     Recruiting
      Marseille, France, 13385
      Contact: Jean-Claude Deharo, Pr     +33 491386575        
      Principal Investigator: Jean-Claude Deharo, Pr            
CH     Recruiting
      Evreux, France, 27000
      Contact: Bouchaib Deriouich, MD            
      Principal Investigator: Bouchaib Deriouich, MD            
CH     Recruiting
      Auxerre, France, 89011
      Contact: François-Xavier Soto, MD     +33 386484658        
      Principal Investigator: François-Xavier Soto, MD            
      Sub-Investigator: Stéphane Mourot, MD            
Clinique Ambroise Paré     Recruiting
      Neuilly sur Seine, France, 92200
      Contact: Olivier Thomas, MD     +33 146418965        
      Principal Investigator: Olivier Thomas, MD            
HIA Percy     Recruiting
      Clamart, France, 92141
      Contact: Christian Plotton, MD     +33 141466241        
      Principal Investigator: Christian Plotton, MD            
CHU     Recruiting
      Saint Etienne, France, 42055
      Contact: Antoine Da Costa, MD     +33 477828340        
      Principal Investigator: Antoine Da Costa, MD            
CH     Recruiting
      Castres, France, 81108
      Contact: Pascal Chavernac, MD     +33 563716328        
      Principal Investigator: Pascal Chavernac, MD            
CH     Recruiting
      Grenoble, France, 38043
      Contact: Pascal Defaye, MD     +33 476765507        
      Principal Investigator: Pascal Defaye, MD            
Clinique de la Casamance     Recruiting
      Marseille, France, 13000
      Contact: Jacques Faure, MD            
      Principal Investigator: Jacques Faure, MD            
CHU     Recruiting
      Rouen, France, 76035
      Contact: Frédéric Anselme, MD     +33 232888111        
      Principal Investigator: Frédéric Anselme, MD            
      Sub-Investigator: Arnaud Savoure, MD            
CH     Recruiting
      Le Havre, France, 76083
      Contact: Isabelle Cheradame, MD     +33 232733155        
      Principal Investigator: Isabelle Cheradame, MD            
      Sub-Investigator: Jean-Pierre Favier, MD            
CH     Recruiting
      Dunkerque, France, 59240
      Contact: Jean-Charles Aisenfarb, MD     +33 328285623        
      Principal Investigator: Jean-Charles Aisenfarb, MD            
CH Saint Philibert     Recruiting
      Lomme, France, 59160
      Contact: Pierre Graux, MD     +33 320225058        
      Principal Investigator: Pierre Graux, MD            
CHG     Recruiting
      Abbeville, France, 80100
      Contact: Jean-Ernst Poulard, MD     +33 322255200        
      Principal Investigator: Jean-Ernst Poulard, MD            
Polyclinique Saint Laurent     Recruiting
      Rennes, France, 35000
      Contact: Jean-Michel Baisset, MD            
      Principal Investigator: Jean-Michel Baisset, MD            
CHU     Recruiting
      Caen, France, 14033
      Contact: Patrice Scanu, MD     +33 231063106        
      Principal Investigator: Patrice Scanu, MD            
CH René Pleven     Recruiting
      Dinan, France, 22101
      Contact: Patrick Bazin, MD     +33 296857250        
      Principal Investigator: Patrick Bazin, MD            
CHU     Recruiting
      Rennes, France, 35033
      Contact: Philippe Mabo, Pr     +33 299282527        
      Principal Investigator: Philippe Mabo, Pr            
Hopital Privé     Recruiting
      Antony, France, 92160
      Contact: Didier Gedin, MD     +33 146743700        
      Principal Investigator: Didier Gedin, MD            
      Sub-Investigator: Cyrus Moini, MD            
CH     Recruiting
      Limoges, France, 87042
      Contact: Christophe D'Ivernois, MD     +33 555056310        
      Principal Investigator: Christophe D'Ivernois, MD            
Hopital Cardiologique du Haut Leveque     Recruiting
      Pessac, France, 33604
      Contact: Jacques Clementy, Pr     +33 557656471        
      Principal Investigator: Jacques Clementy, Pr            
      Sub-Investigator: Sylvain Reuter, MD            
Clinique de Bordeaux Cauderan     Recruiting
      Bordeaux, France, 33300
      Contact: Laurent Gencel, MD            
      Principal Investigator: Laurent Gencel, MD            
Hopital Privé Claude Galien     Recruiting
      Quincy-sous-Sénart, France, 91480
      Contact: Dominique Bleinc, MD     +33 169399132        
      Principal Investigator: Dominique Bleinc, MD            
Clinique Bouchard     Recruiting
      Marseille, France, 13006
      Contact: Maxime Guenoun, MD     +33 491159062        
      Principal Investigator: Maxime Guenoun, MD            
      Sub-Investigator: Olivier Roux, MD            
CH     Recruiting
      Valenciennes, France, 59322
      Contact: Benaissa Agraou, MD     +33 327143041        
      Principal Investigator: Benaissa Agraou, MD            
CHU     Recruiting
      Montpellier, France, 34295
      Contact: Jean-Marc Davy, Pr     +33 467336164        
      Principal Investigator: Jean-Marc Davy, Pr            
      Sub-Investigator: Jean-Luc Pasquié, MD            
      Sub-Investigator: Franck Raczka, MD            
CH     Recruiting
      Dole, France, 39108
      Contact: Hugues Zimmermann, MD     +33 384798065        
      Principal Investigator: Hugues Zimmermann, MD            

Sponsors and Collaborators
Vitatron France

Investigators
Principal Investigator:     Patrick Attuel, MD     CNOM    
  More Information


Publications:
Camm AJ on behalf of the AFTherapy Study Group. The Atrial Fibrillation Therapy Study. Présentation orale au cours du Congrès de l’ESC à Stockholm, Septembre 2001.
 
ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. European Heart Journal 2001 ; 22 : 1852–1923
 
Tse HF, Lau CP, Ayers GM. Incidence and modes of onset of early reinitiation of atrial fibrillation after successful internal cardioversion, and its prevention by intravenous sotalol. Heart. 1999 Sep;82(3):319-24.
 
Falk RH. Management of atrial fibrillation--radical reform or modest modification? N Engl J Med. 2002 Dec 5;347(23):1883-4. No abstract available.
 
Van Gelder IC, Hagens VE, Bosker HA, Kingma JH, Kamp O, Kingma T, Said SA, Darmanata JI, Timmermans AJ, Tijssen JG, Crijns HJ; Rate Control versus Electrical Cardioversion for Persistent Atrial Fibrillation Study Group. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1834-40.
 
Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33.
 
Hohnloser SH, Kuck KH, Lilienthal J. Rhythm or rate control in atrial fibrillation--Pharmacological Intervention in Atrial Fibrillation (PIAF): a randomised trial. Lancet. 2000 Nov 25;356(9244):1789-94.
 
Hohnloser SH, Kuck KH. Randomized trial of rhythm or rate control in atrial fibrillation: the Pharmacological Intervention in Atrial Fibrillation Trial (PIAF). Eur Heart J. 2001 May;22(10):801-2. No abstract available.
 
Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66.
 
Defaye P, Dournaux F, Mouton E. Prevalence of supraventricular arrhythmias from the automated analysis of data stored in the DDD pacemakers of 617 patients: the AIDA study. The AIDA Multicenter Study Group. Automatic Interpretation for Diagnosis Assistance. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):250-5.
 
Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6.
 
Connolly SJ, Kerr CR, Gent M, Roberts RS, Yusuf S, Gillis AM, Sami MH, Talajic M, Tang AS, Klein GJ, Lau C, Newman DM. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. Canadian Trial of Physiologic Pacing Investigators. N Engl J Med. 2000 May 11;342(19):1385-91.
 
Gillis AM, Connolly SJ, Lacombe P, Philippon F, Dubuc M, Kerr CR, Yee R, Rose MS, Newman D, Kavanagh KM, Gardner MJ, Kus T, Wyse DG. Randomized crossover comparison of DDDR versus VDD pacing after atrioventricular junction ablation for prevention of atrial fibrillation. The atrial pacing peri-ablation for paroxysmal atrial fibrillation (PA (3)) study investigators. Circulation. 2000 Aug 15;102(7):736-41.
 
Edvardson N. Efficacy of preventive pacing therapies in Paroxysmal Atrial Fibrillation - IV International meeting - Atrial Fibrillation 2001 : 161-164.
 
Hoffmann E, Janko S, Steinbeck G and al. Onset scenarios of paroxysmal atrial fibrillation using new diagnostic pacemaker functions. Pacing Clin Electrophysiol. 2000 ; 23(4) : 656 (abstract).
 
Hoffmann E, Janko S, Steinbeck G and al. Analysis of Onset Mechanisms of Paroxysmal Atrial Fibrillation through a Pacemaker with Continuous Monitoring Capabilities. Pacing Clin Electrophysiol. 2000 ; 23(4) : 656 (poster).
 
Capucci A, Gropppi F, Ruiter J on behalf of the AFTherapy Study Group. Re-initiation of atrial Fibrillation Investigated Through pacemaker Focussed Diagnostics. Europace 2000 – Supplement 1.
 
Tse HF, Lau CP, Ayers GM. Atrial pacing for suppression of early reinitiation of atrial fibrillation after successful internal cardioversion. Eur Heart J. 2000 Jul;21(14):1167-76.
 
Lee JK, Yee R, Braney M, Stoop G, Begemann M, Dunne C, Klein GJ, Krahn AD, Van Hemel NM. Acute testing of the rate-smoothed pacing algorithm for ventricular rate stabilization. Pacing Clin Electrophysiol. 1999 Apr;22(4 Pt 1):554-61.
 
Lau CP, Jiang ZY, Tang MO. Efficacy of ventricular rate stabilization by right ventricular pacing during atrial fibrillation. Pacing Clin Electrophysiol. 1998 Mar;21(3):542-8.
 
Daoud EG, Weiss R, Bahu M, Knight BP, Bogun F, Goyal R, Harvey M, Strickberger SA, Man KC, Morady F. Effect of an irregular ventricular rhythm on cardiac output. Am J Cardiol. 1996 Dec 15;78(12):1433-6.
 
Yee R, Meijer A and Winkler WB and al. Effect of Chronic Ventricular Rate Stabilization on Rate Irregularity in Patients with Permanent Atrial Fibrillation. Progress in Clinical Pacing – Rome 2002 : 52 (abstract)
 
Pfaiffer L, Canby P, Navone A and al. Impact of Atrial Rhythm Diagnostics on Clinical Management. Europace Supplements 2002 ; 3 : A 152 (abstract).
 
Gregoratos G, Abrams J, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, Kerber RE, Naccarelli GV, Schoenfeld MH, Silka MJ, Winters SL. ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices--summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). J Am Coll Cardiol. 2002 Nov 6;40(9):1703-19. No abstract available.
 
Jenkins LS, Bubien RS. Quality of life in patients with atrial fibrillation. In : DiMarco JP, ed. Cardiology Clinics. Atrial Fibrillation. Orlando : WB Saunders, 1996 ; 597-606
 
Carlioz R, Perrier E, Thomas O and al. Accuracy of atrial Tachyarrhythmia Monitoring in the Selection Device : Correlation with an External Holter Recording. Europace Suppl 2001 ; 2 : B199.
 
Jenkins LS. Quality of life in Patients with Atrial Fibrillation. Circulation 1995 ; 92 (I) : 490 (abstract).
 
Bubien RS, Knotts-Dolson SM, Plumb VJ, Kay GN. Effect of radiofrequency catheter ablation on health-related quality of life and activities of daily living in patients with recurrent arrhythmias. Circulation. 1996 Oct 1;94(7):1585-91.
 

Study ID Numbers:   ARREST-AF
First Received:   September 20, 2005
Last Updated:   October 17, 2006
ClinicalTrials.gov Identifier:   NCT00224341
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by Vitatron France:
Pacemaker  
Atrial Fibrillation  
Prevention pacing  
Algorithms  
Sick sinus syndrome + Atrial Fibrillation  

Study placed in the following topic categories:
Heart Diseases
Heart Block
Arrhythmia, Sinus
Atrial Fibrillation
Sick Sinus Syndrome
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Disease
Pathologic Processes
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

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