Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing - Full Text View

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00286858

Purpose

This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.

Condition	Intervention	Phase
Bradycardia Sick Sinus Syndrome Heart Block	Device: Insignia Ultra and Insignia AVT	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Clinical Observations of Automatic Algorithms for Cardiac Pacing

Further study details as provided by Guidant Corporation:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	900
Study Start Date:	September 2006
Estimated Study Completion Date:	July 2009

Intervention Details:

Regular AV-Delay increase to allow for intrinsic AV conduction, if present.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Consecutive patients with indication for a dual chamber pacemaker and not having a complete AV-block are invited to participate.

Criteria

Inclusion Criteria:

Dual chamber pacemaker (INSIGNIA ULTRA or AVT pacemaker), implant not older than 60 days, estimated life expectancy more than one year in case of associated illness, Age ≥ 18 years, signed patient information.

Exclusion Criteria:

Indication for conventional treatment with ventricular resynchronisation or by implantable defibrillator during inclusion, implanted for severe permanent AVB (AVB 2/1 and complete), PR > 250 ms, implant of the device older than 60 days before the inclusion date, Heart transplant foreseen within six months, unexplained syncope.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286858

Contacts

Contact: Elisabeth Mouton, MD

+33 1 47144654

emouton@guidant.com

Locations

France
Clinique Ambroise Paré	Recruiting
Neuilly sur Seine, France, 92200
Contact: Olivier Thomas, MD
Principal Investigator: Olivier Thomas, MD
Hôpital Nord	Recruiting
Marseille, France, 13915
Principal Investigator: Pascale Sebragia, MD
Principal Investigator: Alexandre J Trigano, MD
Casamance	Recruiting
La Ciotat, France, 13600
Principal Investigator: Jérôme Fabre, MD
Hôpital Fontenoy	Recruiting
Chartres, France, 28000
Principal Investigator: Hassan Belfaqih, MD
CH Cherbourg	Recruiting
Cherbourg, France, 50000
Principal Investigator: Didier Binet, MD
Sub-Investigator: Philippe Loiselet, MD
CH de Laval	Recruiting
Laval, France, 53024
Principal Investigator: Pierre Bienvenu, MD
CH Maréchal Joffre	Recruiting
Perpignan, France, 66046
Principal Investigator: Patrick Chopat, MD
Sub-Investigator: Pierre Sultan, MD
CH privé St. Martin	Recruiting
Caen, France, 14050
Principal Investigator: Olivier Citerne, MD
CH de La Roche sur Yon	Recruiting
La Roche sur Yon, France, 85025
Principal Investigator: Claude Gully, MD
CHG de Dinan	Recruiting
Dinan, France, 22100
Principal Investigator: Patrick Bazin, MD
Sub-Investigator: André Guillemot, MD
CHG de Pau	Recruiting
Pau, France, 64046
Principal Investigator: Nicolas Delarche, MD
CHG Saint Louis - SIH Eure Seine	Recruiting
Evreux, France, 27023
Principal Investigator: Bouchaïb DERIOUICH, MD
CHI de Castres	Recruiting
Castres, France, 81100
Principal Investigator: P. CHAVERNAC, MD
CHP de la Loire	Recruiting
St. Etienne, France, 42000
Principal Investigator: Frédéric DUBOIS, MD
CHR la Source	Recruiting
Orleans, France, 45067
Principal Investigator: Olivier BIZEAU, MD
Sub-Investigator: Marc GORALSKI, MD
CHU Albert Michalon	Recruiting
Grenoble, France, 38043
Principal Investigator: Pascal DEFAYE, MD
CHU de Point à pitre	Recruiting
Point à Pitre, France, 97159
Principal Investigator: Vincent TRANCART, MD
Clinique A. Brillard	Recruiting
NOGENT/ MARNE, France, 94130
Principal Investigator: Olivier GARTENLAUB, MD
Clinique Belledone	Recruiting
St Martin d'Heres, France, 38400
Principal Investigator: Patrick Hallali, MD
Principal Investigator: Jean-Eric Lanney de Courten, MD
Principal Investigator: Eric Page, MD
Principal Investigator: Jean Pellet, MD
Principal Investigator: Luc Petit, MD
Principal Investigator: Jean-Philippe SICHE, MD
Clinique Cardiologique Aressy	Recruiting
Aressy, France, 64320
Principal Investigator: Jacques CASASSUS, MD
CH DAX	Recruiting
DAX, France, 40100
Principal Investigator: Bernard LAHITTON, MD
Clinique des Cèdres	Recruiting
Brive la Gaillard, France, 19316
Principal Investigator: Eric ESPALIAT, MD
Principal Investigator: Jean-François MARTAILLÉ, MD
Clinique du Lac et d'Argonay	Recruiting
Argonay, France, 74370
Principal Investigator: Thierry De La Bourdonnaye, MD
Principal Investigator: Bernard EMONNOT, MD
Principal Investigator: Philippe MANSOUR, MD
Clinique Paulmy	Recruiting
Bayonne, France, 64100
Principal Investigator: Lotfi Larouchi, MD
Clinique St Hilaire	Recruiting
Rouen, France, 76000
Principal Investigator: Pierre LEFRANC, MD
Hôpital de Brabois	Recruiting
Vandoeuvre les Nancy, France, 54511
Principal Investigator: Hugues BLANGY, MD
Nouvelles Cliniques Nantaises	Recruiting
Nantes, France, 44110
Principal Investigator: Jean-Pierre CEBRON, MD
Principal Investigator: Daniel Gras, MD
Polyclinique Bordeaux-Cauderan	Recruiting
Bordeaux, France, 33200
Principal Investigator: Laurent GENCEL, MD
Polyclinique Louis Pasteur	Recruiting
Essey les Nancy, France, 54271
Principal Investigator: Karim BEL HADJ, MD
Polyclinique Sévigné	Recruiting
Cesson Sevigne, France, 35510
Principal Investigator: Olivier LEBORGNE, MD
Principal Investigator: Christophe RAVELEAU, MD
Clinique Pasteur	Recruiting
Toulouse, France, 31076
Principal Investigator: Jean-Paul ALBENQUE, MD
Principal Investigator: Serge BOVEDA, MD
CH Nevers	Recruiting
Nevers, France, 58033
Principal Investigator: Grégoire Longueville, MD
Principal Investigator: Bernard VITOUX, MD
CH Emile Muller	Recruiting
Mulhouse, France, 68070
Principal Investigator: J. Levy, MD
CHRU- Hôpital Nord	Recruiting
Amiens, France, 80054
Principal Investigator: Jean-Luc Rey, MD
Polyclinique du Bois	Recruiting
Lille, France, 59003
Principal Investigator: Frédéric FOSSATI, MD
Principal Investigator: Philippe GUIMIER, MD
CH Beauvais	Recruiting
Beauvais, France, 60021
Principal Investigator: Ayman ALDAOUD, MD
CH d'Arles	Recruiting
Arles, France, 13200
Principal Investigator: ORTUNO, MD
CHU Nîmes	Recruiting
Nîmes, France, 30006
Principal Investigator: Lionel BECK, MD
Principal Investigator: WINNUM, MD
Clinique Notre Dame	Recruiting
Draguignan, France, 83300
Principal Investigator: BOYER, MD
Principal Investigator: CHAIX, MD
Principal Investigator: CHALVIDAN, MD
Principal Investigator: DEDOLE, MD
Principal Investigator: GARCIA, MD
Clinique de L'Ormeau	Recruiting
Tarbes, France, 65000
Principal Investigator: Michel VOGLIMACCI, MD

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:

Olivier THOMAS, MD

Clinique Ambroise Paré

More Information

Responsible Party:	Guidant France ( Elisabeth Mouton )
Study ID Numbers:	Beluga
Study First Received:	February 2, 2006
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00286858
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Heart Diseases
Arrhythmia, Sinus
Heart Block

Bradycardia
Sick Sinus Syndrome
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Disease
Pathologic Processes
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009