Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity. - Full Text View

Purpose

The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.

Condition	Intervention	Phase
Bradycardia; Sick Sinus Syndrome, AV Block	Device: Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2 Procedure: Required pacemaker setting	Phase IV

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Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	IntAct, Study on Promotion of Intrinsic Activity.

Further study details as provided by Medtronic - Vitatron:

Primary Outcome Measures:

Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization

Secondary Outcome Measures:

Occurrence of possible undesired consequences of the RVP algorithm (e.g. retrograde conduction; AF burden) and adverse events in the periods with the algorithm switched ON versus OFF, 4 and 8 weeks after randomization
Patient’s opinion about treatment (on a six-point scale), at 4 and 8 weeks after randomization
explorative subanalysis on patients with different arrhythmias and/or conducting system defects to investigate in which type of patients the RVP algorithm will have the largest impact on %VP
Reproducibility of the %VP assessment, comparison %VP during Baseline periode and 4-week study period with RVP OFF

Estimated Enrollment:	150
Study Start Date:	April 2004
Estimated Study Completion Date:	April 2006

Detailed Description:

Electrical stimulation in the apex of the right ventricle ( ventricular pacing) usually improves the heart function of patients with a pacemaker and can even be life-saving. However, evidence is accumulating that ventricular pacing may also have undesired long-term cardiac effects. Therefore, it makes sense to limit ventricular pacing to the absolute required minimum. The functionality RVP (Refined Ventricular Pacing) in the C-series 2nd generation pacemakers of Vitatron B.V. Arnhem, the Netherlands is designed to reduce ventricular pacing.

After implantation of the Vitatron C50 D model C50A2 (pacemaker) or Vitatron C60 DR model C60A2 (pacemaker) and a 4-6 weeks stabilization period, proper functioning of pacemaker and leads (stimulation- and sensing parameters) is checked. The pacemakers will be programmed according to predefined settings.

In the following 4-weeks Baseline period diagnostic data (atrial fibrillation burden and percentage of ventricular pacing (% VP)) are collected in the pacemaker memory. Based on these data, patients will be excluded from further participation (patients with more than 15% atrial fibrillation) or subdivided into three groups: (a) < 30% VP (30- VP group), (b) >30% VP, Sick Sinus Syndrome and normal conductivity (SSS group), (c) >30% VP, 1st or 2nd degree AV block. Patients in these three groups will be treated for 4 weeks alternatively with the RVP functionality switched ON or OFF. The order will be determined by randomization. At the end of these two cross-over periods the % VP and the judgment of the patients of the last period will be assessed. Adverse events will be recorded from the moment of study enrolment.

Eligibility

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

Criteria

Inclusion Criteria:

Patients shall be willing to sign the Patient Informed Consent for this study
Patients shall have at least one of the following indications for a pacemaker: - Sick Sinus Syndrome with normal QRS complexes
First degree AV block with a PR interval <_220 ms for patients <_ 70 years of age, or <_ 260 for patients over 70 years
Second-degree AV block, mobitz I (wenckebach) or mobitz II
Patients shall be available for follow-up for the duration of their participation.

Exclusion Criteria:

Patients involved in another investigation study conducted in parallel to this study
Patients younger than 18 years of age and/or patients that do NOT meet other local requirements for participation
Pregnant patients
Patients with lead integrity problems (and the lead is not being replaced)
Patients with persistant AF
Patients with a complete AV block
Patients with NYHA (New York Heart Association0 class III and IV
Patients who underwent thoracic surgery in the last three months or are expected to have in the near future
Patients with a 2:1 block
Patients with a life expectancy less than half a year

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156741

Show 30 Study Locations

Sponsors and Collaborators

Medtronic - Vitatron

Investigators


Study Chair:	Ludwig Binner, MD	Universitätsklinikum Ulm, Ulm, Germany

Study Director:	Chris van Groeningen, MD	Vitatron B.V., Arnhem, The Netherlands

More Information

Publications:

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, Goldman BS, Yee R, Irwin ME, Wilson SL, Ashton T, Philippon F, Fraser JD, Clavette P, Tyers GF. Cardiac pacing in Canada in 1998: working towards optimal pacing therapy. Canadian Working Group on Cardiac Pacing. Can J Cardiol. 1998 Sep;14(9):1115-20.

Lamas GA, Orav EJ, Stambler BS, Ellenbogen KA, Sgarbossa EB, Huang SK, Marinchak RA, Estes NA 3rd, Mitchell GF, Lieberman EH, Mangione CM, Goldman L. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. 1998 Apr 16;338(16):1097-104.

[No authors listed] Danish pacemaker and ICD register. 1999. Pacing Clin Electrophysiol. 2000 Oct;23(10 Pt 2):S1-93. No abstract available.

Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23.

Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62.

The MOST Trial Investigators. Effect of pacing mode and cumulative percent time ventricular paced on heart failure in patients with sick sinus syndrome and baseline QRS duration < 120 milliseconds in MOST. PACE 2002; 561 Abstract 155.

The MOST Trial Investigators. Baseline QRS duration ≥ 120 milliseconds and cumulative percent time ventricular paced predicts increased risk of heart failure, stroke and death in DDDR-paced patients with sick sinus syndrome in MOST. PACE 2002; 690 Abstract 672

[No authors listed] Uniform requirements for manuscripts submitted to biomedical journals. International Committee of Medical Journal Editors. N Engl J Med. 1991 Feb 7;324(6):424-8. No abstract available.

Andersen HR, Thuesen L, Bagger JP, Vesterlund T, Thomsen PE. Prospective randomised trial of atrial versus ventricular pacing in sick-sinus syndrome. Lancet. 1994 Dec 3;344(8936):1523-8.

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.

Andersen HR, Kristensen L, Nielsen JC, Mortensen PT, Pedersen OL, Pedersen AK, Atrial verses dual chamber pacing in patients with sick sinus syndrome, atrial fibrillation, congestive heart failure and mortality during follow-up in a randomised trial of 177 patients. PACE 2001; 24: 575 Abstract 174

Barold SS. Indications for permanent cardiac pacing in first-degree AV block: class I, II, or III? Pacing Clin Electrophysiol. 1996 May;19(5):747-51. No abstract available.

Bode F, Wiegand U, Katus HA, Potratz J. Inhibition of ventricular stimulation in patients with dual chamber pacemakers and prolonged AV conduction. Pacing Clin Electrophysiol. 1999 Oct;22(10):1425-31.

Boute W, Brunekreeft W. AV delay hysteresis in dual chamber pacing: initial results from the Ruby Clinical Investigation. Vitatext 1994; 1: 13-14

Brandt J, Anderson H, Fahraeus T, Schuller H. Natural history of sinus node disease treated with atrial pacing in 213 patients: implications for selection of stimulation mode. J Am Coll Cardiol. 1992 Sep;20(3):633-9.

Carisma MB, Manalo JM, Chua WT. Atrioventricular conduction in sick sinus syndrome. Pacing Clin Electrophysiol. 1988 Nov;11(11 Pt 2):1636-40.

Charles RG, McComb JM. Systematic trial of pacing to prevent atrial fibrillation (STOP-AF). Heart. 1997 Sep;78(3):224-5. No abstract available.

Cohen SI, Frank HA. Preservation of active atrial transport; an important clinical consideration in cardiac pacing. Chest. 1982 Jan;81(1):51-4.

Connolly SJ, Talajic M, Roy D, Tang ASL, Lav C, Bonilla L, Gillis AM. The effect of pacemaker selection on functional capacity in the Canadian Trial of Physiologic Pacing (CTOPP). Circulation 1999; 100(suppl I): I-465

Clarke KW, Connelly DT, Charles RG. Single chamber atrial pacing: an underused and cost-effective pacing modality in sinus node disease. Heart. 1998 Oct;80(4):387-9.

Elshot SR, el Gamal MI, Tielen KH, van Gelder BM. Incidence of atrioventricular block and chronic atrial flutter/fibrillation after implantation of atrial pacemakers; follow-up of more than ten years. Int J Cardiol. 1993 Mar;38(3):303-8.

Grimm W, Langenfeld H, Maisch B, Kochsiek K. Symptoms, cardiovascular risk profile and spontaneous ECG in paced patients: a five-year follow-up study. Pacing Clin Electrophysiol. 1990 Dec;13(12 Pt 2):2086-90.

Harper GR, Pina IL, Kutalek SP. Intrinsic conduction maximizes cardiopulmonary performance in patients with dual chamber pacemakers. Pacing Clin Electrophysiol. 1991 Nov;14(11 Pt 2):1787-91.

Haywood GA, Ward J, Ward DE, Camm AJ. Atrioventricular Wenckebach point and progression to atrioventricular block in sinoatrial disease. Pacing Clin Electrophysiol. 1990 Dec;13(12 Pt 2):2054-8.

Hesselson AB, Parsonnet V, Bernstein AD, Bonavita GJ. Deleterious effects of long-term single-chamber ventricular pacing in patients with sick sinus syndrome: the hidden benefits of dual-chamber pacing. J Am Coll Cardiol. 1992 Jun;19(7):1542-9. Review.

Jutzy RV, Feenstra L, Pai R, Florio J, Bansal R, Aybar R, Levine PA. Comparison of intrinsic versus paced ventricular function. Pacing Clin Electrophysiol. 1992 Nov;15(11 Pt 2):1919-22.

Kallryd A, Kruse I, Ryden L. Atrial inhibited pacing in the sick sinus node syndrome: clinical value and the demand for rate responsiveness. Pacing Clin Electrophysiol. 1989 Jun;12(6):954-61.

Kerr CR, Tyers GF, Vorderbrugge S. Atrial pacing: efficacy and safety. Pacing Clin Electrophysiol. 1989 Jul;12(7 Pt 1):1049-54.

Kristensen L, Nielsen JC, Andersen HR. Outcome of patients with sick sinus syndrome treated by different pacing modalities. In Ovsyshcher IE (ed): Cardiac arrhythmias and device therapy results and perspectives for the new century. Futura Publishing Company Inc., Armonk NY, 2000, 323-332.

Leclercq C, Gras D, Le Helloco A, Nicol L, Mabo P, Daubert C. Hemodynamic importance of preserving the normal sequence of ventricular activation in permanent cardiac pacing. Am Heart J. 1995 Jun;129(6):1133-41.

Mattioli AV, Vivoli D, Mattioli G. Influence of pacing modalities on the incidence of atrial fibrillation in patients without prior atrial fibrillation. A prospective study. Eur Heart J. 1998 Feb;19(2):282-6.

Montanez A, Hennekens CH, Zebede J, Lamas GA. Pacemaker mode selection: the evidence from randomized trials. Pacing Clin Electrophysiol. 2003 May;26(5):1270-82. Review.

Narula OS. Atrioventricular conduction defects in patients with sinus bradycardia. Analysis by His bundle recordings. Circulation. 1971 Dec;44(6):1096-110. No abstract available.

Nielsen JC, Pedersen AK, Mortensen PT, Andersen HR. Programming a fixed long atrioventricular delay is not effective in preventing ventricular pacing in patients with sick sinus syndrome. Europace. 1999 Apr;1(2):113-20.

Nielsen JC, Kristensen L, Pedersen AK, Mortensen PT, Pedersen OL. Changes in left atrial size and left ventricular size and functioning during follow-up of 177 patients with sick sinus syndrome randomised to atrial or dual chamber pacing. PACE 2001; 24: 697 Abstract 633

Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. 2003 Aug 20;42(4):614-23.

Prech M, Grygier M, Mitkowski P, Stanek K, Skorupski W, Moszynska B, Zerbe F, Cieslinski A. Effect of restoration of AV synchrony on stroke volume, exercise capacity, and quality-of-life: can we predict the beneficial effect of a pacemaker upgrade? Pacing Clin Electrophysiol. 2001 Mar;24(3):302-7.

Rosenqvist M, Brandt J, Schuller H. Long-term pacing in sinus node disease: effects of stimulation mode on cardiovascular morbidity and mortality. Am Heart J. 1988 Jul;116(1 Pt 1):16-22.

Rosenqvist M, Bergfeldt L, Haga Y, Ryden J, Ryden L, Owall A. The effect of ventricular activation sequence on cardiac performance during pacing. Pacing Clin Electrophysiol. 1996 Sep;19(9):1279-86.

Santini M, Alexidou G, Ansalone G, Cacciatore G, Cini R, Turitto G. Relation of prognosis in sick sinus syndrome to age, conduction defects and modes of permanent cardiac pacing. Am J Cardiol. 1990 Mar 15;65(11):729-35.

Stangl K, Seitz K, Wirtzfeld A, Alt E, Blomer H. Differences between atrial single chamber pacing (AAI) and ventricular single chamber pacing (VVI) with respect to prognosis and antiarrhythmic effect in patients with sick sinus syndrome. Pacing Clin Electrophysiol. 1990 Dec;13(12 Pt 2):2080-5.

Stierle U, Kruger D, Vincent AM, Mitusch R, Giannitsis E, Wiegand U, Potratz J. An optimized AV delay algorithm for patients with intermittent atrioventricular conduction. Pacing Clin Electrophysiol. 1998 May;21(5):1035-43.

Sulke N, Chambers J, Dritsas A, Sowton E. A randomized double-blind crossover comparison of four rate-responsive pacing modes. J Am Coll Cardiol. 1991 Mar 1;17(3):696-706.

Sutton R, Kenny RA. The natural history of sick sinus syndrome. Pacing Clin Electrophysiol. 1986 Nov;9(6 Pt 2):1110-4. Review.

Toff WD, Skehan JD, De Bono DP, Camm AJ. The United Kingdom pacing and cardiovascular events (UKPACE) trial. United Kingdom Pacing and Cardiovascular Events. Heart. 1997 Sep;78(3):221-3. No abstract available.

Vardas PE, Simantirakis EN, Parthenakis FI, Chrysostomakis SI, Skalidis EI, Zuridakis EG. AAIR versus DDDR pacing in patients with impaired sinus node chronotropy: an echocardiographic and cardiopulmonary study. Pacing Clin Electrophysiol. 1997 Jul;20(7):1762-8.

Woodend K, Tang SI, Irvine J, Connolly S, Lav C, Paquette M, Newman D. Pacemaker dependency conditions the QOL benefits of physiologic over VVI pacing: Canadian Trial of Physiologic Pacing (CTOPP). Circulation 1999; 100(suppl I): I-20

Study ID Numbers:	CMD 287
First Received:	September 7, 2005
Last Updated:	September 26, 2005
ClinicalTrials.gov Identifier:	NCT00156741
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Research Ethics Committee

Keywords provided by Medtronic - Vitatron:

Refined ventricular pacing

Study placed in the following topic categories:

Heart Diseases

Arrhythmia, Sinus

Heart Block

Bradycardia

Atrioventricular Block

Sick Sinus Syndrome

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Medtronic - Vitatron
Information provided by:	Medtronic - Vitatron
ClinicalTrials.gov Identifier:	NCT00156741