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Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Vitatron France.   Recruitment status was  Recruiting

First Received on September 20, 2005.   Last Updated on October 17, 2006   History of Changes
Sponsor: 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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Arrhythmia Atrial Fibrillation
U.S. FDA Resources

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
CHG Recruiting
Abbeville, France, 80100
Contact: Jean-Ernst Poulard, MD     +33 322255200        
Principal Investigator: Jean-Ernst Poulard, MD            
Hopital Privé Recruiting
Antony, France, 92160
Contact: Didier Gedin, MD     +33 146743700        
Principal Investigator: Didier Gedin, MD            
Sub-Investigator: Cyrus Moini, MD            
CH Recruiting
Auxerre, France, 89011
Contact: François-Xavier Soto, MD     +33 386484658        
Principal Investigator: François-Xavier Soto, MD            
Sub-Investigator: Stéphane Mourot, MD            
CH Recruiting
Avignon, France, 84902
Contact: Jean-Paul Faugier, MD     +33 432753141        
Principal Investigator: Jean-Paul Faugier, MD            
Clinique de Bordeaux Cauderan Recruiting
Bordeaux, France, 33300
Contact: Laurent Gencel, MD            
Principal Investigator: Laurent Gencel, MD            
CHU Recruiting
Caen, France, 14033
Contact: Patrice Scanu, MD     +33 231063106        
Principal Investigator: Patrice Scanu, MD            
CH Recruiting
Castres, France, 81108
Contact: Pascal Chavernac, MD     +33 563716328        
Principal Investigator: Pascal Chavernac, MD            
HIA Percy Recruiting
Clamart, France, 92141
Contact: Christian Plotton, MD     +33 141466241        
Principal Investigator: Christian Plotton, MD            
CH Completed
Colmar, France, 68024
CH René Pleven Recruiting
Dinan, France, 22101
Contact: Patrick Bazin, MD     +33 296857250        
Principal Investigator: Patrick Bazin, MD            
CH Recruiting
Dole, France, 39108
Contact: Hugues Zimmermann, MD     +33 384798065        
Principal Investigator: Hugues Zimmermann, MD            
CH Recruiting
Dunkerque, France, 59240
Contact: Jean-Charles Aisenfarb, MD     +33 328285623        
Principal Investigator: Jean-Charles Aisenfarb, MD            
CH Recruiting
Evreux, France, 27000
Contact: Bouchaib Deriouich, MD            
Principal Investigator: Bouchaib Deriouich, MD            
CH Recruiting
Grenoble, France, 38043
Contact: Pascal Defaye, MD     +33 476765507        
Principal Investigator: Pascal Defaye, MD            
CMC Parly II Recruiting
Le Chesnay, France, 78150
Contact: Patrick Attuel, MD     +33 139637000        
Principal Investigator: Patrick Attuel, 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
Limoges, France, 87042
Contact: Christophe D'Ivernois, MD     +33 555056310        
Principal Investigator: Christophe D'Ivernois, MD            
CH Saint Philibert Recruiting
Lomme, France, 59160
Contact: Pierre Graux, MD     +33 320225058        
Principal Investigator: Pierre Graux, MD            
Clinique de la Casamance Recruiting
Marseille, France, 13000
Contact: Jacques Faure, MD            
Principal Investigator: Jacques Faure, MD            
CHU La Timone Recruiting
Marseille, France, 13385
Contact: Jean-Claude Deharo, Pr     +33 491386575        
Principal Investigator: Jean-Claude Deharo, Pr            
Clinique Bouchard Recruiting
Marseille, France, 13006
Contact: Maxime Guenoun, MD     +33 491159062        
Principal Investigator: Maxime Guenoun, MD            
Sub-Investigator: Olivier Roux, MD            
CH Recruiting
Martigues, France, 136995
Contact: André Ebagosti, MD     +33 442432540        
Principal Investigator: André Ebagosti, MD            
CH Recruiting
Metz, France, 57000
Contact: Michel Boursier, MD     +33 387553231        
Principal Investigator: Michel Boursier, 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
Mulhouse, France, 68051
Contact: Jacques Levy, MD     +33 389647120        
Principal Investigator: Jacques Levy, MD            
Clinique Ambroise Paré Recruiting
Neuilly sur Seine, France, 92200
Contact: Olivier Thomas, MD     +33 146418965        
Principal Investigator: Olivier Thomas, 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            
Hopital Privé Claude Galien Recruiting
Quincy-sous-Sénart, France, 91480
Contact: Dominique Bleinc, MD     +33 169399132        
Principal Investigator: Dominique Bleinc, MD            
CHU Recruiting
Rennes, France, 35033
Contact: Philippe Mabo, Pr     +33 299282527        
Principal Investigator: Philippe Mabo, Pr            
Polyclinique Saint Laurent Recruiting
Rennes, France, 35000
Contact: Jean-Michel Baisset, MD            
Principal Investigator: Jean-Michel Baisset, MD            
CHU Recruiting
Rouen, France, 76035
Contact: Frédéric Anselme, MD     +33 232888111        
Principal Investigator: Frédéric Anselme, MD            
Sub-Investigator: Arnaud Savoure, MD            
CHU Recruiting
Saint Etienne, France, 42055
Contact: Antoine Da Costa, MD     +33 477828340        
Principal Investigator: Antoine Da Costa, 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            
CMCO Recruiting
Schiltigheim, France, 67303
Contact: François Philippot, MD     +33 3 88628318        
Principal Investigator: François Philippot, 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 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            
CH Recruiting
Valenciennes, France, 59322
Contact: Benaissa Agraou, MD     +33 327143041        
Principal Investigator: Benaissa Agraou, 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.

ClinicalTrials.gov Identifier: NCT00224341     History of Changes
Other Study ID Numbers: ARREST-AF
Study First Received: September 20, 2005
Last Updated: October 17, 2006
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

Additional relevant MeSH terms:
Atrial Fibrillation
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block

ClinicalTrials.gov processed this record on May 21, 2012



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