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
Sponsor:
Information provided by:
Vitatron France
ClinicalTrials.gov Identifier:
NCT00224341
First received: September 20, 2005
Last updated: October 17, 2006
Last verified: September 2005
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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.
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).
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).

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 August 27, 2014