Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

NCT00224341 | Unknown Phase 4

• 1 other identifier: ARREST-AF
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 37

Brief Summary

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.

Conditions

Sick Sinus Syndrome; Brady-Tachy Syndrome

Keywords

Pacemaker; Atrial Fibrillation; Prevention pacing; Algorithms; Sick sinus syndrome + Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Interventions

Pacemaker Vitatron Selection 9000 DEVICE

Pacemaker Vitatron T70 DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Permanent AF
• AF related to a reversible cause
• 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

Sponsors & Collaborators

• Vitatron France: lead

Study Sites (37)

CHG

Abbeville, 80100, France

RECRUITING

Hopital Privé

Antony, 92160, France

RECRUITING

CH

Auxerre, 89011, France

RECRUITING

CH

Avignon, 84902, France

RECRUITING

Clinique de Bordeaux Cauderan

Bordeaux, 33300, France

RECRUITING

CHU

Caen, 14033, France

RECRUITING

CH

Castres, 81108, France

RECRUITING

HIA Percy

Clamart, 92141, France

RECRUITING

CH

Colmar, 68024, France

COMPLETED

CH René Pleven

Dinan, 22101, France

RECRUITING

CH

Dole, 39108, France

RECRUITING

CH

Dunkirk, 59240, France

RECRUITING

CH

Évreux, 27000, France

RECRUITING

CH

Grenoble, 38043, France

RECRUITING

CMC Parly II

Le Chesnay, 78150, France

RECRUITING

CH

Le Havre, 76083, France

RECRUITING

CH

Limoges, 87042, France

RECRUITING

CH Saint Philibert

Lomme, 59160, France

RECRUITING

Clinique de la Casamance

Marseille, 13000, France

RECRUITING

Clinique Bouchard

Marseille, 13006, France

RECRUITING

CHU La Timone

Marseille, 13385, France

RECRUITING

CH

Martigues, 136995, France

RECRUITING

CH

Metz, 57000, France

RECRUITING

CHU

Montpellier, 34295, France

RECRUITING

CH

Mulhouse, 68051, France

RECRUITING

Clinique Ambroise Paré

Neuilly-sur-Seine, 92200, France

RECRUITING

Hopital Cardiologique du Haut Leveque

Pessac, 33604, France

RECRUITING

Hopital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

RECRUITING

Polyclinique Saint Laurent

Rennes, 35000, France

RECRUITING

CHU

Rennes, 35033, France

RECRUITING

CHU

Rouen, 76035, France

RECRUITING

CHU

Saint-Etienne, 42055, France

RECRUITING

Institut Arnalt Tzanck

Saint-Laurent-du-Var, 06721, France

RECRUITING

CMCO

Schiltigheim, 67303, France

RECRUITING

CH

Thionville, 57100, France

RECRUITING

CH Toulon

Toulon, 83056, France

RECRUITING

CH

Valenciennes, 59322, France

RECRUITING

Related Publications (29)

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  PMID: 12687819 BACKGROUND

• 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.

  BACKGROUND

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  PMID: 11601835 BACKGROUND

• 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. doi: 10.1136/hrt.82.3.319.

  PMID: 10455082 BACKGROUND

• Falk RH. Management of atrial fibrillation--radical reform or modest modification? N Engl J Med. 2002 Dec 5;347(23):1883-4. doi: 10.1056/NEJMe020137. No abstract available.

  PMID: 12466514 BACKGROUND

• 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. doi: 10.1056/NEJMoa021375.

  PMID: 12466507 BACKGROUND

• Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33. doi: 10.1056/NEJMoa021328.

  PMID: 12466506 BACKGROUND

• 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. doi: 10.1016/s0140-6736(00)03230-x.

  PMID: 11117910 BACKGROUND

• 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. doi: 10.1053/euhj.2001.2596. No abstract available.

  PMID: 11350085 BACKGROUND

• 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. doi: 10.1056/NEJM199809033391003.

  PMID: 9725923 BACKGROUND

• 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. doi: 10.1111/j.1540-8159.1998.tb01098.x.

  PMID: 9474682 BACKGROUND

• 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. doi: 10.1016/S0140-6736(97)03425-9.

  PMID: 9652562 BACKGROUND

• 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. doi: 10.1056/NEJM200005113421902.

  PMID: 10805823 BACKGROUND

• 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. doi: 10.1161/01.cir.102.7.736.

  PMID: 10942740 BACKGROUND

• Edvardson N. Efficacy of preventive pacing therapies in Paroxysmal Atrial Fibrillation - IV International meeting - Atrial Fibrillation 2001 : 161-164.

  BACKGROUND

• 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).

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1053/euhj.1999.1991.

  PMID: 10924300 BACKGROUND

• 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. doi: 10.1111/j.1540-8159.1999.tb00496.x.

  PMID: 10234708 BACKGROUND

• 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. doi: 10.1111/j.1540-8159.1998.tb00096.x.

  PMID: 9558685 BACKGROUND

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  PMID: 8970422 BACKGROUND

• 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)

  BACKGROUND

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  BACKGROUND

• 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. doi: 10.1016/s0735-1097(02)02528-7. No abstract available.

  PMID: 12427427 BACKGROUND

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  PMID: 8950060 BACKGROUND

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  BACKGROUND

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  BACKGROUND

• 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. doi: 10.1161/01.cir.94.7.1585.

  PMID: 8840848 BACKGROUND

MeSH Terms

Conditions

Sick Sinus Syndrome; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Attuel, MD

  CNOM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christèle Pelade, Engineer

CONTACT

01 53 98 83 00; christele.pelade@vitatron.com

Bérangère Leroy, Engineer

CONTACT

01 53 98 83 00; berangere.leroy@vitatron.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2003
• Study Completion: November 1, 2006
• Last Updated: October 18, 2006

Record last verified: 2005-09

Locations

FR (37)