Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

October 17, 2006 updated by: Vitatron France
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80100
        • Recruiting
        • CHG
        • Contact:
          • Jean-Ernst Poulard, MD
          • Phone Number: +33 322255200
        • Principal Investigator:
          • Jean-Ernst Poulard, MD
      • Antony, France, 92160
        • Recruiting
        • Hôpital Privé
        • Contact:
          • Didier Gedin, MD
          • Phone Number: +33 146743700
        • Principal Investigator:
          • Didier Gedin, MD
        • Sub-Investigator:
          • Cyrus Moini, MD
      • Auxerre, France, 89011
        • Recruiting
        • CH
        • Contact:
          • François-Xavier Soto, MD
          • Phone Number: +33 386484658
        • Principal Investigator:
          • François-Xavier Soto, MD
        • Sub-Investigator:
          • Stéphane Mourot, MD
      • Avignon, France, 84902
        • Recruiting
        • CH
        • Contact:
          • Jean-Paul Faugier, MD
          • Phone Number: +33 432753141
        • Principal Investigator:
          • Jean-Paul Faugier, MD
      • Bordeaux, France, 33300
        • Recruiting
        • Clinique de Bordeaux Cauderan
        • Contact:
          • Laurent Gencel, MD
        • Principal Investigator:
          • Laurent Gencel, MD
      • Caen, France, 14033
        • Recruiting
        • CHU
        • Contact:
          • Patrice Scanu, MD
          • Phone Number: +33 231063106
        • Principal Investigator:
          • Patrice Scanu, MD
      • Castres, France, 81108
        • Recruiting
        • CH
        • Contact:
          • Pascal Chavernac, MD
          • Phone Number: +33 563716328
        • Principal Investigator:
          • Pascal Chavernac, MD
      • Clamart, France, 92141
        • Recruiting
        • HIA Percy
        • Contact:
          • Christian Plotton, MD
          • Phone Number: +33 141466241
        • Principal Investigator:
          • Christian Plotton, MD
      • Colmar, France, 68024
        • Completed
        • CH
      • Dinan, France, 22101
        • Recruiting
        • CH René Pleven
        • Contact:
          • Patrick Bazin, MD
          • Phone Number: +33 296857250
        • Principal Investigator:
          • Patrick Bazin, MD
      • Dole, France, 39108
        • Recruiting
        • CH
        • Contact:
          • Hugues Zimmermann, MD
          • Phone Number: +33 384798065
        • Principal Investigator:
          • Hugues Zimmermann, MD
      • Dunkerque, France, 59240
        • Recruiting
        • CH
        • Contact:
          • Jean-Charles Aisenfarb, MD
          • Phone Number: +33 328285623
        • Principal Investigator:
          • Jean-Charles Aisenfarb, MD
      • Evreux, France, 27000
        • Recruiting
        • CH
        • Contact:
          • Bouchaib Deriouich, MD
        • Principal Investigator:
          • Bouchaib Deriouich, MD
      • Grenoble, France, 38043
        • Recruiting
        • CH
        • Contact:
          • Pascal Defaye, MD
          • Phone Number: +33 476765507
      • Le Chesnay, France, 78150
        • Recruiting
        • CMC Parly II
        • Contact:
          • Patrick Attuel, MD
          • Phone Number: +33 139637000
        • Principal Investigator:
          • Patrick Attuel, MD
      • Le Havre, France, 76083
        • Recruiting
        • CH
        • Contact:
          • Isabelle Cheradame, MD
          • Phone Number: +33 232733155
        • Principal Investigator:
          • Isabelle Cheradame, MD
        • Sub-Investigator:
          • Jean-Pierre Favier, MD
      • Limoges, France, 87042
        • Recruiting
        • CH
        • Contact:
          • Christophe D'Ivernois, MD
          • Phone Number: +33 555056310
        • Principal Investigator:
          • Christophe D'Ivernois, MD
      • Lomme, France, 59160
        • Recruiting
        • CH Saint Philibert
        • Contact:
          • Pierre Graux, MD
          • Phone Number: +33 320225058
        • Principal Investigator:
          • Pierre Graux, MD
      • Marseille, France, 13385
        • Recruiting
        • CHU La Timone
        • Contact:
          • Jean-Claude Deharo, Pr
          • Phone Number: +33 491386575
        • Principal Investigator:
          • Jean-Claude Deharo, Pr
      • Marseille, France, 13000
        • Recruiting
        • Clinique de la Casamance
        • Contact:
          • Jacques Faure, MD
        • Principal Investigator:
          • Jacques Faure, MD
      • Marseille, France, 13006
        • Recruiting
        • Clinique Bouchard
        • Contact:
          • Maxime Guenoun, MD
          • Phone Number: +33 491159062
        • Principal Investigator:
          • Maxime Guenoun, MD
        • Sub-Investigator:
          • Olivier Roux, MD
      • Martigues, France, 136995
        • Recruiting
        • CH
        • Contact:
          • André Ebagosti, MD
          • Phone Number: +33 442432540
        • Principal Investigator:
          • André Ebagosti, MD
      • Metz, France, 57000
        • Recruiting
        • CH
        • Contact:
          • Michel Boursier, MD
          • Phone Number: +33 387553231
        • Principal Investigator:
          • Michel Boursier, MD
      • Montpellier, France, 34295
        • Recruiting
        • CHU
        • Sub-Investigator:
          • Jean-Luc Pasquié, MD
        • Contact:
          • Jean-Marc Davy, Pr
          • Phone Number: +33 467336164
        • Principal Investigator:
          • Jean-Marc Davy, Pr
        • Sub-Investigator:
          • Franck Raczka, MD
      • Mulhouse, France, 68051
        • Recruiting
        • CH
        • Contact:
          • Jacques Levy, MD
          • Phone Number: +33 389647120
        • Principal Investigator:
          • Jacques Levy, MD
      • Neuilly sur Seine, France, 92200
        • Recruiting
        • Clinique Ambroise Pare
        • Contact:
          • Olivier Thomas, MD
          • Phone Number: +33 146418965
        • Principal Investigator:
          • Olivier Thomas, MD
      • Pessac, France, 33604
        • Recruiting
        • Hôpital Cardiologique du Haut Lévêque
        • Contact:
          • Jacques Clementy, Pr
          • Phone Number: +33 557656471
        • Principal Investigator:
          • Jacques Clementy, Pr
        • Sub-Investigator:
          • Sylvain Reuter, MD
      • Quincy-sous-Sénart, France, 91480
        • Recruiting
        • Hôpital Privé Claude Galien
        • Contact:
          • Dominique Bleinc, MD
          • Phone Number: +33 169399132
        • Principal Investigator:
          • Dominique Bleinc, MD
      • Rennes, France, 35000
        • Recruiting
        • Polyclinique Saint Laurent
        • Contact:
          • Jean-Michel Baisset, MD
        • Principal Investigator:
          • Jean-Michel Baisset, MD
      • Rennes, France, 35033
        • Recruiting
        • CHU
        • Contact:
          • Philippe Mabo, Pr
          • Phone Number: +33 299282527
        • Principal Investigator:
          • Philippe Mabo, Pr
      • Rouen, France, 76035
        • Recruiting
        • CHU
        • Principal Investigator:
          • Frédéric Anselme, MD
        • Contact:
          • Frédéric Anselme, MD
          • Phone Number: +33 232888111
        • Sub-Investigator:
          • Arnaud Savoure, MD
      • Saint Etienne, France, 42055
        • Recruiting
        • CHU
        • Contact:
          • Antoine Da Costa, MD
          • Phone Number: +33 477828340
        • Principal Investigator:
          • Antoine Da Costa, MD
      • Saint Laurent du Var, France, 06721
        • Recruiting
        • Institut Arnalt Tzanck
        • Contact:
          • Claude Mariottini, MD
          • Phone Number: ++33 4 92 27 37 27
        • Principal Investigator:
          • Claude Mariottini, MD
        • Sub-Investigator:
          • Philippe Durand, MD
      • Schiltigheim, France, 67303
        • Recruiting
        • CMCO
        • Contact:
          • François Philippot, MD
          • Phone Number: +33 3 88628318
        • Principal Investigator:
          • François Philippot, MD
      • Thionville, France, 57100
        • Recruiting
        • CH
        • Contact:
          • Jean-Yves Thisse, MD
          • Phone Number: +33 382558300
        • Principal Investigator:
          • Jean-Yves Thisse, MD
        • Sub-Investigator:
          • Philippe Houplon, MD
      • Toulon, France, 83056
        • Recruiting
        • CH Toulon
        • Contact:
          • Isabelle Canavy, MD
          • Phone Number: +33 494616069
        • Principal Investigator:
          • Isabelle Canavy, MD
        • Sub-Investigator:
          • Alex Baralla, MD
        • Sub-Investigator:
          • Jean Julienne, MD
      • Valenciennes, France, 59322
        • Recruiting
        • CH
        • Contact:
          • Benaissa Agraou, MD
          • Phone Number: +33 327143041
        • Principal Investigator:
          • Benaissa Agraou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitatron France

Investigators

  • Principal Investigator: Patrick Attuel, MD, CNOM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

October 18, 2006

Last Update Submitted That Met QC Criteria

October 17, 2006

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARREST-AF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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