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Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224341
Recruitment Status : Unknown
Verified September 2005 by Vitatron France.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : October 18, 2006
Sponsor:
Information provided by:
Vitatron France

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.

Condition or disease Intervention/treatment Phase
Sick Sinus Syndrome Brady-Tachy Syndrome Device: Pacemaker Vitatron Selection 9000 Device: Pacemaker Vitatron T70 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Study Start Date : November 2003
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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
  2. In a configuration including all the preventive pacing therapies of the device
  3. The primary endpoint is the atrial fibrillation burden.

Secondary Outcome Measures :
  1. 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
  2. Nb of cardioversions
  3. Symptom score
  4. Restarts
  5. Daily incidence of AF
  6. Mean sinus rhythm duration
  7. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224341


Contacts
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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
Show Show 37 study locations
Sponsors and Collaborators
Vitatron France
Investigators
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Principal Investigator: Patrick Attuel, MD CNOM

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.
Fuster V, Rydén LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Lévy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG; American College of Cardiology; American Heart Association; European Society of Cardiology; North American Society of Pacing and Electrophysiology. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to develop guidelines for the management of patients with atrial fibrillation) developed in collaboration with the North American Society of Pacing and Electrophysiology. Eur Heart J. 2001 Oct;22(20):1852-923.
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).
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).

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ClinicalTrials.gov Identifier: NCT00224341    
Other Study ID Numbers: ARREST-AF
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 18, 2006
Last Verified: September 2005
Keywords provided by Vitatron France:
Pacemaker
Atrial Fibrillation
Prevention pacing
Algorithms
Sick sinus syndrome + Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Sick Sinus Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Arrhythmia, Sinus
Heart Block
Cardiac Conduction System Disease