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Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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

Locations
France
CHG
Abbeville, France, 80100
Hopital Privé
Antony, France, 92160
CH
Auxerre, France, 89011
CH
Avignon, France, 84902
Clinique de Bordeaux Cauderan
Bordeaux, France, 33300
CHU
Caen, France, 14033
CH
Castres, France, 81108
HIA Percy
Clamart, France, 92141
CH
Colmar, France, 68024
CH René Pleven
Dinan, France, 22101
CH
Dole, France, 39108
CH
Dunkerque, France, 59240
CH
Evreux, France, 27000
CH
Grenoble, France, 38043
CMC Parly II
Le Chesnay, France, 78150
CH
Le Havre, France, 76083
CH
Limoges, France, 87042
CH Saint Philibert
Lomme, France, 59160
Clinique de la Casamance
Marseille, France, 13000
Clinique Bouchard
Marseille, France, 13006
CHU La Timone
Marseille, France, 13385
CH
Martigues, France, 136995
CH
Metz, France, 57000
CHU
Montpellier, France, 34295
CH
Mulhouse, France, 68051
Clinique Ambroise Paré
Neuilly sur Seine, France, 92200
Hopital Cardiologique du Haut Leveque
Pessac, France, 33604
Hopital Privé Claude Galien
Quincy-sous-Sénart, France, 91480
Polyclinique Saint Laurent
Rennes, France, 35000
CHU
Rennes, France, 35033
CHU
Rouen, France, 76035
CHU
Saint Etienne, France, 42055
Institut Arnalt Tzanck
Saint Laurent du Var, France, 06721
CMCO
Schiltigheim, France, 67303
CH
Thionville, France, 57100
CH Toulon
Toulon, France, 83056
CH
Valenciennes, France, 59322
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.
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).

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:
Syndrome
Atrial Fibrillation
Sick Sinus Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Arrhythmia, Sinus
Heart Block

ClinicalTrials.gov processed this record on December 09, 2016