Back to resultsArrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
Primary Purpose
Sick Sinus Syndrome, Brady-Tachy Syndrome
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Pacemaker Vitatron Selection 9000
Pacemaker Vitatron T70
Sponsored by
About this trial
This is an interventional prevention trial for Sick Sinus Syndrome focused on measuring Pacemaker, Atrial Fibrillation, Prevention pacing, Algorithms, Sick sinus syndrome + Atrial Fibrillation
Eligibility 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
Sites / Locations
- CHGRecruiting
- Hopital PrivéRecruiting
- CHRecruiting
- CHRecruiting
- Clinique de Bordeaux CauderanRecruiting
- CHURecruiting
- CHRecruiting
- HIA PercyRecruiting
- CH
- CH René PlevenRecruiting
- CHRecruiting
- CHRecruiting
- CHRecruiting
- CHRecruiting
- CMC Parly IIRecruiting
- CHRecruiting
- CHRecruiting
- CH Saint PhilibertRecruiting
- Clinique de la CasamanceRecruiting
- Clinique BouchardRecruiting
- CHU La TimoneRecruiting
- CHRecruiting
- CHRecruiting
- CHURecruiting
- CHRecruiting
- Clinique Ambroise ParéRecruiting
- Hopital Cardiologique du Haut LevequeRecruiting
- Hopital Privé Claude GalienRecruiting
- Polyclinique Saint LaurentRecruiting
- CHURecruiting
- CHURecruiting
- CHURecruiting
- Institut Arnalt TzanckRecruiting
- CMCORecruiting
- CHRecruiting
- CH ToulonRecruiting
- CHRecruiting
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00224341
Brief Title
Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Vitatron France
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome, Brady-Tachy Syndrome
Keywords
Pacemaker, Atrial Fibrillation, Prevention pacing, Algorithms, Sick sinus syndrome + Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
360 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Pacemaker Vitatron Selection 9000
Intervention Type
Device
Intervention Name(s)
Pacemaker Vitatron T70
Primary Outcome Measure Information:
Title
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
Title
In a configuration including all the preventive pacing therapies of the device
Title
The primary endpoint is the atrial fibrillation burden.
Secondary Outcome Measure Information:
Title
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
Title
Nb of cardioversions
Title
Symptom score
Title
Restarts
Title
Daily incidence of AF
Title
Mean sinus rhythm duration
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christèle Pelade, Engineer
Phone
01 53 98 83 00
Email
christele.pelade@vitatron.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bérangère Leroy, Engineer
Phone
01 53 98 83 00
Email
berangere.leroy@vitatron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Attuel, MD
Organizational Affiliation
CNOM
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHG
City
Abbeville
ZIP/Postal Code
80100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Ernst Poulard, MD
Phone
+33 322255200
First Name & Middle Initial & Last Name & Degree
Jean-Ernst Poulard, MD
Facility Name
Hopital Privé
City
Antony
ZIP/Postal Code
92160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier Gedin, MD
Phone
+33 146743700
First Name & Middle Initial & Last Name & Degree
Didier Gedin, MD
First Name & Middle Initial & Last Name & Degree
Cyrus Moini, MD
Facility Name
CH
City
Auxerre
ZIP/Postal Code
89011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François-Xavier Soto, MD
Phone
+33 386484658
First Name & Middle Initial & Last Name & Degree
François-Xavier Soto, MD
First Name & Middle Initial & Last Name & Degree
Stéphane Mourot, MD
Facility Name
CH
City
Avignon
ZIP/Postal Code
84902
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Faugier, MD
Phone
+33 432753141
First Name & Middle Initial & Last Name & Degree
Jean-Paul Faugier, MD
Facility Name
Clinique de Bordeaux Cauderan
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Gencel, MD
First Name & Middle Initial & Last Name & Degree
Laurent Gencel, MD
Facility Name
CHU
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice Scanu, MD
Phone
+33 231063106
First Name & Middle Initial & Last Name & Degree
Patrice Scanu, MD
Facility Name
CH
City
Castres
ZIP/Postal Code
81108
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Chavernac, MD
Phone
+33 563716328
First Name & Middle Initial & Last Name & Degree
Pascal Chavernac, MD
Facility Name
HIA Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Plotton, MD
Phone
+33 141466241
First Name & Middle Initial & Last Name & Degree
Christian Plotton, MD
Facility Name
CH
City
Colmar
ZIP/Postal Code
68024
Country
France
Individual Site Status
Completed
Facility Name
CH René Pleven
City
Dinan
ZIP/Postal Code
22101
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Bazin, MD
Phone
+33 296857250
First Name & Middle Initial & Last Name & Degree
Patrick Bazin, MD
Facility Name
CH
City
Dole
ZIP/Postal Code
39108
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugues Zimmermann, MD
Phone
+33 384798065
First Name & Middle Initial & Last Name & Degree
Hugues Zimmermann, MD
Facility Name
CH
City
Dunkerque
ZIP/Postal Code
59240
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Charles Aisenfarb, MD
Phone
+33 328285623
First Name & Middle Initial & Last Name & Degree
Jean-Charles Aisenfarb, MD
Facility Name
CH
City
Evreux
ZIP/Postal Code
27000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bouchaib Deriouich, MD
First Name & Middle Initial & Last Name & Degree
Bouchaib Deriouich, MD
Facility Name
CH
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Defaye, MD
Phone
+33 476765507
First Name & Middle Initial & Last Name & Degree
Pascal Defaye, MD
Facility Name
CMC Parly II
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Attuel, MD
Phone
+33 139637000
First Name & Middle Initial & Last Name & Degree
Patrick Attuel, MD
Facility Name
CH
City
Le Havre
ZIP/Postal Code
76083
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Cheradame, MD
Phone
+33 232733155
First Name & Middle Initial & Last Name & Degree
Isabelle Cheradame, MD
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Favier, MD
Facility Name
CH
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe D'Ivernois, MD
Phone
+33 555056310
First Name & Middle Initial & Last Name & Degree
Christophe D'Ivernois, MD
Facility Name
CH Saint Philibert
City
Lomme
ZIP/Postal Code
59160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Graux, MD
Phone
+33 320225058
First Name & Middle Initial & Last Name & Degree
Pierre Graux, MD
Facility Name
Clinique de la Casamance
City
Marseille
ZIP/Postal Code
13000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Faure, MD
First Name & Middle Initial & Last Name & Degree
Jacques Faure, MD
Facility Name
Clinique Bouchard
City
Marseille
ZIP/Postal Code
13006
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime Guenoun, MD
Phone
+33 491159062
First Name & Middle Initial & Last Name & Degree
Maxime Guenoun, MD
First Name & Middle Initial & Last Name & Degree
Olivier Roux, MD
Facility Name
CHU La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Claude Deharo, Pr
Phone
+33 491386575
First Name & Middle Initial & Last Name & Degree
Jean-Claude Deharo, Pr
Facility Name
CH
City
Martigues
ZIP/Postal Code
136995
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André Ebagosti, MD
Phone
+33 442432540
First Name & Middle Initial & Last Name & Degree
André Ebagosti, MD
Facility Name
CH
City
Metz
ZIP/Postal Code
57000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Boursier, MD
Phone
+33 387553231
First Name & Middle Initial & Last Name & Degree
Michel Boursier, MD
Facility Name
CHU
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Davy, Pr
Phone
+33 467336164
First Name & Middle Initial & Last Name & Degree
Jean-Marc Davy, Pr
First Name & Middle Initial & Last Name & Degree
Jean-Luc Pasquié, MD
First Name & Middle Initial & Last Name & Degree
Franck Raczka, MD
Facility Name
CH
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Levy, MD
Phone
+33 389647120
First Name & Middle Initial & Last Name & Degree
Jacques Levy, MD
Facility Name
Clinique Ambroise Paré
City
Neuilly sur Seine
ZIP/Postal Code
92200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Thomas, MD
Phone
+33 146418965
First Name & Middle Initial & Last Name & Degree
Olivier Thomas, MD
Facility Name
Hopital Cardiologique du Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Clementy, Pr
Phone
+33 557656471
First Name & Middle Initial & Last Name & Degree
Jacques Clementy, Pr
First Name & Middle Initial & Last Name & Degree
Sylvain Reuter, MD
Facility Name
Hopital Privé Claude Galien
City
Quincy-sous-Sénart
ZIP/Postal Code
91480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Bleinc, MD
Phone
+33 169399132
First Name & Middle Initial & Last Name & Degree
Dominique Bleinc, MD
Facility Name
Polyclinique Saint Laurent
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Baisset, MD
First Name & Middle Initial & Last Name & Degree
Jean-Michel Baisset, MD
Facility Name
CHU
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Mabo, Pr
Phone
+33 299282527
First Name & Middle Initial & Last Name & Degree
Philippe Mabo, Pr
Facility Name
CHU
City
Rouen
ZIP/Postal Code
76035
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Anselme, MD
Phone
+33 232888111
First Name & Middle Initial & Last Name & Degree
Frédéric Anselme, MD
First Name & Middle Initial & Last Name & Degree
Arnaud Savoure, MD
Facility Name
CHU
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Da Costa, MD
Phone
+33 477828340
First Name & Middle Initial & Last Name & Degree
Antoine Da Costa, MD
Facility Name
Institut Arnalt Tzanck
City
Saint Laurent du Var
ZIP/Postal Code
06721
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude Mariottini, MD
Phone
++33 4 92 27 37 27
First Name & Middle Initial & Last Name & Degree
Claude Mariottini, MD
First Name & Middle Initial & Last Name & Degree
Philippe Durand, MD
Facility Name
CMCO
City
Schiltigheim
ZIP/Postal Code
67303
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Philippot, MD
Phone
+33 3 88628318
First Name & Middle Initial & Last Name & Degree
François Philippot, MD
Facility Name
CH
City
Thionville
ZIP/Postal Code
57100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Yves Thisse, MD
Phone
+33 382558300
First Name & Middle Initial & Last Name & Degree
Jean-Yves Thisse, MD
First Name & Middle Initial & Last Name & Degree
Philippe Houplon, MD
Facility Name
CH Toulon
City
Toulon
ZIP/Postal Code
83056
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Canavy, MD
Phone
+33 494616069
First Name & Middle Initial & Last Name & Degree
Isabelle Canavy, MD
First Name & Middle Initial & Last Name & Degree
Alex Baralla, MD
First Name & Middle Initial & Last Name & Degree
Jean Julienne, MD
Facility Name
CH
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benaissa Agraou, MD
Phone
+33 327143041
First Name & Middle Initial & Last Name & Degree
Benaissa Agraou, MD
12. IPD Sharing Statement
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Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
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