Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
NCT ID: NCT00224341
Last Updated: 2006-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
360 participants
INTERVENTIONAL
2003-11-30
2006-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Interventions
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Pacemaker Vitatron Selection 9000
Pacemaker Vitatron T70
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Vitatron France
INDUSTRY
Principal Investigators
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Patrick Attuel, MD
Role: PRINCIPAL_INVESTIGATOR
CNOM
Locations
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CHG
Abbeville, , France
Hopital Privé
Antony, , France
CH
Auxerre, , France
CH
Avignon, , France
Clinique de Bordeaux Cauderan
Bordeaux, , France
CHU
Caen, , France
CH
Castres, , France
HIA Percy
Clamart, , France
CH
Colmar, , France
CH René Pleven
Dinan, , France
CH
Dole, , France
CH
Dunkirk, , France
CH
Évreux, , France
CH
Grenoble, , France
CMC Parly II
Le Chesnay, , France
CH
Le Havre, , France
CH
Limoges, , France
CH Saint Philibert
Lomme, , France
Clinique de la Casamance
Marseille, , France
Clinique Bouchard
Marseille, , France
CHU La Timone
Marseille, , France
CH
Martigues, , France
CH
Metz, , France
CHU
Montpellier, , France
CH
Mulhouse, , France
Clinique Ambroise Paré
Neuilly-sur-Seine, , France
Hopital Cardiologique du Haut Leveque
Pessac, , France
Hopital Privé Claude Galien
Quincy-sous-Sénart, , France
Polyclinique Saint Laurent
Rennes, , France
CHU
Rennes, , France
CHU
Rouen, , France
CHU
Saint-Etienne, , France
Institut Arnalt Tzanck
Saint-Laurent-du-Var, , France
CMCO
Schiltigheim, , France
CH
Thionville, , France
CH Toulon
Toulon, , France
CH
Valenciennes, , France
Countries
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Central Contacts
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Facility Contacts
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Jean-Ernst Poulard, MD
Role: primary
Didier Gedin, MD
Role: primary
François-Xavier Soto, MD
Role: primary
Jean-Paul Faugier, MD
Role: primary
Laurent Gencel, MD
Role: primary
Patrice Scanu, MD
Role: primary
Pascal Chavernac, MD
Role: primary
Christian Plotton, MD
Role: primary
Patrick Bazin, MD
Role: primary
Hugues Zimmermann, MD
Role: primary
Jean-Charles Aisenfarb, MD
Role: primary
Bouchaib Deriouich, MD
Role: primary
Pascal Defaye, MD
Role: primary
Patrick Attuel, MD
Role: primary
Isabelle Cheradame, MD
Role: primary
Christophe D'Ivernois, MD
Role: primary
Pierre Graux, MD
Role: primary
Jacques Faure, MD
Role: primary
Maxime Guenoun, MD
Role: primary
Jean-Claude Deharo, Pr
Role: primary
André Ebagosti, MD
Role: primary
Michel Boursier, MD
Role: primary
Jean-Marc Davy, Pr
Role: primary
Jacques Levy, MD
Role: primary
Olivier Thomas, MD
Role: primary
Jacques Clementy, Pr
Role: primary
Dominique Bleinc, MD
Role: primary
Jean-Michel Baisset, MD
Role: primary
Philippe Mabo, Pr
Role: primary
Frédéric Anselme, MD
Role: primary
Antoine Da Costa, MD
Role: primary
Claude Mariottini, MD
Role: primary
François Philippot, MD
Role: primary
Jean-Yves Thisse, MD
Role: primary
Isabelle Canavy, MD
Role: primary
Benaissa Agraou, MD
Role: primary
References
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Fauchier L, Briand F, Soto FX, Quennelle F, Levy J, Darmon JP, Lellouche D, Lavergne T, Poret P, Pelade C, Babuty D. Management of atrial tachyarrhythmias: benefits of pacemaker diagnostics. Pacing Clin Electrophysiol. 2003 Jan;26(1P2):233-8. doi: 10.1046/j.1460-9592.2003.00023.x.
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, Ryden LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Levy 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. doi: 10.1053/euhj.2001.2983. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Daoud EG, Weiss R, Bahu M, Knight BP, Bogun F, Goyal R, Harvey M, Strickberger SA, Man KC, Morady F. Effect of an irregular ventricular rhythm on cardiac output. Am J Cardiol. 1996 Dec 15;78(12):1433-6. doi: 10.1016/s0002-9149(97)89297-1.
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).
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.
Jenkins LS, Bubien RS. Quality of life in patients with atrial fibrillation. Cardiol Clin. 1996 Nov;14(4):597-606. doi: 10.1016/s0733-8651(05)70307-6.
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).
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.
Other Identifiers
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ARREST-AF
Identifier Type: -
Identifier Source: org_study_id