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AzTrials

Sick Sinus SyndromePhase 4NCT00224341

Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

A Phase 4 study testing Pacemaker Vitatron Selection 9000 and Pacemaker Vitatron T70 in people with Sick Sinus Syndrome and Brady-Tachy Syndrome, run by Vitatron France at 37 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sick Sinus Syndrome, Brady-Tachy Syndrome
What is being tested?
Pacemaker Vitatron Selection 9000 and Pacemaker Vitatron T70
Type of treatment
Medical device
How many people
360 participants
Where
37 sitesFrance
Study dates
Nov 2003to Nov 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

37 sites in 1 country.

Christèle Pelade, Engineer contact

01 53 98 83 00

christele.pelade@vitatron.com

Bérangère Leroy, Engineer contact

01 53 98 83 00

berangere.leroy@vitatron.com

37 sites in 1 country

France37 sites, 36 recruiting

  • CHG

    Abbeville, 80100

    Jean-Ernst Poulard, MD, +33 322255200

    Jean-Ernst Poulard, MD

    Recruiting

  • Hopital Privé

    Antony, 92160

    Didier Gedin, MD, +33 146743700

    Didier Gedin, MD

    Recruiting

  • CH

    Auxerre, 89011

    François-Xavier Soto, MD, +33 386484658

    François-Xavier Soto, MD

    Recruiting

  • CH

    Avignon, 84902

    Jean-Paul Faugier, MD, +33 432753141

    Jean-Paul Faugier, MD

    Recruiting

  • Clinique de Bordeaux Cauderan

    Bordeaux, 33300

    Laurent Gencel, MD

    Laurent Gencel, MD

    Recruiting

  • CHU

    Caen, 14033

    Patrice Scanu, MD, +33 231063106

    Patrice Scanu, MD

    Recruiting

  • CH

    Castres, 81108

    Pascal Chavernac, MD, +33 563716328

    Pascal Chavernac, MD

    Recruiting

  • HIA Percy

    Clamart, 92141

    Christian Plotton, MD, +33 141466241

    Christian Plotton, MD

    Recruiting

  • CH

    Colmar, 68024

    Completed

  • CH René Pleven

    Dinan, 22101

    Patrick Bazin, MD, +33 296857250

    Patrick Bazin, MD

    Recruiting

  • CH

    Dole, 39108

    Hugues Zimmermann, MD, +33 384798065

    Hugues Zimmermann, MD

    Recruiting

  • CH

    Dunkirk, 59240

    Jean-Charles Aisenfarb, MD, +33 328285623

    Jean-Charles Aisenfarb, MD

    Recruiting

  • CH

    Évreux, 27000

    Bouchaib Deriouich, MD

    Bouchaib Deriouich, MD

    Recruiting

  • CH

    Grenoble, 38043

    Pascal Defaye, MD, +33 476765507

    Pascal Defaye, MD

    Recruiting

  • CMC Parly II

    Le Chesnay, 78150

    Patrick Attuel, MD, +33 139637000

    Patrick Attuel, MD

    Recruiting

  • CH

    Le Havre, 76083

    Isabelle Cheradame, MD, +33 232733155

    Isabelle Cheradame, MD

    Recruiting

  • CH

    Limoges, 87042

    Christophe D'Ivernois, MD, +33 555056310

    Christophe D'Ivernois, MD

    Recruiting

  • CH Saint Philibert

    Lomme, 59160

    Pierre Graux, MD, +33 320225058

    Pierre Graux, MD

    Recruiting

  • Clinique de la Casamance

    Marseille, 13000

    Jacques Faure, MD

    Jacques Faure, MD

    Recruiting

  • Clinique Bouchard

    Marseille, 13006

    Maxime Guenoun, MD, +33 491159062

    Maxime Guenoun, MD

    Recruiting

  • CHU La Timone

    Marseille, 13385

    Jean-Claude Deharo, Pr, +33 491386575

    Jean-Claude Deharo, Pr

    Recruiting

  • CH

    Martigues, 136995

    André Ebagosti, MD, +33 442432540

    André Ebagosti, MD

    Recruiting

  • CH

    Metz, 57000

    Michel Boursier, MD, +33 387553231

    Michel Boursier, MD

    Recruiting

  • CHU

    Montpellier, 34295

    Jean-Marc Davy, Pr, +33 467336164

    Jean-Marc Davy, Pr

    Recruiting

  • CH

    Mulhouse, 68051

    Jacques Levy, MD, +33 389647120

    Jacques Levy, MD

    Recruiting

  • Clinique Ambroise Paré

    Neuilly-sur-Seine, 92200

    Olivier Thomas, MD, +33 146418965

    Olivier Thomas, MD

    Recruiting

  • Hopital Cardiologique du Haut Leveque

    Pessac, 33604

    Jacques Clementy, Pr, +33 557656471

    Jacques Clementy, Pr

    Recruiting

  • Hopital Privé Claude Galien

    Quincy-sous-Sénart, 91480

    Dominique Bleinc, MD, +33 169399132

    Dominique Bleinc, MD

    Recruiting

  • Polyclinique Saint Laurent

    Rennes, 35000

    Jean-Michel Baisset, MD

    Jean-Michel Baisset, MD

    Recruiting

  • CHU

    Rennes, 35033

    Philippe Mabo, Pr, +33 299282527

    Philippe Mabo, Pr

    Recruiting

  • CHU

    Rouen, 76035

    Frédéric Anselme, MD, +33 232888111

    Frédéric Anselme, MD

    Recruiting

  • CHU

    Saint-Etienne, 42055

    Antoine Da Costa, MD, +33 477828340

    Antoine Da Costa, MD

    Recruiting

  • Institut Arnalt Tzanck

    Saint-Laurent-du-Var, 06721

    Claude Mariottini, MD, ++33 4 92 27 37 27

    Claude Mariottini, MD

    Recruiting

  • CMCO

    Schiltigheim, 67303

    François Philippot, MD, +33 3 88628318

    François Philippot, MD

    Recruiting

  • CH

    Thionville, 57100

    Jean-Yves Thisse, MD, +33 382558300

    Jean-Yves Thisse, MD

    Recruiting

  • CH Toulon

    Toulon, 83056

    Isabelle Canavy, MD, +33 494616069

    Isabelle Canavy, MD

    Recruiting

  • CH

    Valenciennes, 59322

    Benaissa Agraou, MD, +33 327143041

    Benaissa Agraou, MD

    Recruiting

Other trials in France

About this study

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.

Read the 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.

Being tested
Pacemaker Vitatron Selection 9000, Pacemaker Vitatron T70
Keywords
Pacemaker, Atrial Fibrillation, Prevention pacing, Algorithms, Sick sinus syndrome + Atrial Fibrillation
Medical subject headings
Sick Sinus Syndrome, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pacemaker Vitatron Selection 9000Device

  • Pacemaker Vitatron T70Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 outcomes (7)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startNov 2003
  3. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Enrolment
360 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00224341
Sponsor's protocol ID
ARREST-AF
Status last verified
Sep 2005
First submitted
20 Sep 2005
Last updated
18 Oct 2006
Results posted
No

Publications

  • 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.

    PubMed 12687819

  • 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.

    PubMed 11601835

  • 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.

    PubMed 10455082

  • 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.

    PubMed 12466514

  • 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.

    PubMed 12466507

  • 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.

    PubMed 12466506

  • 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.

    PubMed 11117910

  • 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.

    PubMed 11350085

  • 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.

    PubMed 9725923

  • 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.

    PubMed 9474682

  • 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.

    PubMed 9652562

  • 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.

    PubMed 10805823

  • 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.

    PubMed 10942740

  • Edvardson N. Efficacy of preventive pacing therapies in Paroxysmal Atrial Fibrillation - IV International meeting - Atrial Fibrillation 2001 : 161-164.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pacemaker Vitatron Selection 9000 and Pacemaker Vitatron T70 in people with Sick Sinus Syndrome and Brady-Tachy Syndrome, run by Vitatron France at 37 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christèle Pelade, Engineer (01 53 98 83 00, christele.pelade@vitatron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary 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. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00224341, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2006.

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