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Sick Sinus SyndromePhase 4NCT00161551

Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

A Phase 4 study testing Vitatron T70 DR in people with Sick Sinus Syndrome, run by Medtronic BRC at 5 sites in Germany.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel algorithm to minimize ventricular pacing). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sick Sinus Syndrome
What is being tested?
Vitatron T70 DR
Type of treatment
Medical device
How many people
402 participants
Where
5 sitesGermany
Study dates
Nov 2004to Dec 2010
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

  • Symptomatic sinus bradycardia, Sinusarrest
  • Symptomatic SA block
  • Bradycardia-Tachycardia-Syndrome
  • Binodal diseases

Who cannot join

  • 1st degree AV Block
  • 2nd degree AV block
  • 3rd degree AV block
  • Total right bundle branch block
  • Indication for biventricular stimulation
  • Inter atrial conduction delays (P-wave > 150MS)
Show all 21Show fewer
  • Permanent or therapy refractory Atrial Fibrillation
  • Heart Failure acc. NYHA III or IV
  • Myocardial Infarction less than 6 months before pacemaker implant
  • Hypertrophic obstructive cardiomyopathy
  • Symptomatic hypo- or hyperthyreosis
  • Cardiogenic shock
  • Pregnancy
  • Lactation period
  • Unstable angina pectoris
  • Poorly controlled Diabetes mellitus
  • Neuromuscular diseases
  • Patients under 18 years of age
  • Patients involved in other studies
  • Reduced expectancy of life due to other diseases
  • Patients who cannot attend follow-up visits regularly

Trial locations and contacts

5 sites in 1 country.

Matthias Reimers, Dipl. Documentalist contact

+49 21152930

Matthias.reimers@vitatron.com

Steffen Gazarek, Dr., Engineer contact

+49 1729135662

steffen.gazarek@vitatron.com

5 sites in 1 country

Germany5 sites, 5 recruiting

  • Klinikum Coburg

    Coburg, 96450

    V. Schibgilla, MD, +49 9561220 ext. 6348, v.schibgilla@t-online.de

    V. Schibgilla, MD

    Recruiting

  • Universitätskrankenhaus Eppendorf

    Hamburg, 20251

    A. Schuchert, MD, +49 40428030 ext. 5765, schuchert@uke.uni-hamburg.de

    A. Schuchert, MD

    Recruiting

  • Kardiologische Gemeinschaftspraxis

    Papenburg, 26871

    A. Wilke, MD, +49 4961992013, Praxis@Kardiologie-Papenburg.de

    A. Wilke, MD

    Recruiting

  • Kardiologische Praxis

    Starnberg-Percha, 82319

    A. Frey, MD, +49 8151559055, kardiologie-sta@t-online.de

    A. Frey, MD

    Recruiting

  • Sophien- und Hufelandklinikum GmbH

    Weimar, 99425

    E. Ebner, PD MD, +49 3643571100, innere1@klinikum-weimar.de

    E. Ebner, PD MD

    Recruiting

Other trials in Germany

About this study

Official title: A Randomized, Prospective Multicenter Study to Determine the Incidence of Atrial Fibrillation and Heart Failure in Correlation to Stimulation Modes of Pacemakers

The purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel algorithm to minimize ventricular pacing).

Read the detailed description

Background: Dual-chamber pacemaker therapy has become the mainstay for treating symptomatic sick sinus syndrome (SSS). This approach aims to results in a physiologic conduction pattern, while protecting against atrioventricular conduction anomalies. Smaller studies and subgroup analyses of larger trials suggest that ventricular stimulation associated with this treatment has adverse effects, especially an increased incidence of atrial fibrillation and heart failure.

Methods: In MODEST, a study on patients with sick sinus syndrome who have an indication for pacing therapy, atrial pacing (AAI) is compared with dual-chamber pacing (DDD) combined with a novel algorithm developed to lower the number of ventricularly paced beats. The study aims to assess the impact of ventricular pacing on the development of atrial arrhythmias and to test the hypothesis that DDD pacing using the algorithm is associated with a higher rate of atrial arrhythmias as atrial pacing. Included will be patients with SSS and no high degree AV node disease except for patients with first-degree AV block ≤300ms. Patients will be followed stratified by their Wenckebach point (≥ 120 bpm versus < 120 bpm).

Conclusion: MODEST is a large, prospective, randomized, multicenter trial aiming to compare a novel type of dual-chamber pacing approach (that includes an algorithm designed to lower the number of ventricularly paced beats) with pure atrial pacing, assessing the impact on the incidence of atrial arrhythmias in patients with sick sinus syndrome.

Being tested
Vitatron T70 DR
Keywords
Cardiac Pacing, artificial, Atrial Fibrillation, Heart Failure, Pacemaker leads, Pacing Mode
Medical subject headings
Sick Sinus Syndrome, Atrial Fibrillation, Heart Failure

What participants receive

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

  • Vitatron T70 DRDevice

What is being measured

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

  1. Primary objective is to assess how the pacing mode affects the incidence of atrial fibrillation (AF) in patients with sick sinus syndrome. Since there are no data on the safety of AAI pacing in patients with Wenckebach points < 120 bpm and accor

Secondary outcomes (15)

  1. Number of patients with atrial fibrillation or heart failure > NYHA II

  2. AF burden

  3. Symptomatic atrial fibrillation

  4. Time period to first recurrence of AF

  5. Number of patients without recurrence of AF

  6. Mean duration of sinus rhythm

  7. Course of Wenckebach point

  8. Second- and third-degree AV block

  9. Reprogramming from AAI to DDD

  10. Fraction of atrial versus ventricular pacing

  11. Safety of treatment, complications

  12. Number of cardioversions

  13. Patients with persistent atrial fibrillation (AF >48h)

  14. Patients with permanent atrial fibrillation (AF throughout the follow-up period)

  15. Hospital admissions for cardiac reasons

Timeline

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

  1. First posted12 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Study completionDec 2010

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
Parallel groups
Masking
None (open label)
Enrolment
402 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00161551
Sponsor's protocol ID
MODEST V.2.2.1
Status last verified
Oct 2006
First submitted
9 Sep 2005
Last updated
2 Aug 2011
Results posted
No

Publications

  • Lamas GA, Orav EJ, Stambler BS, Ellenbogen KA, Sgarbossa EB, Huang SK, Marinchak RA, Estes NA 3rd, Mitchell GF, Lieberman EH, Mangione CM, Goldman L. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. 1998 Apr 16;338(16):1097-104. doi: 10.1056/NEJM199804163381602.

    PubMed 9545357

  • Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.

    PubMed 12063369

  • 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

  • Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. 2003 Aug 20;42(4):614-23. doi: 10.1016/s0735-1097(03)00757-5.

    PubMed 12932590

  • 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

  • Mattioli AV, Vivoli D, Mattioli G. Influence of pacing modalities on the incidence of atrial fibrillation in patients without prior atrial fibrillation. A prospective study. Eur Heart J. 1998 Feb;19(2):282-6. doi: 10.1053/euhj.1997.0616.

    PubMed 9519322

  • Kerr CR, Connolly SJ, Abdollah H, Roberts RS, Gent M, Yusuf S, Gillis AM, Tang AS, Talajic M, Klein GJ, Newman DM. Canadian Trial of Physiological Pacing: Effects of physiological pacing during long-term follow-up. Circulation. 2004 Jan 27;109(3):357-62. doi: 10.1161/01.CIR.0000109490.72104.EE. Epub 2004 Jan 5.

    PubMed 14707022

  • Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23. doi: 10.1001/jama.288.24.3115.

    PubMed 12495391

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitatron T70 DR in people with Sick Sinus Syndrome, run by Medtronic BRC at 5 sites in Germany.

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 21 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 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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 Matthias Reimers, Dipl. Documentalist (+49 21152930, Matthias.reimers@vitatron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary objective is to assess how the pacing mode affects the incidence of atrial fibrillation (AF) in patients with sick sinus syndrome. Since there are no data on the safety of AAI pacing in patients with Wenckebach points < 120 bpm and accor. 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 NCT00161551, which also lists 8 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 2 Aug 2011.

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