Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161551
Recruitment Status : Unknown
Verified October 2006 by Medtronic BRC.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : August 2, 2011
Sponsor:
Collaborator:
Vitatron GmbH
Information provided by:
Medtronic BRC

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date August 2, 2011
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00161551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Number of patients with atrial fibrillation or heart failure > NYHA II
  • AF burden
  • Symptomatic atrial fibrillation
  • Time period to first recurrence of AF
  • Number of patients without recurrence of AF
  • Mean duration of sinus rhythm
  • Course of Wenckebach point
  • Second- and third-degree AV block
  • Reprogramming from AAI to DDD
  • Fraction of atrial versus ventricular pacing
  • Safety of treatment, complications
  • Number of cardioversions
  • Patients with persistent atrial fibrillation (AF >48h)
  • Patients with permanent atrial fibrillation (AF throughout the follow-up period)
  • Hospital admissions for cardiac reasons
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)
Official Title  ICMJE A Randomized, Prospective Multicenter Study to Determine the Incidence of Atrial Fibrillation and Heart Failure in Correlation to Stimulation Modes of Pacemakers
Brief 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Sick Sinus Syndrome
Intervention  ICMJE Device: Vitatron T70 DR
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 9, 2005)
402
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2010
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161551
Other Study ID Numbers  ICMJE MODEST V.2.2.1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medtronic BRC
Collaborators  ICMJE Vitatron GmbH
Investigators  ICMJE
Principal Investigator: Volker Schibgilla, MD
PRS Account Medtronic BRC
Verification Date October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP