Status:
UNKNOWN
Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)
Lead Sponsor:
Medtronic BRC
Collaborating Sponsors:
Vitatron GmbH
Conditions:
Sick Sinus Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 mini...
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 protecti...
Eligibility Criteria
Inclusion
- Symptomatic sinus bradycardia, Sinusarrest
- Symptomatic SA block
- Bradycardia-Tachycardia-Syndrome
- Binodal diseases
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00161551
Start Date
November 1 2004
End Date
December 1 2010
Last Update
August 2 2011
Active Locations (5)
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1
Klinikum Coburg
Coburg, Germany, 96450
2
Universitätskrankenhaus Eppendorf
Hamburg, Germany, 20251
3
Kardiologische Gemeinschaftspraxis
Papenburg, Germany, 26871
4
Kardiologische Praxis
Starnberg-Percha, Germany, 82319