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NCT00729703 · ClinicalTrials.gov registry record · Phase 4
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
A Phase 4 study of Tachycardia, sponsored by LivaNova.
- Completed
- Registry status
- Phase 4
- Development phase
- 462
- Enrollment target
- 20
- Study locations
NCT00729703: Completed Phase 4 study of Tachycardia, sponsored by LivaNova.
NCT00729703 is a Phase 4 study of Tachycardia that has completed, run by LivaNova. The registered enrollment target is 462 participants, below the 841-participant average among 8 other Tachycardia trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00729703, a Phase 4 study of Tachycardia, has completed, sponsored by LivaNova.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 462 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.
Conditions Studied
Interventions
- DEVICE Ovatio DR 6550
- DEVICE OVATIO DR 6550
Study Locations (20)
Other
- Algemeen Ziekenhuis - Antwepen - Antwepen
- Kliniek Maria Middelares - Gent - Ghent
- Heart Center Virga Jesse Ziekenhuis - Hasselt - Hasselt
- CHUM Hotel-Dieu - Montreal
- Hôpital Sacré Coeur - Montreal
- Centre Hospitalier General - Aix-en-Provence
- CHU Le Haut L'Evêque - Bordeaux
- CHU Hôpital Michallon Grenoble - Grenoble
- Clinique De Parly II - Le Chesnay
- Clinique les sources - Le Mans
- CH ST Philibert - Lomme
- Hôpital St Joseph - Lyon
- Hopital Arnaud De Villeneuve - Montpellier
- CHU Nantes - Nantes
- Clinique Bizet - Paris
Georgia
- Piedmont Hospital Research Institute - Atlanta
- Atlanta Va Medical Center - Decatur
Louisiana
- Southern Medical Research, Llc - Mandeville
Ohio
- River City Cardiology - Jeffersonville
South Carolina
- Pee Dee Cardiology - Florence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2006-06 |
| Est. Completion | 2013-10 |
| Phase | Phase 4 |
What the finished NCT00729703 record still lists
NCT00729703 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, below the 841-participant average among 8 other Tachycardia trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Tachycardia appearing as the primary indexed condition, and to 2 interventions - of which Ovatio DR 6550 is the first listed.
NCT00729703 names 20 study sites across 5 states, led by Other, Georgia, Louisiana.
Frequently Asked Questions
What is clinical trial NCT00729703 about?
NCT00729703 is a clinical study titled "Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications". This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients w...
What is the current status of trial NCT00729703?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 462 participants. The study started on 2006-06. Estimated completion is 2013-10.
What conditions does trial NCT00729703 study?
This clinical trial studies the following conditions: Tachycardia.
What interventions are being tested in trial NCT00729703?
The interventions under investigation include: Ovatio DR 6550 (DEVICE), OVATIO DR 6550 (DEVICE).
Who is sponsoring clinical trial NCT00729703?
This trial is sponsored by LivaNova, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00729703 being conducted?
This trial has 20 study locations across Georgia, Louisiana, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00729703's enrollment target sits among peer trials
462 5th of 8 higher than 4 of 8 other Tachycardia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tachycardia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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