Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 462 participants
Start Date 2006-06
Est. Completion 2013-10
Phase Phase 4

Sponsor

LivaNova

13 total trials

What the Registry Record Tells You About NCT00729703

The ClinicalTrials.gov registry entry for NCT00729703 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 462 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 841-participant average among 8 other Tachycardia trials with a reported enrollment target (45% lower). The listed sponsor is LivaNova, which has 13 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

Similar trials for Tachycardia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.