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Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications

NCT00729703 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2015-01-13

No results posted yet for this 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

  • Tachycardia

Interventions

DEVICE

Ovatio DR 6550

Dual-chamber ICD therapy with minimized ventricular pacing

DEVICE

OVATIO DR 6550

Single-chamber device therapy with settings which are common in clinical practice.

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • Kolb · Deutsches Herzzentrum München

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2011-12-31
Completion
2013-10-31

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00729703 on ClinicalTrials.gov