MedTrace Logo

Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III

NCT00617175 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1902

Last updated 2025-07-02

Study results available
· View outcomes & findings →

Summary

To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.

Conditions

Interventions

DEVICE

Implantable Defibrillator

Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia

DEVICE

Implantable Defibrillator

number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Jorg O. Schwab, MD · University of Bonn, Bonn, Germany

  • Maurizio Gasparini, MD · Humanitas Hospital, Milano Italy

  • Maurizio Lunati, MD · Niguarda Hospital, Milano, Italy

  • Bernd Lemke, MD · Klinikum Lüdenscheid, Lüdenscheid, Germany

  • João Sousa, MD · H. Santa Maria - Lisbon - Portugal

  • Andrzej Okreglicki, MD · University of Cape Town, Cape Town, South Africa

  • Angel Arenal, MD · Hospital Gregorio Marañón, Madrid, Spain

  • Maurits Wijffels, MD · St. Antonius hospital - NIEUWEGEIN, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Saudi Arabia
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT00617175 on ClinicalTrials.gov