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X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure

NCT00157846 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-07-03

No results posted yet for this study

Summary

The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation (more than 80%); are eligible for the exchange of an old pacemaker or implantable cardioverter defibrillator (ICD); and have ventricular dysfunction (left ventricular ejection fraction \[LVEF\] \< 35%). All patients eligible for participation in the study will be upgraded with a cardiac resynchronization therapy (CRT)-device and receive either right ventricular or biventricular stimulation in a crossover protocol. The endpoint is functional performance measured by spiroergometry.

Conditions

  • Heart Failure, Congestive

Interventions

DEVICE

CRT-P or CRT-D Device

Upgrade from ICD or pacemaker to CRT-D/CRT-P (Insync III, Insync Marquis, Insync Sentry, Insync Maximo, Concerto)

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Thomas Lawo, MD · Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT00157846 on ClinicalTrials.gov