TerminatedPhase 4

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

Stopped: Due to existing evidence eligible patients receive CRT treatment in first place

Germany36 participantsStarted 2003-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Implanted dual-chamber pacemaker or ICD system with replacement indication * Because of battery end of life * Because of upgrade from pacemaker to ICD system * predominant sinus rhythm (paroxysmal atrial fibrillation \[AF\] \< 2 hours/day) * predominant ventricular stimulation (\>= 80%) * NYHA Class II-III * LVEF \<= 35% Exclusion Criteria: * NYHA Class IV * Life expectancy of less than one year because of accompanying diseases * Myocardial infarction less than 3 months old * Cardiac surgery less than 3 months * Bypass * Valve surgery * Percutaneous transluminal coronary angioplasty (PTCA) * Thoracotomy, for implant of an epicardial LV electrode * Medical circumstances that make participation and compliance impossible * Patients who are not willing or able to give written consent for their study participation * Participation in another study * Patients less than 18 years old * Pregnancy

What they're measuring

Cardiopulmonary performance measured by spiroergometry

Timeframe: Baseline to 7 months post-implant

Trial details

NCT IDNCT00157846

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-08