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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Heart Failure, Congestive trials