CompletedNot Applicable

TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study

Germany40 participantsStarted 2007-11

Plain-language summary

It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and CRT timing on the outcome of cardiac resynchronization therapy (CRT).

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: * Patient with indication for CRT-D: NYHA III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure * LVEDD \> 55 mm or \> 30 mm/m² BSA * EF \< 35% * Sinus rhythm and one of the following criteria: * QRS \>= 120 ms and PQ \>= 200ms * or * 2nd / 3rd degree AV block * Written informed consent Exclusion Criteria: * pacemaker indication (without ICD indication) * tricuspidal valve and/or aortic valve replacement * Indication for revascularization. * less than 3 month after heart surgery or myocardial infarction * hypertrophic obstructive cardiomyopathy * intravenous catecholamine treatment * uncorrected thyroid function * severe kidney disorder (creatinin \>2,5mg%) * no written patient consent * insufficient patient compliance * participating in another study * life expectancy \< 1 year due to other severe disease * age \< 18 years * no contraception (young women) or 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

Improvement according to Packer's "Heart Failure Clinical Composite Respond"

Timeframe: 12 months post implant

Trial details

NCT IDNCT00746135

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10

View on ClinicalTrials.gov More Heart Failure trials

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.