CompletedPhase 2/3

Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.

Canada96 participantsStarted 2011-03

Plain-language summary

Identifying \& optimizing strategies to reduce the burden of heart failure is vital. Despite advances in pharmacotherapy, patients with heart failure are at high risk for death \& hospitalization. Cardiac resynchronization therapy (CRT) synchronizes ventricular mechanical activity, improves cardiac output \& reduces HF symptoms. However, \~50% of patients do not clearly respond to CRT. Sub-optimal placement of the LV pacing lead appears to be an important reason for non-response. This study will assess whether targeted LV lead placement will result in an increased probability of CRT response at 52 weeks vs. usual (lateral wall) lead placement.

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: * LV EF ≤ 0.40 measured within 3 months of enrollment, * SAS class 3 or 4 symptoms indicative of moderate to severe functional capacity limitation due to heart failure within 1 month of enrollment. * Confirmed dyssynchrony on screening echo (1.1.9), \& * On stable doses of ACE inhibitor or angiotensin II blocker \& a beta-blocker for ≥ 2 months unless medically contra-indicated. * Controlled heart rate if in permanent AF (resting \<70 \& maximal \<120). Exclusion Criteria: * Unable or unwilling to provide informed consent, * Medical condition other than heart failure likely to cause death \< 1 year, * Cardiac transplant planned within 6 months, * Known contra-indication to transvenous CRT device implant (e.g., active sepsis, artificial tricuspid valve, known vascular occlusion that will prevent delivery of leads transvenously), * Clinically significant myocardial infarction within last 2 months, or * Coronary bypass graft surgery ≤ 2 months or coronary angioplasty ≤ 1 month

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

Change in end systolic volume plus reduction in symptoms

Timeframe: over 12 months

Trial details

NCT IDNCT00399594

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

View on ClinicalTrials.gov More Heart Failure, Congestive trials