Effects of CRT Optimization as Assessed by Cardiac MR (NCT04763460) | Clinical Trial Compass
WithdrawnNot Applicable
Effects of CRT Optimization as Assessed by Cardiac MR
Stopped: No local enrollment due to capacity
United States0Started 2023-06-01
Plain-language summary
Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize CRT device programming in patients considered non-responders to CRTusing information obtained from standard ECG machines, and to assess acute and chronic effects of CRT optimization using cardiac magnetic resonance imaging (CMR).
Who can participate
Age range
18 Years – 100 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
. Currently on standard medical therapy
. CRT device in place for \> 4 months
. Non-responder (ejection fraction improvement with CRT \< 5%) or incomplete responder (ejection fraction \< 40%)
. Suboptimal electrical wavefront fusion at current CRT programming as observed on 12-lead ECG
. Left bundle branch block, interventricular conduction delay or right ventricular paced underlying QRS complex
. Age \> 18 years
Exclusion criteria
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
1
Acute changes in left ventricular mechanical synchrony in study population
Timeframe: During Baseline Assessment
2
Acute changes in left ventricular regional wall motion in study population
Timeframe: During Baseline Assessment
3
Acute changes in left ventricular end-diastolic volume in study population
Timeframe: During Baseline Assessment
4
Acute changes in left ventricular end-systolic volume in study population
Timeframe: During Baseline Assessment
5
Chronic changes in left ventricular mechanical synchrony
Timeframe: Baseline to 12 months
6
Chronic changes in left ventricular regional wall motion
Timeframe: Baseline to 12 months
7
Chronic changes in left ventricular end-diastolic volume
. History of severe allergic reactions to ECG gels, electrode adhesives, and/or cardiac magnetic resonance contrast (e.g. gadolinium)
. Implantation of pacing lead in the his bundle or left bundle branch
. Frequent ventricular ectopy as defined as \>10% premature ventricular contraction burden by either device interrogation or Holter monitor, or sustained ventricular tachycardia/ventricular fibrillation
. Patient is enrolled in concurrent research study that would potentially confound the results of this study (noting: co-enrollment acceptable if patient is enrolled in registry study)
8
Chronic changes in left ventricular end-systolic volume