An interventional study of Optimization of CRT Device in Heart Failure, Systolic, sponsored by Alan J. Bank, MD. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2021-09-27.
Sponsored by Alan J. Bank, MD · Not applicable, Interventional, and Treatment
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Among 83 studies in Heart Failure, Systolic with a site in United States — 17 open to participants now, 21 under way, none of them phase 3. Heart Failure, Systolic · United States.
Among the 83 studies in Heart Failure, Systolic with a site in United States, this one is the 60th largest by enrollment of the 69 interventional ones that give a count, is one of 4 that started in 2017, is one of 44 with no phase, and was the 28th registered.
230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.
Browse Heart Failure, Systolic studies →17 of the 83 studies in Heart Failure, Systolic with a site in United States are open now. Recruiting first, the newest first:
Abiomed Inc. · Sites in United States
Ages 18–80
Eli Lilly and Company · Sites in United States, Japan, Moldova and 2 more countries
Ages 18–65
Kaiser Permanente · Sites in United States
Ages 18+
Impulse Dynamics · Sites in United States
Ages 18+
Yale University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Heart Failure, Systolic studies recruiting now, 19 (66%) set no upper age limit and 2 (7%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 110 Years · all sexes · no healthy volunteers.
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83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 10 · Phase 3 2 · Phase 4 8
First in 2005; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3 is below the median of 60 across 165 interventional studies indexed under Heart Failure, Systolic.
Median enrollment 40 across the 69 interventional studies, 148 across the 14 observational. Of the 48 that completed or were terminated, 17 (35%) have results posted.
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24 of 83 have an industry lead sponsor. The 10 most frequent:
Alan J. Bank, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Alan J. Bank, MD has 1 study filed under Heart Failure, Systolic — fewer than ten, so there is no comparison to draw.
7 of the studies in Heart Failure, Systolic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925608BioCardia, Inc.Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells | 2026-12 |
| NCT06009276University of VirginiaAssociations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status | 2026-12 |
| NCT06671015Yale UniversityA Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure | 2027-01 |
| NCT07252310Weill Medical College of Cornell UniversityPilot Study of StudyU for N-of-1 Trials in HFrEF Patients (N-of-1 App) | 2027-02 |
| NCT05230732University of OklahomaNeuromodulation of Inflammation and Endothelial Function | 2027-02-27 |
Add all 7 to your calendar (.ics) → With an account.
Among the 83 studies in Heart Failure, Systolic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.
This is a prospective randomized study designed to determine whether cardiac resynchronization therapy (CRT) device programming guided by the ECG Belt (Medtronic, PLC) improves echocardiographic and functional outcomes in heart failure (HF) patients. The population will include patients treated with CRT for standard indications (not implanted for the sole purposes of this study). The study will focus enrollment on patients who do not have baseline characteristics predicting the best CRT response. Therefore the study will not enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and QRSd > 150 ms or those previously RV paced.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use ECG Belt body surface mapping system to optimize CRT programming.
Diagnostic Test: Optimization of CRT Device
Use mitral inflow echocardiography to optimize CRT programming.
Diagnostic Test: Optimization of CRT Device
Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.
Echocardiographic assessment of LV function
Change in ejection fraction
Time frame: 6 months post optimization
Echocardiographic assessment of LV size
Change in left ventricular end-systolic volume
Time frame: 6 months post optimization
Plan to share: No — We do not plan to share IPD with other researchers.
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Aug 2021, 45 months.
Of 52 non-industry interventional studies with no phase under Heart Failure, Systolic, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's 45 months is above that.
Counting every sponsor, half of 56 studies reached it within 30 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Alan J. Bank, MD