Can we predict who benefits from a heart device? new study aims to find out
NCT ID NCT06977217
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is for heart failure patients who do not have a specific heart rhythm pattern called left bundle branch block (non-LBBB). These patients often get a device called CRT-D, which combines a pacemaker and a defibrillator, but not everyone responds well. Researchers will follow 270 patients for 12 months to see if certain tests before implantation can predict who will improve. The goal is to develop a scoring system to help doctors choose the right patients for this therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cardiac resynchronization therapy with a defibrillator (CRT-D)
- What this could lead to
- If successful, this could help doctors identify which heart failure patients without a specific ECG pattern will benefit most from CRT-D, improving outcomes and avoiding unnecessary procedures.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly test a new therapy. The findings may not apply to all patients, and the predictive score needs further validation before clinical use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
270 people
The number who actually took part.
- Started
-
Mar 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Study population will include 270 HF patients with non-LBBB and an implanted CRT-D device.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older (no upper limit) * Optimal medical therapy for heart failure as established by current guidelines; * Class IIa or IIb guideline-based indication for CRT-D in non-LBBB patients, including one of the following: * New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); * NYHA class III-IVa HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); * NYHA class III-IVa HF, LVEF ≤ 35%, and QRS duration 120- 149 ms (IIb) * Successful CRT-D generator implant Exclusion Criteria: * Unable to obtain imaging data from echocardiogram within 1 year prior to CRT-D implant * Unable to obtain the 20-minute ECG prior to CRT-D implant * Unable to enroll within 14 days following successful CRT-D generator implant * Unable or unwilling to follow the study protocol * Less than 24 months life expectancy at enrollment * Pregnancy or planned pregnancy in the next 24 months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Rochester Medical Center
Rochester, New York, 14642, United States
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