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Can we predict who benefits from a heart device? new study aims to find out

NCT ID NCT06977217

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

18 years and older

Sex

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.