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Could two pacing leads be better than one for failing hearts?

NCT ID NCT07526896

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 19, 2026 · Updated 4 times

Summary

This study compares two pacing methods in 80 people with heart failure and a specific heart block. One method uses a lead placed in the left bundle branch area; the other adds a second lead in the left ventricle. Each participant will try both methods for six months to see which improves heart function and quality of life more.

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 defibrillator (CRT-D) programmed for left bundle branch area pacing (LBBAP) or combined with left ventricular lead pacing (LOT-CRT)
What this could lead to
If successful, this could show that combining two pacing methods improves heart pumping and quality of life more than one method alone.
What could go wrong
This is a small, early feasibility study with only 80 participants. It may not prove long-term benefit, and results might not apply to all heart failure patients.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

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: * Subject meets current ACC/AHA/HRS guidelines for implantation of a CRT-D device. * Subject has documented LVEF ≤ 35% within 60 days of enrollment. * Subject meets the criteria for presence of Strauss-defined LBBB. * Subject meets NYHA classification II or III. * Subject is willing and able to provide written consent. * Subject is at least 18 years of age at the time of consent. * Subject is geographically stable and willing and able to complete study procedures, including follow-up visits. * The subject's medical records must be accessible by the enrolling site over the follow-up period. Exclusion Criteria: * Subject has documented myocardial infarction before enrollment. * Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD. * Subject has 2nd or 3rd degree AV block. * Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL). * Subject has intrinsic (non-paced) QRS duration ≤ 120ms. * Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads. * Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve). * Subject underwent valve surgery within 90 days prior to enrollment. * Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria. * Subject is post-heart transplantation or is actively listed on the transplantation list. * Subject is implanted with a left ventricular assist device (LVAD). * Subject has severe renal disease. * Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure. * Subject has complex and uncorrected congenital heart disease. * Subject has life expectancy of less than 12 months. * Subject is pregnant or breastfeeding. * Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.

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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.

How to take part

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  1. The official record

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  2. A doctor treating you

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