Could two pacing leads be better than one for failing hearts?
NCT ID NCT07526896
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 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: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Heart failure are added.
Genom att skicka in godkänner du våra Användarvillkor
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
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an inhaler boost heart pumping in COPD patients?
- Can zapping the heart beat drugs for AF in heart failure?
- Which SGLT2 inhibitor wins? trial pits empagliflozin against dapagliflozin
- Can daily mindful breathing ease heart failure symptoms?
- Can a smartphone app keep heart failure patients out of the hospital?
- Can better training get doctors to talk about what matters most to dying veterans?