An observational study in Heart Failure and Bradycardia, sponsored by Abbott Medical Devices. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
This clinical investigation is a prospective, single-arm, multi-center, observational study designed to evaluate the concordance between a simplified electrocardiogram (ECG) method implemented on the Merlin™ 3650 or MER3700 programmer and the standard 12-lead ECG during left bundle branch area pacing (LBBAP) in patients with a bradycardia indication for pacemaker implantation. The study will enroll approximately 50 subjects across up to 5 U.S. sites, with data collected during the implant procedure, and optionally post-implant at the pre-discharge evaluation. No post-discharge follow-up is planned.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 1,719 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.
This intended population for this clinical investigation is adult patients (≥18 years) who are scheduled to undergo pacemaker implantation with left bundle branch area pacing (LBBAP) for the treatment of heart failure or bradycardia. Subjects must meet all eligibility criteria and provide written informed consent prior to any clinical investigation-specific procedures not considered standard of care.
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:
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
Protocol-Specific Screening Exclusion Criteria (if applicable)
Enrollment group will undergo a standard low-voltage lead implant in the left bundle branch area for either bradycardia or heart failure per the site's standard of care. Enrollment group will undergo data collection from different ECG methods.
Device: Left Bundle Branch Implant
Standard of care for left bundle branch implant will be used in the study.
Concordance rate for LBBAP capture assessment between ECG recordings
Concordance rate for LBBAP capture assessment between different ECG recordings
Time frame: Periprocedural
No study locations are listed for this record.
Plan to share: No — Results of the trial will be shared but individua participant data will not be released.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.
Of 160 industry-sponsored observational studies under Heart Failure, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 58. This study's planned 3 months is below that.
Counting every sponsor, half of 825 studies reached it within 40 months; a quarter within 21 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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