Merlin Expanded ECG NSR

NCT07877805 — Not yet recruiting, 50 participants, Abbott Medical Devices

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Merlin Expanded ECG in Left Bundle Branch Area Pacing

Registry	NCT07877805
Status	Not yet recruiting
Study type	Observational
Enrollment	50 (Estimated)
Sponsor	Abbott Medical Devices (Industry)
Conditions	Heart Failure, Bradycardia
Interventions	Left Bundle Branch Implant (Device)
Dates	start 2026-10-05 (estimated), primary completion 2027-01-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-10-16, last updated 2026-10-16

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Enrollment Group		Device: Left Bundle Branch Implant	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.

Left Bundle Branch Implant (Device): Standard of care for left bundle branch implant will be used in the study.

+Outcome measures

Primary outcomes

Concordance rate for LBBAP capture assessment between ECG recordings [Periprocedural]: Concordance rate for LBBAP capture assessment between different ECG recordings

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Subject must provide written informed consent prior to any clinical investigation-related procedure.
2. Subject is at least 18 years of age.
3. Subject is scheduled to 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.

Exclusion Criteria:

1. Subject is currently participating in another clinical investigation that may impact study outcomes, as determined by the study sponsor or lead investigator.
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
3. 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)
4. Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter.
5. Subject has evidence of tricuspid stenosis, tricuspid atresia, or any condition that precludes appropriate vascular access for the procedure.
6. Subject has an existing lead or device in the right heart or interventricular septum (including lead fragments and closure devices).
7. Subject has known allergy or hypersensitivity to <1 mg of dexamethasone sodium phosphate or any blood/tissue-contacting material used in the procedure.
8. Subject is unable to receive heparin or an acceptable alternative for anticoagulation.
9. Subject has an active systemic infection.
10. Subject has known history or repair of atrial septal defect, patent foramen ovale, or ventricular septal defect.
11. Subject is unable to read or write