NCT07877805Not yet recruiting
Merlin Expanded ECG NSR
Merlin Expanded ECG in Left Bundle Branch Area Pacing
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 5 Oct 2026
- Start date
- 5 Oct 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Abbott Medical Devices
- Diseases
- Heart failure
- NCT number
- NCT07877805
What you commit to
- Study type: Observational
- Planned participants: 50
- From 5 Oct 2026 to the primary completion date, 31 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- Subject has evidence of tricuspid stenosis, tricuspid atresia, or any condition that precludes appropriate vascular access for the procedure.
- Subject has an existing lead or device in the right heart or interventricular septum (including lead fragments and closure devices).
- Subject has an active systemic infection.
Lab values
- Subject has known allergy or hypersensitivity to \<1 mg of dexamethasone sodium phosphate or any blood/tissue-contacting material used in the procedure.
Other
- Subject is currently participating in another clinical investigation that may impact study outcomes, as determined by the study sponsor or lead investigator.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter.
- Subject is unable to receive heparin or an acceptable alternative for anticoagulation.
- Subject has known history or repair of atrial septal defect, patent foramen ovale, or ventricular septal defect.
- Subject is unable to read or write
Who the study is looking for
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
- Subject is at least 18 years of age.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.