Heart & Vascular Clinical Trials
Merlin Expanded ECG in Left Bundle Branch Area Pacing
What is the purpose of this study?
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.
Eligibility
- 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.
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Subject is currently participating in another clinical investigation that may impact study outcomes, as determined by the study sponsor or lead investigator.
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Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
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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)
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Subject has a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter.
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Subject has evidence of tricuspid stenosis, tricuspid atresia, or any condition that precludes appropriate vascular access for the procedure.
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Subject has an existing lead or device in the right heart or interventricular septum (including lead fragments and closure devices).
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Subject has known allergy or hypersensitivity to <1 mg of dexamethasone sodium phosphate or any blood/tissue-contacting material used in the procedure.
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Subject is unable to receive heparin or an acceptable alternative for anticoagulation.
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Subject has an active systemic infection.
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Subject has known history or repair of atrial septal defect, patent foramen ovale, or ventricular septal defect.
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Subject is unable to read or write
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
Merlin Expanded ECG in Left Bundle Branch Area Pacing
- Disease Type/ConditionHeart Failure, Bradycardia
- Principal InvestigatorRajesh Banker
- Co-InvestigatorsHeba Al-Shoubaki
- Age GroupAdult, Older Adult
- ClinicalTrials.gov IDNCT07877805
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
Jeffrey M. Carlton Heart & Vascular Institute
Hoag’s Jeffrey M. Carlton Heart & Vascular Institute provides advanced, coordinated care for complex heart and vascular conditions, bringing together nationally recognized cardiologists, cardiac surgeons, electrophysiologists, heart failure specialists, and vascular experts. Patients have access to comprehensive evaluation, leading cardiovascular programs, advanced treatment options, and clinical trials designed to help identify the right path forward.
