Heart FailureNCT07877805
Merlin Expanded ECG NSR
An observational study of Heart Failure and Bradycardia, run by Abbott Medical Devices.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Bradycardia
- What is being tested?
- Left Bundle Branch Implant
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
- 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 a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter.
- 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).
- Subject has known allergy or hypersensitivity to <1 mg of dexamethasone sodium phosphate or any blood/tissue-contacting material used in the procedure.
- Subject is unable to receive heparin or an acceptable alternative for anticoagulation.
- Subject has an active systemic infection.
- Subject has known history or repair of atrial septal defect, patent foramen ovale, or ventricular septal defect.
- Subject is unable to read or write
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Clinical Scientist contact
About this study
Official title: Merlin Expanded ECG in Left Bundle Branch Area Pacing
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.
- Conditions
- Heart Failure, Bradycardia
- Being tested
- Left Bundle Branch Implant
- Keywords
- Left Bundle Branch area pacing, ECG
- Medical subject headings
- Heart Failure, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Bundle Branch ImplantDevice
Standard of care for left bundle branch implant will be used in the study.
| Study group | Role | What they receive |
|---|---|---|
| Enrollment Group | 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. Receives: Device: Left Bundle Branch Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance rate for LBBAP capture assessment between ECG recordings
Concordance rate for LBBAP capture assessment between different ECG recordings
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start5 Oct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877805
- Sponsor's protocol ID
- ABT-CIP-10644
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Results of the trial will be shared but individua participant data will not be released.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Merlin Expanded ECG in Left Bundle Branch Area Pacing
- ClinicalTrials.gov ID
- NCT07877805
- Acronym / sponsor ID
- ABT-CIP-10644
- Conditions
- Heart Failure, Bradycardia
- Keywords
- Left Bundle Branch area pacing, ECG
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrollment Group | – | Device: Left Bundle Branch ImplantEnrollment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- 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 a mechanical tricuspid valve, percutaneous tricuspid valve repair or replacement, or an implanted vena cava filter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Bundle Branch ImplantStandard of care for left bundle branch implant will be used in the study. | Device | Enrollment Group |
Primary outcome
Concordance rate for LBBAP capture assessment between ECG recordings
Time frame: Periprocedural
Concordance rate for LBBAP capture assessment between different ECG recordings
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. Results of the trial will be shared but individua participant data will not be released.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Scientist contact
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Bradycardia, run by Abbott Medical Devices.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (+1 818-282-2302, pooja.maddula@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance rate for LBBAP capture assessment between ECG recordings (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.