Recruiting soon

ABPCardiac Anodal Biphasic Pacing in Patients with Non-Ischemic Cardiomyopathy

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What is being tested

Cardiac Waveform Generator

Device
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorBoston Medical Center
Study ContactRobert Helm, MDMore contacts
Last updated: December 30, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2026

Actual date on which the first participant was enrolled.

This clinical study focuses on a special type of heart pacing called Anodal Biphasic Pacing (ABP). It is designed to help people with normal heart structures as well as those who have a heart condition known as non-ischemic cardiomyopathy. The participants are individuals who are either getting a new heart device implanted or having an existing one replaced. The goal is to see if ABP can provide better blood flow benefits compared to the traditional method called cathodal pacing. Researchers aim to determine which patients benefit the most from ABP and to ensure it does not have negative effects, especially on those who do not respond to traditional pacing methods. This study could lead to better heart care by optimizing how electronic devices support the heart's function. Participants in this study will undergo procedures at Boston Medical Center, where they will receive or replace a cardiac implantable electronic device (CIED). They will be grouped based on their heart's ability to pump blood, known as the ejection fraction. The study will measure how well ABP improves heart function compared to cathodal pacing, focusing on finding the best settings for ABP. Additionally, safety is a key concern, so the study will look for any unusual heart rhythms and ensure the devices and procedures are safe. The research does not mention specific risks or benefits, but the primary focus is on improving the effectiveness and safety of heart devices for patients.

Official TitleCardiac Anodal Biphasic Pacing 
Principal SponsorBoston Medical Center
Study ContactRobert Helm, MDMore contacts
Last updated: December 30, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

108 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: Cohort A • Planned interventional cardiac procedure Cohort B * Planned generator exchange of dual chamber cardiac implantable electronic device (CIED) * Functioning atrial lead Cohort C * Planned de novo implant or generator exchange of CIED with cardiac resynchronization therapy * Functioning atrial lead Exclusion Criteria: * Permanent atrial fibrillation * Third degree AV block without stable escape rhythm * Ischemic heart disease or coronary disease \> 40% * Unable to receive heparin * Are not fluent in English * Unable to read in English * Not able to provide informed consent * Women who are pregnant

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Cardiac patients who are undergoing interventional cardiac procedure including electrophysiology (EP) with planned retrograde left ventricular access or diagnostic coronary catheterization.

Group II

Experimental
Patients who have pacing indication and are undergoing routine generator exchange of dual chamber cardiac implantable electronic device (CIED).

Group III

Experimental
Patients who are undergoing new implant or generator exchange of CIED with cardiac resynchronization therapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Boston Medical Center

Boston, United StatesSee the location
Recruiting soonOne Study Center