ABPCardiac Anodal Biphasic Pacing in Patients with Non-Ischemic Cardiomyopathy
Cardiac Waveform Generator
Diagnostic Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.108 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy 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