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ABP

Cardiac 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, 2026Actual 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 
NCT07173777
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf 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.

A pacing device that allows for programmable pulse waveforms to generate a predefined set of anodal biphasic waveforms. It possesses a battery-powered floating point gate array (FPGA) using software that allows flexibility in waveform configuration.
Group II
Experimental
Patients who have pacing indication and are undergoing routine generator exchange of dual chamber cardiac implantable electronic device (CIED).

A pacing device that allows for programmable pulse waveforms to generate a predefined set of anodal biphasic waveforms. It possesses a battery-powered floating point gate array (FPGA) using software that allows flexibility in waveform configuration.
Group III
Experimental
Patients who are undergoing new implant or generator exchange of CIED with cardiac resynchronization therapy.

A pacing device that allows for programmable pulse waveforms to generate a predefined set of anodal biphasic waveforms. It possesses a battery-powered floating point gate array (FPGA) using software that allows flexibility in waveform configuration.
Study Objectives
Primary Objectives

Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in dP/dtmax.

Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in stroke work.

Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in LVEDP.

Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in tau.

Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in volume measurements.

This outcome will be measured with decremental pacing threshold testing where pacing output (voltage or pulse width) is decremented until there is a loss of ventricular capture. The minimum output prior to loss of capture is defined as the capture threshold.
Secondary Objectives

Defined as the development of any of the following with ABP: ventricular tachycardia \> 3 beats, premature ventricular contractions at frequency greater than baseline, ventricular couplet, significant drop (\>5%) in invasive hemodynamic measures or blood pressure; or any cardioversion for atrial or ventricular arrhythmia.

Defined as the occurrence of device related adverse event including: device malfunction, failure to output programmed pulse waveform, or failure to output set voltage

Defined as the occurrence of procedure related adverse event including: vascular complication, cardiac complication including cardiac perforation, valvular injury, atrioventricular (AV) or bundle branch block, or thromboembolism.

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 CenterBoston, United StatesSee the location
Recruiting soonOne Study Center