Cardiac Anodal Biphasic Pacing (ABP)

Boston Medical Center (BMC)

Status: Begins enrollment this month

Conditions: Cardiac Pacing

Treatments: Device: Cardiac Waveform Generator

Study type: Interventional

Funder types: Other

Identifiers

NCT07173777

H-46078

Details and patient eligibility

About

The goal of this study is to test a new pacing method called anodal biphasic pacing (ABP) to determine if this pacing works as well-or better-than current pacing methods. This new method may improve how the heart works and reduce some of the problems caused by regular pacing.

Current implantable pacemakers use a monophasic cathodal waveform to stimulate the heart. Monophasic cathodal pacing (MCP) waveforms slow conduction, impair contractility, cause inflammation, increase risk of atrial fibrillation, heart failure, and mortality. Anodal biphasic pacing (ABP) is an alternative waveform that can stimulate the heart. ABP preconditions the heart and then initiates cardiac contraction. ABP may address the limitations of MCP.

Full description

This study is a single-center, prospective, investigator-initiated, non-randomized, study that will investigate ABP in patients with structurally normal hearts and those with non-ischemic cardiomyopathy who are undergoing interventional cardiac procedure, generator exchange of dual chamber Cardiac implantable electronic device (CIED), or de novo implant or generator exchange of CIED with cardiac resynchronization therapy.

Eligible participants, without heart disease and those with nonischemic cardiomyopathy, undergoing CIED implant or generator exchange or interventional cardiac procedure at Boston Medical Center will be screened and prospectively enrolled. Participants will be stratified by left ventricular ejection fraction (EF): those with severely reduced EF (≤35%), mid-range EF (> 35%-49%) and normal EF (EF≥ 50%).

Primary efficacy objectives:

1. To identify which patient populations have the greatest and most consistent hemodynamic benefit from ABP as compared with cathodal pacing.
2. To confirm that ABP does not negatively impact non-responders.
3. To define the ideal anodal biphasic waveform characteristics (amplitude and pulse width) that maximizes the positive effect in subjects who demonstrate hemodynamic improvement ABP
4. To assess differences in capture thresholds between anodal biphasic and cathodal pacing.

Secondary safety objectives:

1. To assess and characterize any ventricular arrhythmias associated with anodal biphasic in comparison to cathodal pacing.
2. To assess device safety
3. To assess procedure safety

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Cohort A

Experimental group

Description:

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

Treatment:

Device: Cardiac Waveform Generator

Cohort B

Experimental group

Description:

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

Treatment:

Device: Cardiac Waveform Generator

Cohort C

Experimental group

Description:

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

Treatment:

Device: Cardiac Waveform Generator