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NCT Number: NCT07173777

Cardiac Anodal Biphasic Pacing

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.

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Key information

Conditions

Cardiac Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

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

Secondary safety objectives:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Waveform Generator

Device

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.

Primary outcomes

  1. Clinically significant maximum rate of pressure change maximum rate of pressure change within the left ventricle during its contraction phase- dP/dtmax.

    Time frame: about 30 minutes

    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.

  2. Clinically significant stroke work

    Time frame: about 30 minutes

    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.

  3. Clinically significant left ventricular end-diastolic pressure (LVEDP)

    Time frame: about 30 minutes

    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.

  4. Clinically significant diastolic relaxation (tau)

    Time frame: about 30 minutes

    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.

  5. Clinically significant volume measurements

    Time frame: about 30 minutes

    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.

  6. Capture threshold

    Time frame: about 30 minutes

    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 outcomes

  1. Waveform safety concerns

    Time frame: about 30 minutes

    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.

  2. Device safety issues

    Time frame: about 30 minutes

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

  3. Procedural safety issues

    Time frame: about 30 minutes

    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 contacts

Contact information is provided by the study sponsor or research team.

Denise Fine, BS

CONTACT

[email protected]

617-638-8716

Robert Helm, MD

CONTACT

[email protected]

617-638-8985

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Rocky Mountain Biphasic

Registry information

Acronym: ABP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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