Cardiac Anodal Biphasic Pacing

NCT07173777 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: H-46078
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Pacing

Keywords

Anodal biphasic pacing (ABP); Monophasic cathodal pacing (MCP); Ejection fraction; Cardiac implantable electronic device; Cardiac contractility modulation; Implantable cardiac defibrillator

Outcome Measures

Primary Outcomes (6)

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

  about 30 minutes

• Clinically significant 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 stroke work.

  about 30 minutes

• Clinically significant left ventricular end-diastolic pressure (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 LVEDP.

  about 30 minutes

• Clinically significant diastolic relaxation (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 tau.

  about 30 minutes

• Clinically significant volume measurements

  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.

  about 30 minutes

• Capture threshold

  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.

  about 30 minutes

Secondary Outcomes (3)

• Waveform safety concerns

  about 30 minutes

• Device safety issues

  about 30 minutes

• Procedural safety issues

  about 30 minutes

Study Arms (3)

Cohort A

EXPERIMENTAL

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

Device: Cardiac Waveform Generator

Cohort B

EXPERIMENTAL

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

Device: Cardiac Waveform Generator

Cohort C

EXPERIMENTAL

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

Device: Cardiac Waveform Generator

Interventions

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.

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• Rocky Mountain Biphasic: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Study Officials

• Robert Helm, MD

  Boston Medical Center, Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Helm, MD

CONTACT

617-638-8985; robert.helm@bmc.org

Denise Fine, BS

CONTACT

617-638-8716; denise.fine@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)