Cardiac PacingABPNCT07173777
Cardiac Anodal Biphasic Pacing
A study testing Cardiac Waveform Generator in people with Cardiac Pacing, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacing
- What is being tested?
- Cardiac Waveform Generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Medical Center
Boston, Massachusetts, 02118
Robert Helm, MD, robert.helm@bmc.org
Denise Fine, BS, denise.fine@bmc.org
About this study
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.
Read the detailed 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:
- 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
- Conditions
- Cardiac Pacing
- Being tested
- Cardiac Waveform Generator
- Keywords
- Anodal biphasic pacing (ABP), Monophasic cathodal pacing (MCP), Ejection fraction, Cardiac implantable electronic device, Cardiac contractility modulation, Implantable cardiac defibrillator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Waveform GeneratorDevice
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 group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Cardiac patients who are undergoing interventional cardiac procedure including electrophysiology (EP) with planned retrograde left ventricular access or diagnostic coronary catheterization. Receives: 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). Receives: Device: Cardiac Waveform Generator |
| Cohort C | Experimental | Patients who are undergoing new implant or generator exchange of CIED with cardiac resynchronization therapy. Receives: Device: Cardiac Waveform Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: about 30 minutes
Secondary outcomes (3)
Waveform safety concerns
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.
Measured: about 30 minutes
Device safety issues
Defined as the occurrence of device related adverse event including: device malfunction, failure to output programmed pulse waveform, or failure to output set voltage
Measured: about 30 minutes
Procedural safety issues
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.
Measured: about 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac PacingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rocky Mountain Biphasic
- Responsible party
- Sponsor
- Investigators
- Robert Helm, MD, Principal investigator, Boston Medical Center, Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173777
- Sponsor's protocol ID
- H-46078
- Acronym
- ABP
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Anodal Biphasic Pacing
- ClinicalTrials.gov ID
- NCT07173777
- Acronym / sponsor ID
- ABP / H-46078
- Conditions
- Cardiac Pacing
- Keywords
- Anodal biphasic pacing (ABP), Monophasic cathodal pacing (MCP), Ejection fraction, Cardiac implantable electronic device, Cardiac contractility modulation, Implantable cardiac defibrillator
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Rocky Mountain Biphasic
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Device: Cardiac Waveform GeneratorCardiac patients who are undergoing interventional cardiac procedure including electrophysiology (EP) with planned retrograde left ventricular access or diagnostic coronary catheterization. |
| Cohort B | Experimental | Device: Cardiac Waveform GeneratorPatients who have pacing indication and are undergoing routine generator exchange of dual chamber cardiac implantable electronic device (CIED). |
| Cohort C | Experimental | Device: Cardiac Waveform GeneratorPatients who are undergoing new implant or generator exchange of CIED with cardiac resynchronization therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cohort A
- Planned interventional cardiac procedure
- Cohort B
- Planned generator exchange of dual chamber cardiac implantable electronic device (CIED)
- Functioning atrial lead
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Waveform GeneratorA 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. | Device | Cohort A, Cohort B, Cohort C |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Waveform safety concerns
Time frame: about 30 minutes
Device safety issues
Time frame: about 30 minutes
Procedural safety issues
Time frame: about 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Helm, MD principal investigator
Boston Medical Center, Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Waveform Generator in people with Cardiac Pacing, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Helm, MD (617-638-8985, robert.helm@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.