Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
108 participants
INTERVENTIONAL
2026-02-28
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A
Cardiac patients who are undergoing interventional cardiac procedure including electrophysiology (EP) with planned retrograde left ventricular access or diagnostic coronary catheterization.
Cardiac Waveform Generator
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 B
Patients who have pacing indication and are undergoing routine generator exchange of dual chamber cardiac implantable electronic device (CIED).
Cardiac Waveform Generator
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 C
Patients who are undergoing new implant or generator exchange of CIED with cardiac resynchronization therapy.
Cardiac Waveform Generator
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cardiac Waveform Generator
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
• 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rocky Mountain Biphasic
UNKNOWN
Boston Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Helm, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center, Cardiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Boston Medical Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Robert Helm, MD
Role: primary
Denise Fine, BS
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-46078
Identifier Type: -
Identifier Source: org_study_id