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Not yet recruiting NCT07173777

Cardiac Anodal Biphasic Pacing

No phase Interventional Cardiac Pacing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardiac Waveform Generator.
Who it may be relevant to
Registry conditions: Cardiac Pacing. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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:

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

Interventions

  • Device 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.

Primary outcome measures

  • 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]
  • Clinically significant stroke work [Time frame: about 30 minutes]
  • Clinically significant left ventricular end-diastolic pressure (LVEDP) [Time frame: about 30 minutes]
  • Clinically significant diastolic relaxation (tau) [Time frame: about 30 minutes]
  • Clinically significant volume measurements [Time frame: about 30 minutes]
  • Capture threshold [Time frame: about 30 minutes]
Secondary outcome measures (3)
  • Waveform safety concerns [Time frame: about 30 minutes]
  • Device safety issues [Time frame: about 30 minutes]
  • Procedural safety issues [Time frame: about 30 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Boston Medical Center — Boston

Identifiers

NCT: NCT07173777 · H-46078

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗