Status:
NOT_YET_RECRUITING
Cardiac Anodal Biphasic Pacing
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
Rocky Mountain Biphasic
Conditions:
Cardiac Pacing
Eligibility:
All Genders
18+ years
Phase:
NA
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 h...
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 cardiomyopat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT07173777
Start Date
February 1 2026
End Date
July 1 2027
Last Update
December 29 2025
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118