Cardiac Anodal Biphasic Pacing
ConditionCardiac Pacing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Planned generator exchange of dual chamber cardiac implantable electronic device (CIED)
Functioning atrial lead
Planned de novo implant or generator exchange of CIED with cardiac resynchronization therapy
Functioning atrial lead
Disqualifiers
Permanent atrial fibrillation
Third degree AV block without stable escape rhythm
Ischemic heart disease or coronary disease > 40%
Unable to receive heparin
Trial design
Treatments tested in this trial
- Cardiac Waveform Generator
Treatment groups
108 Participants
are divided into 3 treatment groupsSponsors and collaborators
Boston Medical Center
Lead sponsor
Rocky Mountain Biphasic
Collaborator
Source ClinicalTrials.gov