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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cardiac Waveform Generator
DeviceA 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.
Treatment groups
108 Participants
are divided into 3 treatment groupsGroup A: Cohort AExperimental treatment 1 intervention
Group B: Cohort BExperimental treatment 1 intervention
Group C: Cohort CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
about 30 minutes2
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.
Time frame
about 30 minutes3
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.
Time frame
about 30 minutes4
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.
Time frame
about 30 minutesSecondary outcomes
1
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.
Time frame
about 30 minutes2
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
Time frame
about 30 minutes3
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.
Time frame
about 30 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Medical Center
Lead sponsor
Rocky Mountain Biphasic
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: