BACHmann Bundle Versus Right Atrial Appendage Pacing Randomized Controlled Trial: Learning Curve, Safety, Efficacy, Physiological Effect, and Transthoracic Echo Guidance
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Summary
Participants will be randomly assigned to one of two clinical treatment Arms, both of which are standard care procedures performed in the right atrium (RA): Arm A: Pacing from the Bachmann's Bundle in the right atrium (upper right chamber of the heart) Arm B: Pacing from the right atrial appendage (a sac attached to the right atrium) Neither of these treatments are experimental; both are routinely performed by Electrophysiologists in the clinical setting. The purpose of this study is to compare side by side these two treatments and evaluate if one is better than the other. After the procedure, participants will be followed for one year. Medical record data will be collected, and a blood sample will be collected upon enrollment and at one year after implantation. Research-related surveys will be completed at the standard-care 3-, 6-, and 12-month visits.
Description
Patients requiring CRT will screened for the study prior to any research procedures. Once consent has been granted, participants will be randomly assigned to Arm A (BB pacing) or Arm B (RAA pacing). After the procedure, they will have post-implantation visits at 3, 6, and 12 months. The purpose of the study is to compare the safety of Bachmann bundle versus right atrial appendage lead placement to reduce the incidence of the composite outcome of cardiac perforation, pericarditis, lead dislodgement, pericardial effusion, lead revision, and all-cause mortality within 12-month of follow-up
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients undergoing a de novo CIED (i.e. pacemaker, ICD, CRT) implant with an atrial lead * Medtronic CIED system used * Age 18 years or older * Able to read and understand English AND EITHER 1)willing and capable of providing informed consent OR 2) in case of incompetence, be represented by a legally authorized representative (LAR), relative/associate with power of attorney (POA), or other recognized surrogate decision-maker who can read and understand English and is willing and capable of providing consent. * Able and willing to participate in all examinations and foll…
Interventions
- DeviceBachmann's Bundle
BBP
- DeviceRight Atrial Appendage Pacing
RAA pacing
Location
- Allegheny General HospitalPittsburgh, Pennsylvania