334 Participants NeededMy employer runs this trial

Bachmann's Bundle vs Right Atrial Appendage Pacing for Atrial Fibrillation

(BACH-RAP Trial)

CP
HM
Overseen ByHeather McDonald, MHA CCRC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 (BB) in the right atrium (upper right chamber of the heart) Arm B: Pacing from the right atrial appendage (RAA - 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.

Who Is on the Research Team?

JS

Joshua Silverstein, MD

Principal Investigator

Allegheny Health Network

Are You a Good Fit for This Trial?

This trial is for people with atrial fibrillation who need a pacemaker in the right atrium. Participants should be able to attend follow-up visits and provide blood samples. Specific inclusion or exclusion criteria are not detailed here.

Inclusion Criteria

I am getting a new heart device with an atrial lead implanted.
I am 18 years old or older.
Medtronic CIED system used
See 2 more

Exclusion Criteria

Prior CIED implant
I have been diagnosed with pericarditis or fluid around my heart.
My heart condition severely limits my physical activity, even at rest.
See 5 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two standard ways of placing pacemaker leads: one at Bachmann's Bundle and the other at the right atrial appendage. Participants are randomly assigned to either group, and both procedures are commonly used by heart specialists.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Bachmann's Bundle PacingActive Control1 Intervention
Group II: Right Atrial Appendage PacingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead Sponsor

Trials
52
Recruited
13,000+

Medtronic

Industry Sponsor

Trials
627
Recruited
767,000+
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Geoff Martha

Medtronic

Chief Executive Officer since 2020

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Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

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