Angiography and Electrogram Guided Bachmann Bundle Pacing

Part of paid clinical trials in Wilkes-Barre, Pennsylvania.

Sponsor
Pugazhendhi Vijayaraman
Study ID
NCT07110922
Status
Recruiting
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Conditions

  • Heart Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Angiography only — DIAGNOSTIC_TEST
    Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region
  • Angiography and ECG — DIAGNOSTIC_TEST
    Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region and correlate with electrogram guidance for BBP

Study Details

People eligible for this study are scheduled to have a permanent pacemaker (PPM) or defibrillator device (ICD) implanted as part of their routine care. This device will also have a wire placed in the right atrium (RA) of the heart. As an alternative to the RA, the wire can also be placed in the Bachmann bundle (BB). This study is being done to compare two options to help place the wire in the Bachmann bundle. One option uses contrast dye and x-ray, and the other option uses electrocardiogram (ECG) and contrast dye and x-ray. We want to learn more about how well these options work in implanting the wire in the Bachmann bundle. Both of these options are FDA approved and used in standard practice.

Key Dates

Start date
Aug 15, 2025
Status verified
Sep 2025
Primary completion
Sep 26, 2027
Completion
Dec 26, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Angiography only
  • Experimental: Angiography and ECG

Primary Outcome Measure

Success of Bachmann bundle pacing using angiography at implant [ Time Frame: Perioperative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Geisinger Wyoming ValleyWilkes-BarrePennsylvania18711
Vijayaraman Pugazhendi, MD
[email protected]
5708086020

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Geisinger Wyoming Valley· Wilkes-Barre, PA

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