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Angiography and Electrogram Guided Bachmann Bundle Pacing

NCT07110922 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Heart Diseases

Interventions

DIAGNOSTIC_TEST

Angiography only

Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region

DIAGNOSTIC_TEST

Angiography and ECG

Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region and correlate with electrogram guidance for BBP

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Pugazhendhi Vijayaraman

    lead OTHER

Principal Investigators

  • Pugazhendhi Vijayaraman, MD · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2027-09-26
Completion
2027-12-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07110922 on ClinicalTrials.gov