Angiography and Electrogram Guided Bachmann Bundle Pacing

NCT07110922 | Recruiting FDA Device

• 1 other identifier: 2025-0403
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Success of Bachmann bundle pacing using angiography at implant

  Perioperative

• Change in implant procedure duration

  Change in implant procedure duration between the two arms

  Perioperative

Secondary Outcomes (3)

• Atrial pacing parameters

  3 month follow up

• Paced P-wave morphology compared to native P-waves

  3 month follow up

• Paced P-wave duration compared to native P-waves

  3 month follow up

Study Arms (2)

Angiography only

EXPERIMENTAL

Diagnostic Test: Angiography only

Angiography and ECG

EXPERIMENTAL

Diagnostic Test: Angiography and ECG

Interventions

Angiography only DIAGNOSTIC_TEST

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

Angiography only

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

Angiography and ECG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age
• Patient with an indication for permanent pacemaker or ICD utilizing atrial pacing lead
• Patient is willing to comply with all study procedures and be available for the duration of the study.

You may not qualify if:

• Inability to provide informed consent
• Pregnant
• Enrolled in a concurrent study that may confound the results of this study.
• Persistent atrial fibrillation at the time of implant (if cardioversion contraindicated at the time of implant, where BB mapping cannot be performed in sinus rhythm)
• Renal dysfunction with serum Creatinine \>3.0 mg/dl

Sponsors & Collaborators

• Pugazhendhi Vijayaraman: lead
• Medtronic: collaborator

Study Sites (1)

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18711, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Interventions

Angiography; Electrocardiography

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis

Study Officials

• Pugazhendhi Vijayaraman, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pugazhendhi Vijayaraman, MD

CONTACT

570-808-6020; pvijayaraman1@geisinger.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cardiac Electrophysiology

Model Details: The study team will randomize 50 patients who satisfy inclusion and exclusion criteria to one of two arms - angiography only guided or angiography and ECG guided BBP lead implant. The study team will compare the difference in procedural success between the two groups.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: August 8, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): September 26, 2027
• Study Completion (Estimated): December 26, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)