Recruiting

Contrast Dye & ECG

Sponsor:

Pugazhendhi Vijayaraman

Code:

NCT07110922

Conditions

Heart Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Angiography only

Angiography and ECG

Study Details

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

Study ID

NCT07110922

Start date

Aug 15, 2025

Status verified date

Sep, 2025

Completion date

Dec 26, 2027

Anticipated

Primary completion date

Sep 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Inability to provide informed consent
2. Pregnant
3. Enrolled in a concurrent study that may confound the results of this study.
4. 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)
5. Renal dysfunction with serum Creatinine >3.0 mg/dl

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Angiography only

experimental: Angiography and ECG

Interventions

Angiography only

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

Angiography and ECG

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

Primary outcome measure

  • Success of Bachmann bundle pacing using angiography at implant [ Time Frame: Perioperative ]
  • Change in implant procedure duration [ Time Frame: Perioperative ]

Central Contacts and Locations

Central contacts

Pugazhendhi Vijayaraman, MD

570-808-6020pvijayaraman1@geisinger.edu

Locations

Geisinger Wyoming Valley

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Vijayaraman Pugazhendi, MD

5708086020pvijayaraman1@geisinger.edu

More Information

Sponsor

Pugazhendhi Vijayaraman

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pugazhendhi Vijayaraman on 2025-09-22.