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Search / Trial NCT07110922

Angiography and Electrogram Guided Bachmann Bundle Pacing

Launched by PUGAZHENDHI VIJAYARAMAN · Aug 1, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two ways to place a special wire inside the heart during the implant of a permanent pacemaker or defibrillator, which are devices that help control abnormal heart rhythms. The wire is usually placed in the right upper chamber of the heart (called the right atrium), but this study is looking at placing it in a specific area called the Bachmann bundle, which may improve how the heart’s upper chambers work together. The researchers want to compare two methods for guiding the wire into this spot: one uses a type of X-ray with contrast dye, and the other uses both this X-ray method and heart rhythm monitoring (an electrocardiogram or ECG).

People who are 18 years or older and are already scheduled to get a pacemaker or defibrillator with a wire in the upper heart chamber may be eligible to join. Participants need to be able to follow the study’s procedures and be available for follow-up. The study is not yet recruiting. If you join, you will have one of the two approved methods used to guide the wire placement during your device implant, which is a standard part of care. Certain people, such as those who cannot give consent, are pregnant, have serious kidney problems, or have a specific heart rhythm condition that prevents proper mapping, would not be able to join. This study aims to find out which method is better for placing the wire safely and effectively in the Bachmann bundle to help improve heart function.

Gender

ALL

Eligibility criteria

  • 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

About Pugazhendhi Vijayaraman

Dr. Pugazhendhi Vijayaraman is a distinguished clinical trial sponsor with a robust background in medical research and a commitment to advancing healthcare through innovative clinical studies. With extensive experience in trial design, execution, and regulatory compliance, he plays a pivotal role in the development of novel therapies across various therapeutic areas. Dr. Vijayaraman's leadership is characterized by a dedication to enhancing patient outcomes, fostering collaborative relationships with research institutions, and adhering to the highest ethical standards in clinical research. His strategic vision and expertise contribute significantly to the advancement of medical knowledge and the improvement of patient care.

Locations

Wilkes Barre, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Pugazhendhi Vijayaraman, MD

Principal Investigator

Geisinger Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported