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NCT Number: NCT07110922

Angiography and Electrogram Guided Bachmann Bundle Pacing

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.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18711, United States

Location status: Recruiting

Location contact

Vijayaraman Pugazhendi, MD

CONTACT

[email protected]

5708086020

About this study

The ANGEL BBP study is a prospective, single-center, randomized, controlled research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the feasibility and success rates of Angiography guided Bachmann bundle pacing (BBP) lead implantation compared to traditional approach.

Eligible patients would undergo BBP using Medtronic 3830 lead and C304 or C315 family of sheaths. BBP will be confirmed at implant using Bachmann bundle potentials recorded from the lead, ECG 'P' wave morphology and duration during atrial pacing, fluoroscopic locations on right anterior oblique (RAO) and left anterior oblique (LAO) projections.

During implant procedure, 5-10 ml of contrast will be used to perform inferior superior vena cava (SVC) angiogram via the lead delivery sheath in RAO and LAO views. The pacing lead will be then implanted using these images as guidance along with recording of local electrograms from the pacing lead.

The study team will randomize 50 patients who satisfy inclusion and exclusion criteria. The study team will compare the difference in procedural success between Angiography and Electrogram guided BBP and Electrogram/ECG only guided BBP patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Success of Bachmann bundle pacing using angiography at implant

    Time frame: Perioperative

  2. Change in implant procedure duration

    Time frame: Perioperative

    Change in implant procedure duration between the two arms

Secondary outcomes

  1. Atrial pacing parameters

    Time frame: 3 month follow up

    atrial pacing parameters include threshold, sensing and impedance measured by device interrogation

  2. Paced P-wave morphology compared to native P-waves

    Time frame: 3 month follow up

    P-wave morphology is measured via ECG at follow up and compared to native P-waves from baseline ECG

  3. Paced P-wave duration compared to native P-waves

    Time frame: 3 month follow up

    P-wave duration is measured via ECG at follow up and compared to native P-waves from baseline ECG

Study contacts

Contact information is provided by the study sponsor or research team.

Pugazhendhi Vijayaraman, MD

CONTACT

[email protected]

570-808-6020

Sponsors and collaborators

Lead sponsor

Pugazhendhi Vijayaraman

Other

Collaborators

  • Medtronic

Registry information

Official study title

Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP

Acronym: (ANGEL-BBP)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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