Heart Diseases(ANGEL-BBP)NCT07110922
Angiography and Electrogram Guided Bachmann Bundle Pacing
A study testing Angiography only and Angiography and ECG in people with Heart Diseases, run by Pugazhendhi Vijayaraman at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Angiography only and Angiography and ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 26 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711
Vijayaraman Pugazhendi, MD, 5708086020, pvijayaraman1@geisinger.edu
About this study
Official title: Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP
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.
Read the detailed description
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.
- Conditions
- Heart Diseases
- Being tested
- Angiography only, Angiography and ECG
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography onlyDiagnostic test
Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region
Angiography and ECGDiagnostic test
Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region and correlate with electrogram guidance for BBP
| Study group | Role | What they receive |
|---|---|---|
| Angiography only | Experimental | Not described Receives: Diagnostic Test: Angiography only |
| Angiography and ECG | Experimental | Not described Receives: Diagnostic Test: Angiography and ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Bachmann bundle pacing using angiography at implant
Measured: Perioperative
Change in implant procedure duration
Change in implant procedure duration between the two arms
Measured: Perioperative
Secondary outcomes (3)
Atrial pacing parameters
atrial pacing parameters include threshold, sensing and impedance measured by device interrogation
Measured: 3 month follow up
Paced P-wave morphology compared to native P-waves
P-wave morphology is measured via ECG at follow up and compared to native P-waves from baseline ECG
Measured: 3 month follow up
Paced P-wave duration compared to native P-waves
P-wave duration is measured via ECG at follow up and compared to native P-waves from baseline ECG
Measured: 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start15 Aug 2025
- Primary completion26 Sep 2027 (estimated)
- Study completion26 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pugazhendhi Vijayaraman
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Pugazhendhi Vijayaraman, Geisinger Clinic
- Investigators
- Pugazhendhi Vijayaraman, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110922
- Sponsor's protocol ID
- 2025-0403
- Acronym
- (ANGEL-BBP)
- Status last verified
- Sep 2025
- First submitted
- 24 Jun 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will not be shared in an identifiable way.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiography and Electrogram Guided Bachmann Bundle Pacing - ANGEL BBP
- ClinicalTrials.gov ID
- NCT07110922
- Acronym / sponsor ID
- (ANGEL-BBP) / 2025-0403
- Conditions
- Heart Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pugazhendhi VijayaramanUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 26 Dec 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Angiography only | Experimental | Diagnostic Test: Angiography only |
| Angiography and ECG | Experimental | Diagnostic Test: Angiography and ECG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiography onlySuperior vena cava (SVC) angiogram will be used to anatomically identify the BB region | Diagnostic test | Angiography only |
| Angiography and ECGSuperior vena cava (SVC) angiogram will be used to anatomically identify the BB region and correlate with electrogram guidance for BBP | Diagnostic test | Angiography and ECG |
Primary outcome
Success of Bachmann bundle pacing using angiography at implant
Time frame: Perioperative
Change in implant procedure duration
Time frame: Perioperative
Change in implant procedure duration between the two arms
3 secondary outcomes
Atrial pacing parameters
Time frame: 3 month follow up
Paced P-wave morphology compared to native P-waves
Time frame: 3 month follow up
Paced P-wave duration compared to native P-waves
Time frame: 3 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No. Data will not be shared in an identifiable way.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pugazhendhi Vijayaraman, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiography only and Angiography and ECG in people with Heart Diseases, run by Pugazhendhi Vijayaraman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pugazhendhi Vijayaraman, MD (570-808-6020, pvijayaraman1@geisinger.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Bachmann bundle pacing using angiography at implant (time frame: Perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.