Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiography only | Experimental |
| |
| Angiography and ECG | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiography only | Diagnostic Test | Superior vena cava (SVC) angiogram will be used to anatomically identify the BB region |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial pacing parameters | atrial pacing parameters include threshold, sensing and impedance measured by device interrogation | 3 month follow up |
| Paced P-wave morphology compared to native P-waves |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pugazhendhi Vijayaraman, MD | Contact | 570-808-6020 | pvijayaraman1@geisinger.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pugazhendhi Vijayaraman, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Wyoming Valley | Recruiting | Wilkes-Barre | Pennsylvania | 18711 | United States |
Data will not be shared in an identifiable way.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000792 | Angiography |
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| 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 |
|
P-wave morphology is measured via ECG at follow up and compared to native P-waves from baseline ECG
| 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 | 3 month follow up |
| D003935 |
| Diagnostic Techniques, Cardiovascular |
| D006334 | Heart Function Tests |
| D004568 | Electrodiagnosis |