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This clinical investigation is a prospective, single-arm, post-market, non-randomized, single-center study designed to evaluate the effectiveness of the SyncAV CRT dynamic atrioventricular (AV) delay feature when used with left bundle branch area pacing (LBBAP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBBAP with SyncAV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBBAP with SyncAV | Device | Acute changes in surface ECG QRS duration resulting from left bundle branch area pacing using various pacing configurations will be evaluated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| QRS duration | Acute change in surface ECG QRS duration resulting from left bundle branch area pacing with optimized SyncAV, relative to intrinsic atrioventricular conduction. | During the intervention/procedure/surgery |
| Measure | Description | Time Frame |
|---|---|---|
| LV hemodynamics | Acute change in left ventricular hemodynamics (i.e., maximum rise in pressure) resulting from left bundle branch area pacing with optimized SyncAV, relative to intrinsic atrioventricular conduction. | During the intervention/procedure/surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy, with documented left bundle branch block or intraventricular conduction delay, long QRS duration, and intact AV conduction will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nima Badie, PhD | Contact | 408-702-8604 | nima.badie@abbott.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.R.C.C.S. Policlinico San Donato | Recruiting | San Donato Milanese | MI | 20097 | Italy |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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