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The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
The Left Bundle Branch Area Pacing (LBBAP) Post-Market Clinical Follow-up (PMCF) Study is a global, prospective, single-arm, multi-center trial conducted to support an indication expansion of the Tendril STS (model 2088TC) and UltiPace (model LPA1231) leads to include pacing/sensing in the left bundle branch area (LBBA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left Bundle Branch Area Pacing Lead Implant | Experimental | Data will be collected from patients implanted with either the Tendril STS 2088TC or UltiPace LPA1231 lead in the left bundle branch area for pacing and sensing from implant through 6 months. Leads are indicated for use in combination with a compatible pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBBAP lead | Device | The lead is bipolar, steroid-eluting, active fixation, MR Conditional, implantable pacing leads that can be placed in the right atrium, right ventricle, or left bundle branch area for pacing and sensing. |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rate | Rate of Infection | 0-6 months |
| Perforation Rate | Perforation includes cardiac perforation, septal perforation, coronary sinus dissection, pericardial effusion, and cardiac tamponade. | 0-6 months |
| Malfunction Rate | Malfunction includes 1) mechanical lead failure including lead insulation issues, lead fracture, and other lead damage, dysfunction, helix damage or fracture; malfunction or failure; and 2) electrical abnormalities of unknown cause including sensing issues, pacing issues, loss of capture, impedance abnormality, and noise; 3) excludes infection, perforation or dislodgement caused inappropriate therapy. | 0-6 months |
| Cardiovascular Injury Rate | Cardiovascular Injury is a safety measure specific to LBBAP leads and includes Acute coronary syndrome; Coronary artery fistula; Coronary vein fistula/injury and Septal hematoma. This parameter also includes the right bundle branch block and complete heart block (permanent). | 0-6 months |
| Implant success rate | Rate of Implant success of LBBAP lead | At the time of implant |
| Lead dislodgement rate | Rate of LBBAP lead dislodgement | 0-6 months |
| Pacing threshold | Measure of minimum electrical energy required to stimulate and depolarize |
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Inclusion Criteria:
Exclusion Criteria:
Patient meets a standard contraindication for lead implant including:
Patient is currently implanted with a pacemaker, ICD, or CRT-D/P device
Patient has had a previous unsuccessful attempt to place a lead in the LBB area
Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
Patient is expected to receive a heart transplant within 6 months
Patient life expectancy less than 6 months
Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Contact | +17472450158 | trisha.satish@abbott.com | |
| Clinical Project Manager | Contact | +16517565602 | stacy.scribner@abbott.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Cardiologia (INC) | Not yet recruiting | Rio de Janeiro | Rio de Janeiro | 22240-006 | Brazil |
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|
| 0-6 months |
| Impedence | Measure of lead impedance | 0-6 months |
| Sensing Amplitude | Measure of lead sensing amplitude | 0-6 months |
| Instituto do Coracao (InCor) - HCFMUSP | Not yet recruiting | São Paulo | São Paulo | 05403-000 | Brazil |
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| Hopital d'adulte de la Timone | Recruiting | Marseille | Alpes | 13005 | France |
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| Kerckhoff-Klinik gGmbH | Not yet recruiting | Bad Nauheim | Hesse | 61231 | Germany |
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| Narayana Institute of Cardiac Sciences, Bommasandra | Recruiting | Bangalore | Karnakt | 560099 | India |
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| Fortis Escorts Heart Institute | Recruiting | New Delhi | National Capital Territory of Delhi | 110025 | India |
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| Vardhman Mahavir Medical College & Safdarjung Hospital | Recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
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| Meenakshi Mission Hospital & Research Centre | Recruiting | Madurai | Tamil Nadu | 625107 | India |
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| Manipal Hospital E.M. Bypass | Not yet recruiting | Kolkata | West Bengal | 700099 | India |
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| Institut Jantung Negara | Not yet recruiting | Kuala Lumpur | Cmalays | 50400 | Malaysia |
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| Tan Tock Seng Hospital | Recruiting | Singapore | Central | 308433 | Singapore |
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| Changi General Hospital | Not yet recruiting | Singapore | Central | 529889 | Singapore |
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| Hospital Universitario Doce de Octubre | Not yet recruiting | Madrid | Madrid | 28041 | Spain |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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