Left Bundle Branch Area Pacing (LBBAP) PMCF Study (LBBAP PMCF)

Abbott

Status: Enrolling

Conditions: Bradycardia; Conduction System Pacing; Cardiac Disease; Left Bundle Branch Area Pacing; Atrial Fibrillation (AF); Heart Failure; Right Ventricular Pacing

Treatments: Device: LBBAP lead

Study type: Interventional

Funder types: Industry

Identifiers

NCT07217392

ABT-CIP-10551

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area
2. Are ≥ 18 years of age or age of legal consent, whichever age is greater.
3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
4. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.

Exclusion criteria

1. Patient meets a standard contraindication for lead implant including:

   1. the presence of tricuspid atresia
   2. patients with mechanical tricuspid valves
   3. patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate

2. Patient is currently implanted with a pacemaker, ICD, or CRT-D/P device

3. Patient has had a previous unsuccessful attempt to place a lead in the LBB area

4. Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant

5. Patient is expected to receive a heart transplant within 6 months

6. Patient life expectancy less than 6 months

7. Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder

8. Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study

9. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.

10. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Left Bundle Branch Area Pacing Lead Implant

Experimental group

Description:

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.

Treatment:

Device: LBBAP lead