Trials / Recruiting
RecruitingNCT07217392
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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).
Conditions
- Bradycardia
- Right Ventricular Pacing
- Heart Failure
- Atrial Fibrillation (AF)
- Cardiac Disease
- Left Bundle Branch Area Pacing
- Conduction System Pacing
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LBBAP lead | 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. |
Timeline
- Start date
- 2025-07-24
- Primary completion
- 2027-04-30
- Completion
- 2027-04-30
- First posted
- 2025-10-16
- Last updated
- 2025-10-16
Locations
2 sites across 1 country: India
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07217392. Inclusion in this directory is not an endorsement.