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Left Bundle Branch Area Pacing (LBBAP) PMCF Study

NCT07217392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • Brazil
  • France
  • Germany
  • India
  • Malaysia
  • Singapore
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217392 on ClinicalTrials.gov