RecruitingNot ApplicableNCT07217392

Left Bundle Branch Area Pacing (LBBAP) PMCF Study


Sponsor

Abbott Medical Devices

Enrollment

200 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is following patients who have had a special type of pacemaker lead implanted called a Left Bundle Branch Area Pacing (LBBAP) lead. This lead is placed deeper in the heart's electrical system than traditional leads, and researchers want to track how well it works and how safe it is over time. **You may be eligible if...** - You are 18 or older and have recently had a compatible LBBAP pacemaker lead implanted, as recommended by your doctor - You are willing to attend follow-up visits and comply with study procedures **You may NOT be eligible if...** - You have certain heart valve abnormalities (like tricuspid atresia or a mechanical tricuspid valve) - You are sensitive to the anti-inflammatory medication used in the lead - You already have a pacemaker, ICD, or CRT device - You had a previous failed attempt to place a lead in the left bundle branch area - You are scheduled for another heart procedure or transplant within 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICELBBAP 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.


Locations(13)

Instituto Nacional de Cardiologia (INC)

Rio de Janeiro, Rio de Janeiro, Brazil

Instituto do Coracao (InCor) - HCFMUSP

São Paulo, São Paulo, Brazil

Hopital d'adulte de la Timone

Marseille, Alpes, France

Kerckhoff-Klinik gGmbH

Bad Nauheim, Hesse, Germany

Narayana Institute of Cardiac Sciences, Bommasandra

Bangalore, Karnakt, India

Fortis Escorts Heart Institute

New Delhi, National Capital Territory of Delhi, India

Vardhman Mahavir Medical College & Safdarjung Hospital

New Delhi, National Capital Territory of Delhi, India

Meenakshi Mission Hospital & Research Centre

Madurai, Tamil Nadu, India

Manipal Hospital E.M. Bypass

Kolkata, West Bengal, India

Institut Jantung Negara

Kuala Lumpur, Cmalays, Malaysia

Tan Tock Seng Hospital

Singapore, Central, Singapore

Changi General Hospital

Singapore, Central, Singapore

Hospital Universitario Doce de Octubre

Madrid, Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07217392


Related Trials