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Left Bundle Branch Area Pacing (LBBAP) PMCF Study
Sponsor: Abbott Medical Devices
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-07-24
Completion Date
2027-04-30
Last Updated
2026-04-24
Healthy Volunteers
No
Conditions
Interventions
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.
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