Actively Recruiting
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
Led by Abbott Medical Devices · Updated on 2026-04-24
200
Participants Needed
13
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets current clinical guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area
- 18 years of age or older (or age of legal consent)
- Willing to comply with clinical procedures and attend all follow-up visits
- Provided signed informed consent approved by an ethics committee
You will not qualify if you...
- Presence of tricuspid atresia
- Mechanical tricuspid valve present
- Hypersensitivity to dexamethasone sodium phosphate
- Currently implanted with pacemaker, ICD, or CRT-D/P device
- Previous unsuccessful lead placement attempt in left bundle branch area
- Planned cardiac surgery or interventions within 3 months after implant
- Expected heart transplant within 6 months
- Life expectancy less than 6 months
- Presence of other life-threatening illness apart from cardiac disorder
- Enrolled or planning to enroll in another conflicting clinical trial
- Pregnant, nursing, or planning pregnancy during study follow-up
- Other medical, social, or psychological conditions limiting ability to participate or comply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Instituto Nacional de Cardiologia (INC)
Rio de Janeiro, Rio de Janeiro, Brazil, 22240-006
Not Yet Recruiting
2
Instituto do Coracao (InCor) - HCFMUSP
São Paulo, São Paulo, Brazil, 05403-000
Not Yet Recruiting
3
Hopital d'adulte de la Timone
Marseille, Alpes, France, 13005
Actively Recruiting
4
Kerckhoff-Klinik gGmbH
Bad Nauheim, Hesse, Germany, 61231
Not Yet Recruiting
5
Narayana Institute of Cardiac Sciences, Bommasandra
Bangalore, Karnakt, India, 560099
Actively Recruiting
6
Fortis Escorts Heart Institute
New Delhi, National Capital Territory of Delhi, India, 110025
Actively Recruiting
7
Vardhman Mahavir Medical College & Safdarjung Hospital
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
8
Meenakshi Mission Hospital & Research Centre
Madurai, Tamil Nadu, India, 625107
Actively Recruiting
9
Manipal Hospital E.M. Bypass
Kolkata, West Bengal, India, 700099
Not Yet Recruiting
10
Institut Jantung Negara
Kuala Lumpur, Cmalays, Malaysia, 50400
Not Yet Recruiting
11
Tan Tock Seng Hospital
Singapore, Central, Singapore, 308433
Actively Recruiting
12
Changi General Hospital
Singapore, Central, Singapore, 529889
Not Yet Recruiting
13
Hospital Universitario Doce de Octubre
Madrid, Madrid, Spain, 28041
Not Yet Recruiting
Research Team
C
Clinical Research Scientist
CONTACT
C
Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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