Actively Recruiting
Left Bundle Branch Area Pacing (LBBAP) Post-Market Clinical Follow-up Study Evaluating Tendril STS 2088TC and UltiPace LPA1231 Leads
Led by Abbott Medical Devices · Updated on 2026-04-24
200
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of left bundle branch area (LBBA) pacing and sensing in patients who have been implanted with either the Tendril STS 2088TC or UltiPace LPA1231 pacing leads. This trial is a global, prospective, single-arm, multi-center study designed to support expanding the approved use of these leads to include pacing and sensing specifically in the LBBA. The study focuses on patients with various cardiac conditions such as bradycardia, heart failure, atrial fibrillation, and conduction system pacing. The study involves implanting the Tendril STS 2088TC or UltiPace LPA1231 leads in the LBBA for pacing and sensing. These are bipolar, steroid-eluting, active fixation, MR Conditional leads that can also be placed in other heart chambers but are being evaluated here specifically for the LBBA location. The leads are used with compatible pacemakers, implantable cardioverter defibrillators, or cardiac resynchronization therapy devices. Data will be collected from the time of implant through six months post-implant. Participants will have scheduled follow-up visits during the six months after implantation to monitor device performance and patient safety. Researchers will assess outcomes such as infection rate, lead malfunction, cardiovascular injury, implant success, lead dislodgement, pacing threshold, impedance, and sensing amplitude. Participants must comply with study procedures and return for all required visits, tests, and exams. The study duration for each participant is six months after implant.
CONDITIONS
Brief Title
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets current clinical practice 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, whichever is greater
- Willing to comply with all clinical investigation procedures and follow-up visits
- Provided signed informed consent approved by the Institutional Review Board or Ethics Committee
You will not qualify if you...
- Presence of tricuspid atresia
- Mechanical tricuspid valve
- Hypersensitivity to dexamethasone sodium phosphate
- Currently implanted with a pacemaker, ICD, or CRT device
- Previous unsuccessful attempt to place a lead in the 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 separate from cardiac disorder
- Enrolled or planning to enroll in another clinical trial that may affect results
- Pregnant, nursing, or planning pregnancy during the study follow-up
- Other medical, social, or psychological conditions limiting participation or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - At the time of implant
Participants undergo implantation of the Tendril STS 2088TC or UltiPace LPA1231 lead in the left bundle branch area for pacing and sensing.
1 implantation visit (in-person)
Duration - Up to 6 months
Participants are followed for safety and device performance for up to 6 months after implantation.
Multiple follow-up visits during the 6 months
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
C
Clinical Project Manager
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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