BradycardiaLBBAP PMCFNCT07217392
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
A study testing LBBAP lead in people with Bradycardia and Right Ventricular Pacing, run by Abbott Medical Devices at 15 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Right Ventricular Pacing, Heart Failure
- What is being tested?
- LBBAP lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 15 sitesin 9 countries
- Study dates
- 24 Jul 2025to 30 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area
- Are ≥ 18 years of age or age of legal consent, whichever age is greater.
- Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
- Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.
Who cannot join
- Patient meets a standard contraindication for lead implant including:
- the presence of tricuspid atresia
- patients with mechanical tricuspid valves
- patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate
- Patient is currently implanted with a pacemaker, ICD, or CRT-D/P device
- Patient has had a previous unsuccessful attempt to place a lead in the LBB area
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- Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
- Patient is expected to receive a heart transplant within 6 months
- Patient life expectancy less than 6 months
- Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
- Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation.
Trial locations and contacts
15 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 9 countries
India5 sites, 5 recruiting
- Recruiting
Narayana Institute of Cardiac Sciences, Bommasandra
Bangalore, Karnakt, 560099
Rani Punitha, punitha.i@narayanahealth.org
Kapil Kumawat
- Recruiting
Manipal Hospital E.M. Bypass
Kolkata, West Bengal, 700099
Shirshendu Debnath, shirshendu.debnath@manipalhospitals.com
Dilip Kumar
- Recruiting
Meenakshi Mission Hospital & Research Centre
Madurai, Tamil Nadu, 625107
Research Coordinator, 919489594257, palanikumar@mmhrc.com
P Jayapandian
- Recruiting
Fortis Escorts Heart Institute
New Delhi, National Capital Territory of Delhi, 110025
Research Coordinator, 919911588350, cl.researchfehi3@fortishealthcare.com
Aparna Jaswal
- Recruiting
Vardhman Mahavir Medical College & Safdarjung Hospital
New Delhi, National Capital Territory of Delhi, 110029
Raj K Bipin, 918904472442, rajbipin91@gmail.com
Isser Hermohander Singh
Brazil2 sites, 2 recruiting
- Not yet recruiting
Instituto Nacional de Cardiologia (INC)
Rio de Janeiro, Rio de Janeiro, 22240-006
Helena Rey, helena.rey@inc.saude.gov.br
Rodrigo Minati Barbosa
- Not yet recruiting
Instituto do Coracao (InCor) - HCFMUSP
São Paulo, São Paulo, 05403-000
Amanda Alves de Brito, amanda.abrito@hc.fm.usp.br
Martino Martinelli Filho
Singapore2 sites, 2 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, Central, 308433
Sheau Tyug Wong, 6598322330, Sheau_Tyug_WONG@ttsh.com.sg
David Chee Guan Foo
- Recruiting
Changi General Hospital
Singapore, Central, 529889
Genevieve Pan Jing Wen, genevieve.pan.j.w@cgh.com.sg
Vern Hsen Tan
France1 site, 1 recruiting
- Recruiting
Hopital d'adulte de la Timone
Marseille, Alpes, 13005
Caroline Brunet, +33491387797, caroline.brunet@ap-hm.fr
Jean-Claude Deharo
Germany1 site, 1 recruiting
- Recruiting
Kerckhoff-Klinik gGmbH
Bad Nauheim, Hesse, 61231
Annerose Peil, a.peil@kerckhoff-klinik.de
Andreas Hain
Italy1 site, 1 recruiting
- Recruiting
Az.Osp. Universitaria di Ferrara
Cona, Emi-rom, 44124
Elisa Mosele, 390532237227, elisa21mosele@gmail.com
Matteo Bertini
Malaysia1 site, 1 recruiting
- Recruiting
Institut Jantung Negara
Kuala Lumpur, Cmalays, 50400
Lydia Yati Munir, lydiayati@ijn.com.my
Azlan Hussin
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Doce de Octubre
Madrid, Madrid, 28041
Sofia Barbado Nieto, sofia.barbado.imas12@h12o.es
Luis Borrego Bernabe
United Arab Emirates1 site, 1 recruiting
- Recruiting
Cleveland Clinic Abu Dhabi
Abu Dhabi, ABU DBI
John Rickard, +971 800 82223, rickarj@ccad.ae
About this study
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.
Read the detailed description
The Left Bundle Branch Area Pacing (LBBAP) Post-Market Clinical Follow-up (PMCF) Study is a global, prospective, single-arm, multi-center trial conducted to support an indication expansion of the Tendril STS (model 2088TC) and UltiPace (model LPA1231) leads to include pacing/sensing in the left bundle branch area (LBBA).
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF), Cardiac Disease, Left Bundle Branch Area Pacing
- Being tested
- LBBAP lead
- Keywords
- Right ventricular pacing, cardiac disease, heart failure, atrial fibrillation, bradycardia, left bundle branch area pacing, conduction system pacing
- Medical subject headings
- Bradycardia, Heart Failure, Atrial Fibrillation, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBBAP leadDevice
Also called CSP 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.
| Study group | Role | What they receive |
|---|---|---|
| Left Bundle Branch Area Pacing Lead Implant | Experimental | Data will be collected from patients implanted with either the Tendril STS 2088TC or UltiPace LPA1231 lead in the left bundle branch area for pacing and sensing from implant through 6 months. Leads are indicated for use in combination with a compatible pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device. Receives: Device: LBBAP lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Rate
Rate of Infection
Measured: 0-6 months
Perforation Rate
Perforation includes cardiac perforation, septal perforation, coronary sinus dissection, pericardial effusion, and cardiac tamponade.
Measured: 0-6 months
Malfunction Rate
Malfunction includes 1) mechanical lead failure including lead insulation issues, lead fracture, and other lead damage, dysfunction, helix damage or fracture; malfunction or failure; and 2) electrical abnormalities of unknown cause including sensing issues, pacing issues, loss of capture, impedance abnormality, and noise; 3) excludes infection, perforation or dislodgement caused inappropriate therapy.
Measured: 0-6 months
Cardiovascular Injury Rate
Cardiovascular Injury is a safety measure specific to LBBAP leads and includes Acute coronary syndrome; Coronary artery fistula; Coronary vein fistula/injury and Septal hematoma. This parameter also includes the right bundle branch block and complete heart block (permanent).
Measured: 0-6 months
Implant success rate
Rate of Implant success of LBBAP lead
Measured: At the time of implant
Lead dislodgement rate
Rate of LBBAP lead dislodgement
Measured: 0-6 months
Pacing threshold
Measure of minimum electrical energy required to stimulate and depolarize
Measured: 0-6 months
Impedence
Measure of lead impedance
Measured: 0-6 months
Sensing Amplitude
Measure of lead sensing amplitude
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start24 Jul 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217392
- Sponsor's protocol ID
- ABT-CIP-10551
- Acronym
- LBBAP PMCF
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No