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
- Are there results?
- Not yet: the study is under way
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
Show all 13Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Area Pacing (LBBAP) PMCF Study
- ClinicalTrials.gov ID
- NCT07217392
- Acronym / sponsor ID
- LBBAP PMCF / ABT-CIP-10551
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF), Cardiac Disease, Left Bundle Branch Area Pacing
- Keywords
- Right ventricular pacing, cardiac disease, heart failure, atrial fibrillation, bradycardia, left bundle branch area pacing, conduction system pacing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left Bundle Branch Area Pacing Lead Implant | Experimental | Device: LBBAP leadData 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Patient meets a standard contraindication for lead implant including:
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBBAP leadAlso: CSP leadThe 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. | Device | Left Bundle Branch Area Pacing Lead Implant |
Primary outcome
Infection Rate
Time frame: 0-6 months
Rate of Infection
Perforation Rate
Time frame: 0-6 months
Perforation includes cardiac perforation, septal perforation, coronary sinus dissection, pericardial effusion, and cardiac tamponade.
Malfunction Rate
Time frame: 0-6 months
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.
Cardiovascular Injury Rate
Time frame: 0-6 months
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).
Implant success rate
Time frame: At the time of implant
Rate of Implant success of LBBAP lead
Lead dislodgement rate
Time frame: 0-6 months
Rate of LBBAP lead dislodgement
Pacing threshold
Time frame: 0-6 months
Measure of minimum electrical energy required to stimulate and depolarize
Impedence
Time frame: 0-6 months
Measure of lead impedance
Sensing Amplitude
Time frame: 0-6 months
Measure of lead sensing amplitude
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Bradycardia
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
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BIO|STREAM.CSP Study
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BIO|MASTER.CSP Study
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Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
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Not yet recruiting
Belgo-Luxembourg Leadless PM Registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LBBAP lead in people with Bradycardia and Right Ventricular Pacing, run by Abbott Medical Devices at 15 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in India, Brazil, Singapore, France, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Scientist (+17472450158, trisha.satish@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection Rate (time frame: 0-6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.