Left Bundle Branch Area Pacing (LBBAP) PMCF Study

NCT07217392 | Recruiting FDA Device

• 1 other identifier: ABT-CIP-10551
• Study Type: interventional
• Target: 200
• Locations: 7 countries
• Sites: 13

Brief 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.

Conditions

Right Ventricular Pacing; Heart Failure; Atrial Fibrillation (AF); Cardiac Disease; Left Bundle Branch Area Pacing; Conduction System Pacing; Bradycardia

Keywords

Right ventricular pacing; cardiac disease; heart failure; atrial fibrillation; bradycardia; left bundle branch area pacing; conduction system pacing

Outcome Measures

Primary Outcomes (9)

• Infection Rate

  Rate of Infection

  0-6 months

• Perforation Rate

  Perforation includes cardiac perforation, septal perforation, coronary sinus dissection, pericardial effusion, and cardiac tamponade.

  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.

  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).

  0-6 months

• Implant success rate

  Rate of Implant success of LBBAP lead

  At the time of implant

• Lead dislodgement rate

  Rate of LBBAP lead dislodgement

  0-6 months

• Pacing threshold

  Measure of minimum electrical energy required to stimulate and depolarize

  0-6 months

• Impedence

  Measure of lead impedance

  0-6 months

• Sensing Amplitude

  Measure of lead sensing amplitude

  0-6 months

Study Arms (1)

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.

Device: LBBAP lead

Interventions

LBBAP lead DEVICE

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.

Also known as: CSP lead

Left Bundle Branch Area Pacing Lead Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (13)

Instituto Nacional de Cardiologia (INC)

Rio de Janeiro, Rio de Janeiro, 22240-006, Brazil

NOT YET RECRUITING

Instituto do Coracao (InCor) - HCFMUSP

São Paulo, São Paulo, 05403-000, Brazil

NOT YET RECRUITING

Hopital d'adulte de la Timone

Marseille, Alpes, 13005, France

RECRUITING

Kerckhoff-Klinik gGmbH

Bad Nauheim, Hesse, 61231, Germany

NOT YET RECRUITING

Narayana Institute of Cardiac Sciences, Bommasandra

Bangalore, Karnakt, 560099, India

RECRUITING

Fortis Escorts Heart Institute

New Delhi, National Capital Territory of Delhi, 110025, India

RECRUITING

Vardhman Mahavir Medical College & Safdarjung Hospital

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Meenakshi Mission Hospital & Research Centre

Madurai, Tamil Nadu, 625107, India

RECRUITING

Manipal Hospital E.M. Bypass

Kolkata, West Bengal, 700099, India

NOT YET RECRUITING

Institut Jantung Negara

Kuala Lumpur, Cmalays, 50400, Malaysia

NOT YET RECRUITING

Tan Tock Seng Hospital

Singapore, Central, 308433, Singapore

RECRUITING

Changi General Hospital

Singapore, Central, 529889, Singapore

NOT YET RECRUITING

Hospital Universitario Doce de Octubre

Madrid, Madrid, 28041, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Bradycardia; Heart Failure; Atrial Fibrillation; Heart Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Research Scientist

CONTACT

+17472450158; trisha.satish@abbott.com

Clinical Project Manager

CONTACT

+16517565602; stacy.scribner@abbott.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 16, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DE (1); BR (2); FR (1); SG (2); MY (1); IN (5)