LBBAP Data Collection Registry

NCT05887323 | Completed Results FDA Device

• 1 other identifier: ABT-CIP-10474
• Study Type: observational
• Target: 221
• Locations: 5 countries
• Sites: 11

Brief Summary

The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.

Conditions

Bradycardia; Sinus Node Dysfunction; Heart Block; Syncope; Cardiomyopathies; Heart Failure

Outcome Measures

Primary Outcomes (2)

• The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs).

  The primary safety endpoint evaluates a LBBAP lead related SADE rate which is an appropriate measure for safety and consistent with the primary safety endpoints used for evaluating performance of the transvenous right ventricular lead.

  6 months after the implantation

• The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP

  The primary effectiveness endpoint evaluates the ability to pace and sense when the TendrilTM STS 2088 lead is implanted in the LBBA. This analysis was performed on the successfully implanted population.

  6 months after the implantation

Study Arms (1)

Left Bundle Branch Area Implant

Data included in this LBBAP data collection registry will be from subjects followed for 6 months (± 3 months) after attempted implant of LBBAP location. Data will be collected from previously occurring visits at pre-implant (baseline, required), implant (required), 6 months (±3 months, required), and 12 months (-2, +4months, optional).

Device: Implantation of the Tendril 2088 lead in the LBBA

Interventions

Implantation of the Tendril 2088 lead in the LBBA DEVICE

Conduction system pacing is achieved by delivering a pacing stimulus to the Left Bundle Branch area of the heart with Abbott's Tendril 2088 lead.

Left Bundle Branch Area Implant

Eligibility Criteria

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

Study Population

Patients with an attempted LBBA implant with Abbott's Tendril 2088 lead

You may qualify if:

• Subject has a de novo attempted implant of the TendrilTM STS 2088 lead in the Left Bundle Branch Area on or before January 31, 2023 and subject's medical records contain data through at least 6 months (+/- 3 months) after LBBAP implant attempt
• Subject is ≥ 18 years of age or the legal age, whichever age is greater

You may not qualify if:

• \. Subject was enrolled in another clinical trial during this data collection period that might impact the outcomes of the present registry

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (11)

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Cardiology Consultants - Baptist Campus

Pensacola, Florida, 32501, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2150, United States

Location

Hopital d'adulte de la Timone

Marseille, Alpes, 13005, France

Location

Medanta - The Medicity Hospital

Gūrgaon, NCT DLH, 122001, India

Location

The Madras Medical Mission

Chennai, Tamil Nadu, 600037, India

Location

Ospedale S.Maria della Misericordia

Rovigo, Veneto, 45100, Italy

Location

National Heart Centre Singapore

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Bradycardia; Sick Sinus Syndrome; Heart Block; Syncope; Cardiomyopathies; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmia, Sinus; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Abbott

kwangdeok.lee@abbott.com

9725269673

Study Officials

• Kwangdeok Lee

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: June 2, 2023
• Study Start: April 25, 2023
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-07

Locations

IT (1); SG (2); US (5); FR (1); IN (2)