LBBAP Data Collection Registry

Completed

• Conditions: Bradycardia; Cardiomyopathies; Heart Block; Heart Failure; Syncope; Sinus Node Dysfunction

• Registration Number: NCT05887323
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

This registry is a retrospective, observational, non-controlled chart review conducted to support an indication expansion of the Tendril STS 2088 lead to include pacing/sensing in the left bundle branch area.

Data from a minimum of 220 attempted subjects will be included in order to have 190 evaluable subjects in this registry. The chart review will be conducted at up to 20 participating centers worldwide.

Study Timeline

• Study Start: 2023-04-25
• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-02
• Primary Completion: 2023-07-11
• Study Completion: 2023-07-11
• Status Verified: 2024-07
• Results First Submitted: 2024-07-08
• Results First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Results First Posted: 2024-10-07
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

1. 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
2. Subject is ≥ 18 years of age or the legal age, whichever age is greater
3. For sites where the governing IRB/EC has not granted a waiver of informed consent, subject has either been informed of the nature of the clinical investigation using a privacy notice or has provided a signed written informed consent, as approved by the IRB/EC (Note: This inclusion criterion is not applicable for sites where the governing IRB/EC or applicable regulation has granted a waiver of patient consent)

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs).	6 months after the implantation	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.
The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP	6 months after the implantation	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.

Trial Locations

Locations (11)

Arrhythmia Research Group; 🇺🇸 Jonesboro, Arkansas, United States

Eisenhower Medical Center; 🇺🇸 Rancho Mirage, California, United States

Cardiology Consultants - Baptist Campus; 🇺🇸 Pensacola, Florida, United States

North Mississippi Medical Center; 🇺🇸 Tupelo, Mississippi, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Hopital d'adulte de la Timone; 🇫🇷 Marseille, Alpes, France

Medanta - The Medicity Hospital; 🇮🇳 Gurgaon, Nct Dlh, India

The Madras Medical Mission; 🇮🇳 Chennai, Tamilnadu, India

Ospedale S.Maria della Misericordia; 🇮🇹 Rovigo, Veneto, Italy

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore

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