LBBAP Data Collection Registry

Heart Failure Clinical Trial

Official title:

Left Bundle Branch Area Pacing (LBBAP) Data Collection Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05887323
• Other study ID #: ABT-CIP-10474
• Status: Active, not recruiting
• Start date: April 25, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 221
• Est. completion date: March 31, 2024
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Cardiomyopathies
• Heart Block
• Heart Failure
• Sick Sinus Syndrome
• Sinus Node Dysfunction
• Syncope

Intervention

Device:
• Implantation of the Tendril 2088 lead in the LBBA
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.

Locations

Country	Name	City	State
France	Hopital d'adulte de la Timone	Marseille	Alpes
India	The Madras Medical Mission	Chennai	Tamilnadu
India	Medanta - The Medicity Hospital	Gurgaon	Nct Dlh
Italy	Ospedale S.Maria della Misericordia	Rovigo	Veneto
Singapore	National Heart Centre Singapore	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Cardiology Consultants - Baptist Campus	Pensacola	Florida
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	North Mississippi Medical Center	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  France,  India,  Italy,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	6 months after the implantation