Clinical trial NCT05887323: LBBAP Data Collection Registry
Official title: Left Bundle Branch Area Pacing (LBBAP) Data Collection Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Sinus Node Dysfunction
Heart Block
Syncope
Cardiomyopathies
Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an attempted LBBA implant with Abbott's Tendril 2088 lead

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs).
timeFrame: 6 months after the implantation
measure: The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP
timeFrame: 6 months after the implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Pensacola
country: United States
facility: Cardiology Consultants - Baptist Campus
state: Florida
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Marseille
country: France
facility: Hopital d'adulte de la Timone
state: Alpes
city: Gurgaon
country: India
facility: Medanta - The Medicity Hospital
state: Nct Dlh
city: Chennai
country: India
facility: The Madras Medical Mission
state: Tamilnadu
city: Rovigo
country: Italy
facility: Ospedale S.Maria della Misericordia
state: Veneto
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Abbott
name: Kwangdeok Lee
role: STUDY_DIRECTOR
References: