LBBAP Data Collection Registry

Completed

Conditions studied: Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope, Cardiomyopathies, Heart Failure

In brief

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.

Key facts

Study ID

NCT05887323

Run by

Abbott Medical Devices

People needed

221

Starts

2023-04-25

Expected to finish

2023-07-11

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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)

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

Where it is running

• 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, Tamil Nadu, India
• Ospedale S.Maria della Misericordia — Rovigo, Veneto, Italy
• National Heart Centre Singapore — Singapore, Singapore
• Tan Tock Seng Hospital — Singapore, Singapore

Full record on ClinicalTrials.gov

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