St. Jude Medical Product Longevity and Performance (SCORE) Registry

Abbott

Status: Completed

Conditions: Bradycardia; Tachycardia; Heart Disease

Treatments: Device: Cardiac Rhythm Management device

Study type: Observational

Funder types: Industry

Identifiers

NCT01754064

40007941/F

Details and patient eligibility

About

SCORE is an active, prospective, non-randomized, multi-center outcome-oriented registry of patients implanted with St Jude Medical (SJM) market-released cardiac rhythm management (CRM) products. This registry will be conducted in the United States (US).

The primary purpose of the registry is to evaluate and publish acute and long-term performance of market-released SJM CRM products by analyzing product survival probabilities. Product status and any related adverse events will be collected to measure survival probabilities.

Enrollment: 10,957 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Enrollment Criteria:

• Patient has a standard indication for a CRM implantable device.
• Patient is implanted with at least one new market-released SJM CRM product from a list provided by SJM (e.g pacemaker, ICD, CRT-D, CRT-P, pacing/sensing lead, defibrillation lead) within the last 90 days.
• Complete system implant information (e.g. model, serial number, location) is available at enrollment.
• Any product-related adverse event information at implant is available at enrollment.
• Patient or appropriate legal guardian is willing to provide authorization for registry participation.

Trial design

10,957 participants in 1 patient group

Cardiac Rhythm Management device

Description:

Implanted with implantable defibrillator or pacemaker system

Treatment:

Device: Cardiac Rhythm Management device