Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)

Boston Scientific

Status: Completed

Conditions: Heart Failure

Treatments: Device: Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Study type: Observational

Funder types: Industry

Identifiers

NCT03075215

C1949

Details and patient eligibility

About

To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others.

A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.

Enrollment: 2,044 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject implanted or upgraded with a NG3 or NG4 CRT-D device connected with any manufacturer quadripolar LV lead based on BSC labeling for devices in specific geographies.
• Subjects must be enrolled between 1 and 21 calendar days post CRT-D implantation procedure.
• Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
• Subject is willing and capable of complying with follow-up visits and procedures as defined by this protocol

Exclusion criteria

• Subject with documented life expectancy of less than 12 months
• Subject currently on the active heart transplant list or has a current Left Ventricular Assist Device or other assist device (mechanical circulatory support device).
• Subject who have had a pre-existing CRT device
• Subject enrolled in any other concurrent clinical trial without prior written approval from BSC Clinical Trial Manager
• Women of childbearing potential who are or might be pregnant at time of study enrolment
• Any contra-indication to receive a CRT-D device per local guidelines

Trial design