Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT03075215

Run by

Boston Scientific Corporation

People needed

2044

Starts

2017-04-14

Expected to finish

2021-11-15

Last updated by the study team

2023-10-25

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CardioVascular Associates of Mesa — Mesa, Arizona, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Comprehensive Cardiovascular Medical Group — Bakersfield, California, United States
• VA Loma Linda Healthcare System — Loma Linda, California, United States
• Western Connecticut Health Network/ Danbury Hospital — Danbury, Connecticut, United States
• Bay Area Cardiology Associates, P.A. — Brandon, Florida, United States
• North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States
• Northeast Georgia Heart Center — Gainesville, Georgia, United States
• The University of Illinois Medical Center — Chicago, Illinois, United States
• Riverside Medical Center / Midwest Arrhythmia Consultants — Kankakee, Illinois, United States
• Ball Memorial Hospital — Muncie, Indiana, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• Cardiovascular Institute of the South — Lafayette, Louisiana, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Peninsula Cardiology Associates — Salisbury, Maryland, United States
• Hurley Medical Center — Flint, Michigan, United States
• Summit Medical Group, P.A. — Berkeley Heights, New Jersey, United States
• Trinity Medical WNY,PC — Buffalo, New York, United States
• Columbia. University Medical Center/ NY Presbyterian Hospital — New York, New York, United States
• New Hanover Regional Medical Center — Wilmington, North Carolina, United States
• St. Alexius Medical Center — Bismarck, North Dakota, United States
• Kettering Medical Center — Kettering, Ohio, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Regional Cardiac Arrythmia — Washington, Pennsylvania, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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