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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Other
Time Perspective
Prospective

Recruiting Locations

More Details

NCT ID
NCT03075215
Status
Completed
Sponsor
Boston Scientific Corporation

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center