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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03075215
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:

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 or disease Intervention/treatment
Heart Failure Device: Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 2044 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)
Actual Study Start Date : April 14, 2017
Actual Primary Completion Date : November 15, 2021
Actual Study Completion Date : November 15, 2021
Groups and Cohorts
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Intervention Details:
  • Device: Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)
    The optimization during the standard of care visits in the first 12 months following implantation

Outcome Measures
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Primary Outcome Measures :
  1. CRT Response Rate [ Time Frame: 12 months ]
    Clinical Composite Score


Secondary Outcome Measures :
  1. NG4 PG Related Complication Free rate [ Time Frame: 36 months ]
    Complication Free rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects implanted with a quadripolar NG3 or NG4 CRT-D device in conjunction with a quadripolar lead from any manufacturer will be selected based on the inclusion/exclusion criteria
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075215


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Jose-Ignacio Garcia-Bolao, PhD, FESC Clinica Universidad de Navarra
More Information
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Additional Information:

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03075215    
Other Study ID Numbers: C1949
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases