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Trial record 3 of 3 for:    resonate

Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918) (SMARTMSP)

This study is not yet open for participant recruitment.
Verified August 2017 by Boston Scientific Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT03257436
First Posted: August 22, 2017
Last Update Posted: August 22, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Condition Intervention
Left Ventricular Dysfunction Device: CRT-D

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • LV MSP feature [ Time Frame: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration. ]
    Related complication-free rate.


Estimated Enrollment: 586
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm
General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
Device: CRT-D
Left Ventricular MultiSite Pacing

Detailed Description:
Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices1 and confirm safety in a post approval study when used in accordance with its approved labeling.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed.
  2. Subjects must meet BSC labeled indication for CRT-D implantation.
  3. Subjects must have a functional RA lead and RV lead implanted
  4. Subjects who are willing and capable of providing informed consent
  5. Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
  6. Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

  1. Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
  2. Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
  3. Subjects with documented history of permanent AF
  4. Subjects with documented permanent complete AV block
  5. Subjects who are expected to receive a heart transplant during the 12 months course of the study
  6. Subjects with documented life expectancy of less than 12 months
  7. Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03257436     History of Changes
Other Study ID Numbers: 92050975
First Submitted: August 18, 2017
First Posted: August 22, 2017
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Boston Scientific Corporation:
Pacing

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases