Status:
COMPLETED
Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Left Ventricular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, multi-center, single arm, post approval study to be conducted in the United States.
Detailed Description
Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used...
Eligibility Criteria
Inclusion
- 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.
- Subjects must meet BSC labeled indication for CRT-D implantation.
- Subjects must have a functional RA lead and RV lead implanted
- Subjects who are willing and capable of providing informed consent
- 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
- Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law
Exclusion
- Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation.
- Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment
- Subjects with documented history of permanent AF
- Subjects with documented permanent complete AV block
- Subjects who are expected to receive a heart transplant during the 12 months course of the study
- Subjects with documented life expectancy of less than 12 months
- 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
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2020
Estimated Enrollment :
586 Patients enrolled
Trial Details
Trial ID
NCT03257436
Start Date
January 5 2018
End Date
November 19 2020
Last Update
January 3 2022
Active Locations (54)
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1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36604
2
Phoenix Cardiovascular Group
Phoenix, Arizona, United States, 85006
3
Cardiology Associates of NEA
Jonesboro, Arkansas, United States, 72401
4
Foothill Cardiology Medical Group
Arcadia, California, United States, 91007