N/A
N=584
Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
Left Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03257436 ↗Enrolled (actual)
584
Serious AEs
22.4%
Results posted
Jan 2022
Primary outcome: Primary: LV MSP Feature Related Complication-Free Rate — 99 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CRT-D (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LV MSP Feature Related Complication-Free Rate |
99 | — |
| PRIMARY Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months |
51.3 | — |
Summary
Prospective, multi-center, single arm, post approval study to be conducted in the United States.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03257436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.