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

Not Applicable

Completed

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 in accordance with its approved labeling.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Single Arm	CRT-D	General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.

Primary Outcome Measures

Name	Time	Method
LV MSP Feature Related Complication-Free Rate	Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.	Proportion of subjects free from LVMSP feature related complications at 12 months
Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months	12 Month Follow Up	Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.

Secondary Outcome Measures

Name	Time	Method

Locations (54): Mobile Infirmary Medical Center
🇺🇸
Mobile, Alabama, United States
Phoenix Cardiovascular Group
🇺🇸
Phoenix, Arizona, United States
Cardiology Associates of NEA
🇺🇸
Jonesboro, Arkansas, United States
Foothill Cardiology Medical Group
🇺🇸
Arcadia, California, United States
Chula Vista Cardiac Center
🇺🇸
Chula Vista, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸
Los Angeles, California, United States
Desert Heart Rhythm Consultants
🇺🇸
Palm Springs, California, United States
Cardiology Associates Medical Group
🇺🇸
Ventura, California, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
Delray Medical Center
🇺🇸
Delray Beach, Florida, United States
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Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States