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

Left Ventricular Dysfunction Clinical Trial

— SMARTMSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257436
• Other study ID #: 92050975
• Status: Completed
• Phase: N/A
• Start date: January 5, 2018
• Est. completion date: November 19, 2020

Study information

• Verified date: December 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, single arm, post approval study to be conducted in the United States.

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 information / eligibility

• Status: Completed
• Enrollment: 586
• Est. completion date: November 19, 2020
• Est. primary completion date: November 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• CRT-D
Left Ventricular MultiSite Pacing

Locations

Country	Name	City	State
United States	AnMed Health Clinical Research	Anderson	South Carolina
United States	Foothill Cardiology Medical Group	Arcadia	California
United States	Augusta University	Augusta	Georgia
United States	MedStar Heart and Vascular Institute	Baltimore	Maryland
United States	Heartplace, PA	Bedford	Texas
United States	Billings Clinic	Billings	Montana
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	University of Virginia	Charlottesville	Virginia
United States	Chula Vista Cardiac Center	Chula Vista	California
United States	Trihealth- Good Samaritan & Bethesda North Hospitals	Cincinnati	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Delray Medical Center	Delray Beach	Florida
United States	Ascension St. John Hospital & Medical Center	Detroit	Michigan
United States	Durham VA medical Center	Durham	North Carolina
United States	Alexian Brothers Hospital Network	Elk Grove Village	Illinois
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Parkview Hospital Inc	Fort Wayne	Indiana
United States	Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	Hackensack University Medical Canter	Hackensack	New Jersey
United States	UT Health	Houston	Texas
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	UMMC- Division of Cardiology	Jackson	Mississippi
United States	UF Health Jacksonville	Jacksonville	Florida
United States	Cardiology Associates of NEA	Jonesboro	Arkansas
United States	St. Lukes Hospital	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Florida Hospital Waterman	Lake Mary	Florida
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Norton Heart Specialist	Louisville	Kentucky
United States	Carient Heart and Vascular	Manassas	Virginia
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Sentara Norfolk General	Norfolk	Virginia
United States	Methodist Physicians Clinic Heart Consultants	Omaha	Nebraska
United States	Desert Heart Rhythm Consultants	Palm Springs	California
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Phoenix Cardiovascular Group	Phoenix	Arizona
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	WakeMed	Raleigh	North Carolina
United States	Rapid City Regional Health	Rapid City	South Dakota
United States	St. Mary's of Michigan Research Institute at Covenant Medical Ceter	Saginaw	Michigan
United States	Salem Health	Salem	Oregon
United States	University of Utah	Salt Lake City	Utah
United States	Advanced Cardiovascular Specialists	Shreveport	Louisiana
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Cardiology Associates Medical Group	Ventura	California
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania
United States	Berk Cardiologists	Wyomissing	Pennsylvania
United States	St. Elizabeth Youngstown Hospital	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV MSP Feature Related Complication-Free Rate	Proportion of subjects free from LVMSP feature related complications at 12 months	Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.
Primary	Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months	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.	12 Month Follow Up