Clinical trial NCT03257436: Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
Official title: Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Dysfunction
Keywords: Pacing
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: LV MSP Feature Related Complication-Free Rate
timeFrame: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.
measure: Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months
timeFrame: 12 Month Follow Up
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Group
state: Arizona
city: Jonesboro
country: United States
facility: Cardiology Associates of NEA
state: Arkansas
city: Arcadia
country: United States
facility: Foothill Cardiology Medical Group
state: California
city: Chula Vista
country: United States
facility: Chula Vista Cardiac Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Palm Springs
country: United States
facility: Desert Heart Rhythm Consultants
state: California
city: Ventura
country: United States
facility: Cardiology Associates Medical Group
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Lake Mary
country: United States
facility: Florida Hospital Waterman
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Hospital Network
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Hospital Inc
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Heart Specialist
state: Kentucky
city: Shreveport
country: United States
facility: Advanced Cardiovascular Specialists
state: Louisiana
city: Baltimore
country: United States
facility: MedStar Heart and Vascular Institute
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Ascension St. John Hospital & Medical Center
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Saginaw
country: United States
facility: St. Mary's of Michigan Research Institute at Covenant Medical Ceter
state: Michigan
city: Jackson
country: United States
facility: UMMC- Division of Cardiology
state: Mississippi
city: Kansas City
country: United States
facility: St. Lukes Hospital
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Omaha
country: United States
facility: Methodist Physicians Clinic Heart Consultants
state: Nebraska
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Canter
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Durham VA medical Center
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Cincinnati
country: United States
facility: Trihealth- Good Samaritan & Bethesda North Hospitals
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Youngstown
country: United States
facility: St. Elizabeth Youngstown Hospital
state: Ohio
city: Salem
country: United States
facility: Salem Health
state: Oregon
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berk Cardiologists
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Clinical Research
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Health
state: South Dakota
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Bedford
country: United States
facility: Heartplace, PA
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Houston
country: United States
facility: UT Health
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Manassas
country: United States
facility: Carient Heart and Vascular
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General
state: Virginia
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Saba Samir
role: PRINCIPAL_INVESTIGATOR
References: