Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
NCT ID: NCT02071173
Last Updated: 2021-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2244 participants
INTERVENTIONAL
2014-04-14
2020-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enrolled Patients
Subjects undergo an implant procedure to receive at least one investigational lead -- ACUITY X4 left ventricular (LV) CRT lead, RELIANCE 4-FRONT right ventricular (RV) ICD lead
ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead
The ACUITY X4 leads are intended for chronic left ventricular pacing and sensing. The leads have 3 tip configuration designs (straight tip, short tip spiral, and long tip spiral), which is intended to provide choices for patients with different anatomies.
The RELIANCE 4-FRONT leads are designed for right-side heart applications within the ventricle, atrium, and superior vena cava. It is intended for permanent sensing, pacing, and defibrillation when used with a compatible implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
Subjects were allowed to receive both the ACUITY X4 and RELIANCE 4-FRONT lead.
Interventions
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ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead
The ACUITY X4 leads are intended for chronic left ventricular pacing and sensing. The leads have 3 tip configuration designs (straight tip, short tip spiral, and long tip spiral), which is intended to provide choices for patients with different anatomies.
The RELIANCE 4-FRONT leads are designed for right-side heart applications within the ventricle, atrium, and superior vena cava. It is intended for permanent sensing, pacing, and defibrillation when used with a compatible implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
Subjects were allowed to receive both the ACUITY X4 and RELIANCE 4-FRONT lead.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Subject with left ventricular ejection fraction (LVEF) less than or equal to 35%, sinus rhythm, left bundle branch block (LBBB) with a QRS duration greater than or equal to 150 ms, and a NYHA class II, III or ambulatory IV symptoms on Guideline-Directed Medical Therapy (GDMT)\*
2. Subject with LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT\*
3. Subject with LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with a QRS duration greater than or equal to 150 ms, and NYHA class III/ ambulatory class IV symptoms on GDMT\*
4. Subject with atrial fibrillation and LVEF less than or equal to 35% on GDMT\* if a) the subject requires ventricular pacing or otherwise meets CRT criteria \[listed here\] and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT
5. Subject on GDMT\* who have LVEF less than or equal to 35% and are undergoing new device placement with anticipated requirement for significant (\>40%) ventricular pacing \*GDMT = Guideline-directed medical therapy (formerly known as optimal pharmaceutical therapy (OPT)), represents optimal medical therapy as defined by ACCF/ AHA guideline-recommended therapies (primarily Class I)
* Subject is intended to receive the ACUITY X4 LV lead and RELIANCE 4-FRONT RV lead (optional in Study Phase 1) and BSC CRT-D with quadripolar header as their initial (de novo) cardiac implants
* Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative \[LAR\] for documentation of informed consent) and participating in all testing associated with this investigation at an approved center and at the intervals defined by this protocol
* Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion Criteria
* Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
* Subject has a mechanical tricuspid heart valve
* Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries\* that are not in conflict and do not affect the following:
* Schedule of procedures for the Study (i.e. should not cause additional or missed visits);
* Study outcome (i.e. involve medications that could affect the heart rate of the subject);
* Conduct of the Study per good clinical practice (GCP) / International Organization for Standardization (ISO) 14155:2011/ 21 Code of Federal Regulations (CFR) 812, local regulations
* Subject is currently on the active heart transplant list
* Subject has a documented life expectancy of less than twelve months
* Women of childbearing potential who are or might be pregnant at the time of study enrollment or CRT-D System implant (method of assessment upon physician's discretion)
* Subjects currently requiring chronic dialysis \*Sponsors of such studies/registries should be informed and Boston Scientific must be informed by the investigator about the parallel conduct of these projects in the subject and of the project's basic nature. The decision if a desired mandatory governmental registry or observational study/ registry is in conflict with this exclusion criterion is up to the enrolling investigator.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Suneet Mittal, MD
Role: PRINCIPAL_INVESTIGATOR
The Valley Hospital
Martin Burke, DO
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Huntsville Hospital
Huntsville, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Banner Baywood Heart Hospital
Mesa, Arizona, United States
Scottsdale Healthcare - Osborn
Scottsdale, Arizona, United States
Cardiology Associates of Northeast Arkansas, P.A.
Jonesboro, Arkansas, United States
Kaiser Permanente
Los Angeles, California, United States
USC Medical Center
Los Angeles, California, United States
Alta Bates Medical Center
Oakland, California, United States
Mercy General Hospital
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Delray Medical Center
Fort Lauderdale, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
West Florida Cardiology Network, LLC
Largo, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
Porter Memorial Hospital
Dyer, Indiana, United States
Lutheran Medical Group
Fort Wayne, Indiana, United States
St. Vincent's Hospital
Indianapolis, Indiana, United States
Ball Memorial Hospital
Muncie, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States
St. Cloud Hospital
Saint Cloud, Minnesota, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
Boone Hospital Center
Columbia, Missouri, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Cox Health
Springfield, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Cooper Hospital - University Medical Center
Haddon Heights, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
Maimonides Medical Center
Brooklyn, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Columbia University Medical Center
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Buffalo General Hospital
Williamsville, New York, United States
Mercy Hospital of Buffalo, Catholic Health System
Williamsville, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, United States
Wheeling Hospital Inc.
Steubenville, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Asante Rogue Regional Medical Center
Medford, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
PeeDee Cardiology Associates PA
Florence, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Avera Heart Hospital of South Dakota
Sioux Falls, South Dakota, United States
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, United States
St. Thomas Research Institute, LLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
Heart Hospital of Austin
Austin, Texas, United States
SouthEast Texas Clinical Research Center
Beaumont, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Walnut Hill Medical Center
Dallas, Texas, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, United States
University of Texas Houston Health Science Center
The Woodlands, Texas, United States
Trinity Mother Frances Health System
Tyler, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Bon Secours Heart & Vascular Institute
Mechanicsville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Cardiovascular Specialist
Richmond, Virginia, United States
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Kootenai Heart Clinics
Spokane, Washington, United States
Providence Health & Services - Washington
Spokane, Washington, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Monongalia General Hospital
Morgantown, West Virginia, United States
Countries
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References
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Mittal S, Nair D, Padanilam BJ, Ciuffo A, Gupta N, Gallagher P, Goldner B, Hammill EF, Wold N, Stein K, Burke M. Performance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial. J Cardiovasc Electrophysiol. 2016 Oct;27(10):1199-1205. doi: 10.1111/jce.13044. Epub 2016 Aug 19.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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C1481
Identifier Type: -
Identifier Source: org_study_id
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