Clinical trial NCT02071173: Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
Official title: Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads: NAVIGATE X4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Resynchronization Therapy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 2244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Every subject had access to two study devices and were followed as a single group.
Primary purpose: TREATMENT

Brief summary: The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market submission. Additionally, data from this study will be used to support post-market approval requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.


Eligibility criteria: Inclusion Criteria:

Subjects indicated for a CRT-D that fulfill one of the following 5 criteria\[1\]:

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:

Subjects who meet any one of the following criteria will be excluded from this clinical study.

* 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.

Primary outcomes:
measure: Percentage of ACUITY X4 Spiral Leads Free From Complication Through 6 Months
timeFrame: Implant through 6 months
measure: Percentage of ACUITY X4 Straight Leads Free From Complication Through 6 Months
timeFrame: Implant through 6 months
measure: Percentage of ACUITY X4 Leads With Acceptable Pacing Capture Thresholds (PCT)
timeFrame: Implant through 3 months
measure: Percentage of ACUITY X4 Spiral Leads With Acceptable Pacing Capture Thresholds (PCT) Using the Best Proximal Electrode
timeFrame: 3 months
measure: Percentage of RELIANCE 4-FRONT Leads Free From Complication Through 3 Months
timeFrame: Implant through 3 months
measure: Percentage of RELIANCE 4-FRONT Leads Free From Complication From 3 Through 24 Months
timeFrame: 3 months through 24 months
measure: Mean Pacing Capture Threshold (PCT) of RELIANCE 4-FRONT Leads at 3 Months
timeFrame: Implant through 3 months
Secondary outcomes:
measure: Mean Sensed Amplitude of ACUITY X4 Spiral Leads at 3 Months
timeFrame: 3 months
measure: Mean Sensed Amplitude of ACUITY X4 Straight Leads at 3 Months
timeFrame: 3 months
measure: Mean Pacing Impedance of ACUITY X4 Spiral Leads at 3 Months
timeFrame: 3 months
measure: Mean Pacing Impedance ACUITY X4 Straight Leads at 3 Months
timeFrame: 3 months
measure: Mean Detection Time of Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads
timeFrame: Within 30 days of implant
measure: Mean Sensed Amplitude of RELIANCE 4-FRONT Leads at 3 Months
timeFrame: 3 months
measure: Mean Pacing Impedance of RELIANCE 4-FRONT Active Fixation Leads at 3 Months
timeFrame: 3 months
measure: Mean Pacing Impedance of RELIANCE 4-FRONT Passive Fixation Leads at 3 Months
timeFrame: 3 months
measure: Percentage of Successfully Converted Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads
timeFrame: Within 30 days of implant
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Mesa
country: United States
facility: Banner Baywood Heart Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare - Osborn
state: Arizona
city: Jonesboro
country: United States
facility: Cardiology Associates of Northeast Arkansas, P.A.
state: Arkansas
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: USC Medical Center
state: California
city: Oakland
country: United States
facility: Alta Bates Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Delray Medical Center
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Largo
country: United States
facility: West Florida Cardiology Network, LLC
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Hospital System Inc.
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Dyer
country: United States
facility: Porter Memorial Hospital
state: Indiana
city: Fort Wayne
country: United States
facility: Lutheran Medical Group
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: Muncie
country: United States
facility: Ball Memorial Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic Regional Heart Center
state: Minnesota
city: Saint Cloud
country: United States
facility: St. Cloud Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Columbia
country: United States
facility: Boone Hospital Center
state: Missouri
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Haddon Heights
country: United States
facility: Cooper Hospital - University Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Williamsville
country: United States
facility: Buffalo General Hospital
state: New York
city: Williamsville
country: United States
facility: Mercy Hospital of Buffalo, Catholic Health System
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
state: Ohio
city: Steubenville
country: United States
facility: Wheeling Hospital Inc.
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Medford
country: United States
facility: Asante Rogue Regional Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Florence
country: United States
facility: PeeDee Cardiology Associates PA
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Heart Hospital of South Dakota
state: South Dakota
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation, Inc.
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Research Institute, LLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Beaumont
country: United States
facility: SouthEast Texas Clinical Research Center
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Dallas
country: United States
facility: Walnut Hill Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center of Fort Worth
state: Texas
city: The Woodlands
country: United States
facility: University of Texas Houston Health Science Center
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances Health System
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Mechanicsville
country: United States
facility: Bon Secours Heart & Vascular Institute
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialist
state: Virginia
city: Bellingham
country: United States
facility: PeaceHealth St. Joseph Medical Center
state: Washington
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Spokane
country: United States
facility: Kootenai Heart Clinics
state: Washington
city: Spokane
country: United States
facility: Providence Health & Services - Washington
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Morgantown
country: United States
facility: Monongalia General Hospital
state: West Virginia
Study officials:
affiliation: The Valley Hospital
name: Suneet Mittal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Martin Burke, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.