Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads

NCT02071173 | Completed Results

• 1 other identifier: C1481
• Study Type: interventional
• Target: 2,244
• Locations: 1 country
• Sites: 96

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.

Conditions

Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (7)

• Percentage of ACUITY X4 Spiral Leads Free From Complication Through 6 Months

  Lead-related complication-free rate of ACUITY X4 Spiral Leads from implant through 6 months post implant.

  Implant through 6 months

• Percentage of ACUITY X4 Straight Leads Free From Complication Through 6 Months

  Lead-related complication-free rate of ACUITY X4 Straight Leads from implant through 6 months post implant.

  Implant through 6 months

• Percentage of ACUITY X4 Leads With Acceptable Pacing Capture Thresholds (PCT)

  PCT measurements in the programmed configuration were collected at 3 months post-implant. Programmed configuration refers to the pacing configuration that was selected by the physician to provide LV pacing therapy. The percentage of measurements with PCT ≤ 2.5 V were calculated.

  Implant through 3 months

• Percentage of ACUITY X4 Spiral Leads With Acceptable Pacing Capture Thresholds (PCT) Using the Best Proximal Electrode

  PCT measurements in the in the proximal zone (electrodes 2, 3, 4) were collected at 3 months post-implant. Physician investigators were instructed to use the best proximal electrode (E2, E3 or E4) as the cathode and the RV lead coil or pulse generator as the anode; best was defined as the electrode with the lowest PCT without phrenic nerve stimulation. The percentage of measurements with PCT ≤ 2.5 V were calculated.

  3 months

• Percentage of RELIANCE 4-FRONT Leads Free From Complication Through 3 Months

  Lead-related complication-free rate of RELIANCE 4-FRONT Leads from implant through 3 months post implant.

  Implant through 3 months

• Percentage of RELIANCE 4-FRONT Leads Free From Complication From 3 Through 24 Months

  Lead-related complication-free rate of RELIANCE 4-FRONT Leads from 3 through 24 months post implant.

  3 months through 24 months

• Mean Pacing Capture Threshold (PCT) of RELIANCE 4-FRONT Leads at 3 Months

  PCT measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant. Measurements were performed using 0.5 millisecond pulse width.

  Implant through 3 months

Secondary Outcomes (9)

• Mean Sensed Amplitude of ACUITY X4 Spiral Leads at 3 Months

  3 months

• Mean Sensed Amplitude of ACUITY X4 Straight Leads at 3 Months

  3 months

• Mean Pacing Impedance of ACUITY X4 Spiral Leads at 3 Months

  3 months

• Mean Pacing Impedance ACUITY X4 Straight Leads at 3 Months

  3 months

• Mean Detection Time of Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads

  Within 30 days of implant

Study Arms (1)

Enrolled Patients

EXPERIMENTAL

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

Device: ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead

Interventions

ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead DEVICE

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.

Also known as: LV Quadripolar coronary venous lead, RV defibrillation Lead

Enrolled Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects indicated for a CRT-D that fulfill one of the following 5 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)\*
• 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\*
• 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\*
• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (96)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Huntsville Hospital

Huntsville, Alabama, 35801, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Banner Baywood Heart Hospital

Mesa, Arizona, 85206, United States

Location

Scottsdale Healthcare - Osborn

Scottsdale, Arizona, 85258, United States

Location

Cardiology Associates of Northeast Arkansas, P.A.

Jonesboro, Arkansas, 72401, United States

Location

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

USC Medical Center

Los Angeles, California, 90033, United States

Location

Alta Bates Medical Center

Oakland, California, 94609, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Delray Medical Center

Fort Lauderdale, Florida, 33334, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 38805, United States

Location

West Florida Cardiology Network, LLC

Largo, Florida, 33770, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Gwinnett Hospital System Inc.

Lawrenceville, Georgia, 30046, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

St. John's Hospital

Springfield, Illinois, 62769, United States

Location

Porter Memorial Hospital

Dyer, Indiana, 46311, United States

Location

Lutheran Medical Group

Fort Wayne, Indiana, 48804, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, 46260, United States

Location

Ball Memorial Hospital

Muncie, Indiana, 47303, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21237, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota, 55805, United States

Location

St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

United Heart and Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Location

Boone Hospital Center

Columbia, Missouri, 65201, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Cox Health

Springfield, Missouri, 65807, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Cooper Hospital - University Medical Center

Haddon Heights, New Jersey, 08035, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Buffalo General Hospital

Williamsville, New York, 14221, United States

Location

Mercy Hospital of Buffalo, Catholic Health System

Williamsville, New York, 14221, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Wheeling Hospital Inc.

Steubenville, Ohio, 43952, United States

Location

The Toledo Hospital

Toledo, Ohio, 43615, United States

Location

Asante Rogue Regional Medical Center

Medford, Oregon, 97504, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

PeeDee Cardiology Associates PA

Florence, South Carolina, 29506, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota, 57108, United States

Location

Stern Cardiovascular Foundation, Inc.

Germantown, Tennessee, 38138, United States

Location

St. Thomas Research Institute, LLC

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37215, United States

Location

Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

SouthEast Texas Clinical Research Center

Beaumont, Texas, 77702, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Walnut Hill Medical Center

Dallas, Texas, 75231, United States

Location

Plaza Medical Center of Fort Worth

Fort Worth, Texas, 76104, United States

Location

University of Texas Houston Health Science Center

The Woodlands, Texas, 77384, United States

Location

Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Bon Secours Heart & Vascular Institute

Mechanicsville, Virginia, 23116, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Cardiovascular Specialist

Richmond, Virginia, 23225, United States

Location

PeaceHealth St. Joseph Medical Center

Bellingham, Washington, 98225, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

Location

Kootenai Heart Clinics

Spokane, Washington, 99204, United States

Location

Providence Health & Services - Washington

Spokane, Washington, 99204, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Monongalia General Hospital

Morgantown, West Virginia, 26505, United States

Location

Related Publications (1)

• 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.

  PMID: 27434039 DERIVED

Limitations and Caveats

Data as of 5-Feb-2020. Follow-up is ongoing.

Results Point of Contact

• Title: Kelly Aspinwall
• Organization: Boston Scientific

kelly.aspinwall@bsci.com

1-800-CARDIAC

Study Officials

• Suneet Mittal, MD

  The Valley Hospital

  PRINCIPAL INVESTIGATOR

• Martin Burke, DO

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Every subject had access to two study devices and were followed as a single group.

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: April 14, 2014
• Primary Completion: April 19, 2017
• Study Completion: October 6, 2020
• Last Updated: January 7, 2021
• Results First Posted: October 30, 2020

Record last verified: 2020-12

Locations

US (96)