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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Resynchronization Therapy
• Intervention / Treatment: Device: ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead

• Study Type: Interventional
• Enrollment (Actual): 2244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Huntsville, Alabama, United States, 35801
      • Huntsville Hospital
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Providence Alaska Medical Center
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Banner Baywood Heart Hospital
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Healthcare - Osborn
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Cardiology Associates of Northeast Arkansas, P.A.
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente
    • Los Angeles, California, United States, 90033
      • USC Medical Center
    • Oakland, California, United States, 94609
      • Alta Bates Medical Center
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
  • Florida
    • Fort Lauderdale, Florida, United States, 33334
      • Delray Medical Center
    • Lakeland, Florida, United States, 38805
      • Lakeland Regional Medical Center
    • Largo, Florida, United States, 33770
      • West Florida Cardiology Network, LLC
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
    • Lawrenceville, Georgia, United States, 30046
      • Gwinnett Hospital System Inc.
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
    • Springfield, Illinois, United States, 62769
      • St. John's Hospital
  • Indiana
    • Dyer, Indiana, United States, 46311
      • Porter Memorial Hospital
    • Fort Wayne, Indiana, United States, 48804
      • Lutheran Medical Group
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent's Hospital
    • Muncie, Indiana, United States, 47303
      • Ball Memorial Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Union Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Hospitals
    • Ypsilanti, Michigan, United States, 48197
      • St. Joseph Mercy Hospital
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • St. Mary's Duluth Clinic Regional Heart Center
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Hospital
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast St. Joseph's Hospital
    • Saint Paul, Minnesota, United States, 55102
      • United Heart and Vascular Clinic
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Boone Hospital Center
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital of Kansas City
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
    • Springfield, Missouri, United States, 65807
      • Cox Health
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
    • Haddon Heights, New Jersey, United States, 08035
      • Cooper Hospital - University Medical Center
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
    • Williamsville, New York, United States, 14221
      • Buffalo General Hospital
    • Williamsville, New York, United States, 14221
      • Mercy Hospital of Buffalo, Catholic Health System
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Hospital
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
    • Steubenville, Ohio, United States, 43952
      • Wheeling Hospital Inc.
    • Toledo, Ohio, United States, 43615
      • The Toledo Hospital
  • Oregon
    • Medford, Oregon, United States, 97504
      • Asante Rogue Regional Medical Center
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Allentown, Pennsylvania, United States, 18103
      • LeHigh Valley Hospital
    • York, Pennsylvania, United States, 17403
      • York Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Florence, South Carolina, United States, 29506
      • PeeDee Cardiology Associates PA
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Regional Hospital
    • Sioux Falls, South Dakota, United States, 57108
      • Avera Heart Hospital of South Dakota
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular Foundation, Inc.
    • Nashville, Tennessee, United States, 37205
      • St. Thomas Research Institute, LLC
    • Nashville, Tennessee, United States, 37215
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research
    • Beaumont, Texas, United States, 77702
      • Southeast Texas Clinical Research Center
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • Dallas, Texas, United States, 75231
      • Walnut Hill Medical Center
    • Fort Worth, Texas, United States, 76104
      • Plaza Medical Center of Fort Worth
    • The Woodlands, Texas, United States, 77384
      • University of Texas Houston Health Science Center
    • Tyler, Texas, United States, 75701
      • Trinity Mother Frances Health System
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Mechanicsville, Virginia, United States, 23116
      • Bon Secours Heart & Vascular Institute
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23225
      • Virginia Cardiovascular Specialist
  • Washington
    • Bellingham, Washington, United States, 98225
      • PeaceHealth St. Joseph Medical Center
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett
    • Spokane, Washington, United States, 99204
      • Providence Health & Services - Washington
    • Spokane, Washington, United States, 99204
      • Kootenai Heart Clinics
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center
    • Morgantown, West Virginia, United States, 26505
      • Monongalia General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: 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 Names: LV Quadripolar coronary venous lead; RV defibrillation Lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Sensed Amplitude of ACUITY X4 Spiral Leads at 3 Months	Sensed amplitude measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.	3 months
Mean Sensed Amplitude of ACUITY X4 Straight Leads at 3 Months	Sensed amplitude measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.	3 months
Mean Pacing Impedance of ACUITY X4 Spiral Leads at 3 Months	Pacing impedance measurements from ACUITY X4 Spiral leads were collected at 3 months post-implant.	3 months
Mean Pacing Impedance ACUITY X4 Straight Leads at 3 Months	Pacing impedance measurements from ACUITY X4 Straight leads were collected at 3 months post-implant.	3 months
Mean Detection Time of Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads	The mean detection time, in seconds, of induced VT/VF episodes occurring within 30 days of implant were evaluated. Subjects were required to implanted with RELIANCE 4-FRONT leads to be evaluated.	Within 30 days of implant
Mean Sensed Amplitude of RELIANCE 4-FRONT Leads at 3 Months	Sensed amplitude measurements from RELIANCE 4-FRONT leads were collected at 3 months post-implant.	3 months
Mean Pacing Impedance of RELIANCE 4-FRONT Active Fixation Leads at 3 Months	Pacing impedance measurements from RELIANCE 4-FRONT Active Fixation leads were collected at 3 months post-implant.	3 months
Mean Pacing Impedance of RELIANCE 4-FRONT Passive Fixation Leads at 3 Months	Pacing impedance measurements from RELIANCE 4-FRONT Passive Fixation leads were collected at 3 months post-implant.	3 months
Percentage of Successfully Converted Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episodes Using RELIANCE 4-FRONT Leads	Ventricular Tachyarrhythmia (VT/VF) Shock Conversion Efficacy, analyzed within 30 days of implant	Within 30 days of implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Martin Burke, DO, University of Chicago

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2014
• Primary Completion (Actual): April 19, 2017
• Study Completion (Actual): October 6, 2020

Study Registration Dates

• First Submitted: February 21, 2014
• First Submitted That Met QC Criteria: February 21, 2014
• First Posted (Estimate): February 25, 2014

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: C1481