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Cardiac Resynchronization TherapyNAVIGATE X4NCT02071173

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

A study testing ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead in people with Cardiac Resynchronization Therapy, run by Boston Scientific Corporation at 96 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Resynchronization Therapy
What is being tested?
ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,244 participants
Where
96 sitesUnited States
Study dates
14 Apr 2014to 6 Oct 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

96 sites in 1 country.

96 sites in 1 country

United States96 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Emory University Hospital

    Atlanta, Georgia, 30308

  • Texas Cardiac Arrhythmia Research

    Austin, Texas, 78705

  • Heart Hospital of Austin

    Austin, Texas, 78756

  • Union Memorial Hospital

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • SouthEast Texas Clinical Research Center

    Beaumont, Texas, 77702

  • PeaceHealth St. Joseph Medical Center

    Bellingham, Washington, 98225

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Aultman Hospital

    Canton, Ohio, 44710

  • University of North Carolina Hospital

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • University of Chicago

    Chicago, Illinois, 60637

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Boone Hospital Center

    Columbia, Missouri, 65201

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Walnut Hill Medical Center

    Dallas, Texas, 75231

  • St. Mary's Duluth Clinic Regional Heart Center

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Porter Memorial Hospital

    Dyer, Indiana, 46311

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • PeeDee Cardiology Associates PA

    Florence, South Carolina, 29506

  • Delray Medical Center

    Fort Lauderdale, Florida, 33334

  • Lutheran Medical Group

    Fort Wayne, Indiana, 48804

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas, 76104

  • Stern Cardiovascular Foundation, Inc.

    Germantown, Tennessee, 38138

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

  • Cooper Hospital - University Medical Center

    Haddon Heights, New Jersey, 08035

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Huntsville Hospital

    Huntsville, Alabama, 35801

  • St. Vincent's Hospital

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Cardiology Associates of Northeast Arkansas, P.A.

    Jonesboro, Arkansas, 72401

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Lakeland Regional Medical Center

    Lakeland, Florida, 38805

  • West Florida Cardiology Network, LLC

    Largo, Florida, 33770

  • Gwinnett Hospital System Inc.

    Lawrenceville, Georgia, 30046

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Kaiser Permanente

    Los Angeles, California, 90027

  • USC Medical Center

    Los Angeles, California, 90033

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • Bon Secours Heart & Vascular Institute

    Mechanicsville, Virginia, 23116

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504

  • Banner Baywood Heart Hospital

    Mesa, Arizona, 85206

  • Monongalia General Hospital

    Morgantown, West Virginia, 26505

  • Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Intermountain Medical Center

    Murray, Utah, 84107

  • St. Thomas Research Institute, LLC

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37215

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Columbia University Medical Center

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Alta Bates Medical Center

    Oakland, California, 94609

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Virginia Cardiovascular Specialist

    Richmond, Virginia, 23225

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mercy General Hospital

    Sacramento, California, 95819

  • St. Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • United Heart and Vascular Clinic

    Saint Paul, Minnesota, 55102

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Scottsdale Healthcare - Osborn

    Scottsdale, Arizona, 85258

  • Avera Heart Hospital of South Dakota

    Sioux Falls, South Dakota, 57108

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Kootenai Heart Clinics

    Spokane, Washington, 99204

  • Providence Health & Services - Washington

    Spokane, Washington, 99204

  • St. John's Hospital

    Springfield, Illinois, 62769

  • Cox Health

    Springfield, Missouri, 65807

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Wheeling Hospital Inc.

    Steubenville, Ohio, 43952

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • University of Texas Houston Health Science Center

    The Woodlands, Texas, 77384

  • The Toledo Hospital

    Toledo, Ohio, 43615

  • Trinity Mother Frances Health System

    Tyler, Texas, 75701

  • Buffalo General Hospital

    Williamsville, New York, 14221

  • Mercy Hospital of Buffalo, Catholic Health System

    Williamsville, New York, 14221

  • York Hospital

    York, Pennsylvania, 17403

  • St. Joseph Mercy Hospital

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called LV Quadripolar coronary venous lead, RV 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.

Study groups in NCT02071173
Study groupRoleWhat they receive
Enrolled PatientsExperimentalSubjects 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
Receives: Device: ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Implant through 6 months

  2. 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.

    Measured: Implant through 6 months

  3. 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.

    Measured: Implant through 3 months

  4. 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.

    Measured: 3 months

  5. 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.

    Measured: Implant through 3 months

  6. 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.

    Measured: 3 months through 24 months

  7. 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.

    Measured: Implant through 3 months

Secondary outcomes (9)

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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.

    Measured: Within 30 days of implant

  6. 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.

    Measured: 3 months

  7. 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.

    Measured: 3 months

  8. 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.

    Measured: 3 months

  9. 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

    Measured: Within 30 days of implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2014 (estimated)
  2. Study start14 Apr 2014
  3. Primary completion19 Apr 2017
  4. Study completion6 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Every subject had access to two study devices and were followed as a single group.
Masking
None (open label)
Enrolment
2,244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02071173
Sponsor's protocol ID
C1481
Acronym
NAVIGATE X4
Status last verified
Dec 2020
First submitted
21 Feb 2014
Last updated
7 Jan 2021
Data monitoring committee
No

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.

    PubMed 27434039

Questions about this trial

What is this clinical trial studying?

A study testing ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead in people with Cardiac Resynchronization Therapy, run by Boston Scientific Corporation at 96 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of ACUITY X4 Spiral Leads Free From Complication Through 6 Months (time frame: Implant through 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02071173, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.

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