ClinicalTrials.gov record
Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
ClinicalTrials.gov ID: NCT02071173
Public ClinicalTrials.gov record NCT02071173. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads: NAVIGATE X4
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02071173
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 2,244 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 14, 2014 (Actual)
- Primary completion
- Apr 19, 2017 (Actual)
- Completion
- Oct 6, 2020 (Actual)
- Last update posted
- Jan 7, 2021
2014 – 2020
United States locations
- U.S. sites
- 96
- U.S. states
- 34
- U.S. cities
- 88
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Huntsville Hospital | Huntsville | Alabama | 35801 | — |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | — |
| Banner Baywood Heart Hospital | Mesa | Arizona | 85206 | — |
| Scottsdale Healthcare - Osborn | Scottsdale | Arizona | 85258 | — |
| Cardiology Associates of Northeast Arkansas, P.A. | Jonesboro | Arkansas | 72401 | — |
| Kaiser Permanente | Los Angeles | California | 90027 | — |
| USC Medical Center | Los Angeles | California | 90033 | — |
| Alta Bates Medical Center | Oakland | California | 94609 | — |
| Mercy General Hospital | Sacramento | California | 95819 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Delray Medical Center | Fort Lauderdale | Florida | 33334 | — |
| Lakeland Regional Medical Center | Lakeland | Florida | 38805 | — |
| West Florida Cardiology Network, LLC | Largo | Florida | 33770 | — |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Emory University Hospital | Atlanta | Georgia | 30308 | — |
| Gwinnett Hospital System Inc. | Lawrenceville | Georgia | 30046 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Alexian Brothers Medical Center | Elk Grove Village | Illinois | 60007 | — |
| St. John's Hospital | Springfield | Illinois | 62769 | — |
| Porter Memorial Hospital | Dyer | Indiana | 46311 | — |
| Lutheran Medical Group | Fort Wayne | Indiana | 48804 | — |
| St. Vincent's Hospital | Indianapolis | Indiana | 46260 | — |
| Ball Memorial Hospital | Muncie | Indiana | 47303 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| Union Memorial Hospital | Baltimore | Maryland | 21237 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | — |
| St. Joseph Mercy Hospital | Ypsilanti | Michigan | 48197 | — |
| St. Mary's Duluth Clinic Regional Heart Center | Duluth | Minnesota | 55805 | — |
| 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 | — |
| Boone Hospital Center | Columbia | Missouri | 65201 | — |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Cox Health | Springfield | Missouri | 65807 | — |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Nebraska Heart Institute | Lincoln | Nebraska | 68526 | — |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | — |
| Cooper Hospital - University Medical Center | Haddon Heights | New Jersey | 08035 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Buffalo General Hospital | Williamsville | New York | 14221 | — |
| Mercy Hospital of Buffalo, Catholic Health System | Williamsville | New York | 14221 | — |
| University of North Carolina Hospital | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Aultman Hospital | Canton | Ohio | 44710 | — |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| OhioHealth Research and Innovation Institute - Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Wheeling Hospital Inc. | Steubenville | Ohio | 43952 | — |
| The Toledo Hospital | Toledo | Ohio | 43615 | — |
| Asante Rogue Regional Medical Center | Medford | Oregon | 97504 | — |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | — |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | — |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | — |
| York Hospital | York | Pennsylvania | 17403 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| PeeDee Cardiology Associates PA | Florence | South Carolina | 29506 | — |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | — |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | — |
| Avera Heart Hospital of South Dakota | Sioux Falls | South Dakota | 57108 | — |
| Stern Cardiovascular Foundation, Inc. | Germantown | Tennessee | 38138 | — |
| St. Thomas Research Institute, LLC | Nashville | Tennessee | 37205 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37215 | — |
| Texas Cardiac Arrhythmia Research | Austin | Texas | 78705 | — |
| Heart Hospital of Austin | Austin | Texas | 78756 | — |
| SouthEast Texas Clinical Research Center | Beaumont | Texas | 77702 | — |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| Walnut Hill Medical Center | Dallas | Texas | 75231 | — |
| Plaza Medical Center of Fort Worth | Fort Worth | Texas | 76104 | — |
| University of Texas Houston Health Science Center | The Woodlands | Texas | 77384 | — |
| Trinity Mother Frances Health System | Tyler | Texas | 75701 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| Bon Secours Heart & Vascular Institute | Mechanicsville | Virginia | 23116 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Virginia Cardiovascular Specialist | Richmond | Virginia | 23225 | — |
| PeaceHealth St. Joseph Medical Center | Bellingham | Washington | 98225 | — |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | — |
| Kootenai Heart Clinics | Spokane | Washington | 99204 | — |
| Providence Health & Services - Washington | Spokane | Washington | 99204 | — |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | — |
| Monongalia General Hospital | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02071173, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 7, 2021 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02071173 live on ClinicalTrials.gov.