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COMPLETED NA

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

NCT02071173 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

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

Study Locations (20)

California

  • Kaiser Permanente — Los Angeles
  • USC Medical Center — Los Angeles
  • Alta Bates Medical Center — Oakland
  • Mercy General Hospital — Sacramento
  • Sharp Memorial Hospital — San Diego

Florida

  • Delray Medical Center — Fort Lauderdale
  • Lakeland Regional Medical Center — Lakeland
  • West Florida Cardiology Network, LLC — Largo
  • Tallahassee Memorial Hospital — Tallahassee
  • Tampa General Hospital — Tampa

Alabama

  • University of Alabama at Birmingham — Birmingham
  • Huntsville Hospital — Huntsville

Arizona

  • Banner Baywood Heart Hospital — Mesa
  • Scottsdale Healthcare - Osborn — Scottsdale

Connecticut

  • Hartford Hospital — Hartford
  • Yale University School of Medicine — New Haven

Georgia

  • Emory University Hospital — Atlanta
  • Gwinnett Hospital System Inc. — Lawrenceville

Alaska

  • Providence Alaska Medical Center — Anchorage

Arkansas

  • Cardiology Associates of Northeast Arkansas, P.A. — Jonesboro

Trial Details

FieldValue
Enrollment Target 2,244 participants
Start Date 2014-04-14
Est. Completion 2020-10-06
Phase NA

Sponsor

Boston Scientific Corporation

120 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02071173

The ClinicalTrials.gov registry entry for NCT02071173 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cardiac Resynchronization Therapy appearing as the primary indexed condition, and to 1 intervention — of which ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02071173 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02071173 about?

NCT02071173 is a clinical study titled "Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads". 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,...

What is the current status of trial NCT02071173?

This trial is currently completed. It is a NA study. The enrollment target is 2,244 participants. The study started on 2014-04-14. Estimated completion is 2020-10-06.

What conditions does trial NCT02071173 study?

This clinical trial studies the following conditions: Cardiac Resynchronization Therapy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02071173?

The interventions under investigation include: ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02071173?

This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02071173 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial