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ACTIVE NOT RECRUITING NA

PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

NCT02675114 · View on ClinicalTrials.gov ↗

Study Summary

To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.

Conditions Studied

Interventions

  • DEVICE SAPIEN 3 THV
  • PROCEDURE SAVR

Study Locations (20)

California

  • Mills/Peninsula Health Services — Burlingame
  • Cedars-Sinai Medical Center — Los Angeles
  • University of California, Los Angeles/Ronald Reagan Medical Center — Los Angeles
  • Hoag Hospital — Newport Beach
  • Stanford Hospital and Clinics — Palo Alto
  • Sutter Health Sacramento — Sacramento
  • Kaiser Permanente San Francisco — San Francisco

Florida

  • JFK Medical Center / Atlantic Clinical Research Collaborative — Atlantis
  • University of Florida, Gainesville — Gainesville
  • Mount Sinai Medical Center — Miami Beach
  • Florida Hospital — Orlando

Illinois

  • Northwestern University — Chicago
  • Rush University Medical Center — Chicago
  • NorthShore University HealthSystem Research Institute — Evanston

Alabama

  • University of Alabama — Birmingham

Arizona

  • Banner University Medical Center — Phoenix

Colorado

  • UC Health Northern Colorado/Medical Center of the Rockies — Loveland

Connecticut

  • Hartford — Hartford

Georgia

  • Emory University — Atlanta

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2016-03
Est. Completion 2029-12
Phase NA

Sponsor

Edwards Lifesciences

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02675114

The ClinicalTrials.gov registry entry for NCT02675114 describes a study currently listed as active not recruiting. 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 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 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 Aortic Stenosis appearing as the primary indexed condition, and to 2 interventions — of which SAPIEN 3 THV 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: NCT02675114 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Illinois. 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 NCT02675114 about?

NCT02675114 is a clinical study titled "PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis". To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.

What is the current status of trial NCT02675114?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2016-03. Estimated completion is 2029-12.

What conditions does trial NCT02675114 study?

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

What interventions are being tested in trial NCT02675114?

The interventions under investigation include: SAPIEN 3 THV (DEVICE), SAVR (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02675114?

This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02675114 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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