Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING NA

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

NCT01586910 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Conditions Studied

Interventions

  • DEVICE Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
  • PROCEDURE Surgical Aortic Valve Replacement (SAVR)
  • DEVICE Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

Study Locations (20)

California

  • Cedars-Sinai Medical Center — Hollywood
  • Scripps Green Hospital — La Jolla
  • Keck Medical Center of USC — Los Angeles
  • El Camino Hospital — Mountain View
  • VA Palo Alto Health Care System — Palo Alto
  • Southern California Permenente Medical Group — Pasadena
  • Stanford University Medical Center — Stanford

Florida

  • Morton Plant Hospital — Clearwater
  • University of Miami — Coral Gables
  • Delray Medical Center — Delray Beach

Connecticut

  • Hartford Hospital — Hartford
  • Yale New Haven Hospital — New Haven

Georgia

  • Emory University — Atlanta
  • Piedmont Healthcare, Inc. — Atlanta

Arizona

  • Banner Good Samaritan Medical Center — Phoenix

District of Columbia

  • Washington Hospital Center — Washington D.C.

Hawaii

  • The Queen's Medical Center — Honolulu

Illinois

  • Loyola University of Chicago — Maywood

Trial Details

FieldValue
Enrollment Target 1,746 participants
Start Date 2012-04
Est. Completion 2026-11
Phase NA

Sponsor

Medtronic Cardiovascular

49 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01586910

The ClinicalTrials.gov registry entry for NCT01586910 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 1,746 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiovascular, which has 49 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 Severe Aortic Stenosis appearing as the primary indexed condition, and to 3 interventions — of which Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) 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: NCT01586910 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Connecticut. 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 NCT01586910 about?

NCT01586910 is a clinical study titled "Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).". The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Med...

What is the current status of trial NCT01586910?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,746 participants. The study started on 2012-04. Estimated completion is 2026-11.

What conditions does trial NCT01586910 study?

This clinical trial studies the following conditions: Severe 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 NCT01586910?

The interventions under investigation include: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) (DEVICE), Surgical Aortic Valve Replacement (SAVR) (PROCEDURE), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01586910?

This trial is sponsored by Medtronic Cardiovascular, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01586910 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. 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