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COMPLETED NA

Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis

NCT02628899 · View on ClinicalTrials.gov ↗

Study Summary

To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).

Conditions Studied

Interventions

  • DEVICE SAVR
  • DEVICE Transfemoral TAVR

Study Locations (11)

California

  • Sutter Health System — Sacramento
  • Foundation for Cardiovascular Medicine — San Diego

Virginia

  • Henrico Doctors' Hospital — Richmond
  • VCU Medical Center — Richmond

District of Columbia

  • MedStar Washington Hospital Center — Washington D.C.

Georgia

  • WellStar Kennestone Hospital — Marietta

Maine

  • Maine Medical Center — Portland

New Jersey

  • The Valley Hospital — Ridgewood

New York

  • Stony Brook Hospital — Stony Brook

Oklahoma

  • St. John Health System — Tulsa

Trial Details

FieldValue
Enrollment Target 277 participants
Start Date 2016-01
Est. Completion 2023-01
Phase NA

Sponsor

Medstar Health Research Institute

130 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02628899

The ClinicalTrials.gov registry entry for NCT02628899 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 277 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 130 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 SAVR 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: NCT02628899 reports 11 study locations spanning 9 distinct geographic areas — top geographies include California, Virginia, District of Columbia. 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 NCT02628899 about?

NCT02628899 is a clinical study titled "Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis". To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).

What is the current status of trial NCT02628899?

This trial is currently completed. It is a NA study. The enrollment target is 277 participants. The study started on 2016-01. Estimated completion is 2023-01.

What conditions does trial NCT02628899 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 NCT02628899?

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

Who is sponsoring clinical trial NCT02628899?

This trial is sponsored by Medstar Health Research Institute, which has 130 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02628899 being conducted?

This trial has 11 study locations across California, District of Columbia, Georgia, Maine, New Jersey. 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