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NCT03222128 · ClinicalTrials.gov registry record · NA

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate

A NA study of Symptomatic Severe Aortic Stenosis, sponsored by Edwards Lifesciences.

Completed
Registry status
NA
Development phase
1,074
Enrollment target
20
Study locations

NCT03222128 is a NA study of Symptomatic Severe Aortic Stenosis that has completed, run by Edwards Lifesciences. The registered enrollment target is 1,074 participants. The trial reports 20 study locations across 12 states.

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The verdict

NCT03222128, a NA study of Symptomatic Severe Aortic Stenosis, has completed, sponsored by Edwards Lifesciences.

COMPLETED
Registry status
NA
Development phase
1,074 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.

Interventions

  • DEVICE TAVR

Study Locations (20)

California

  • Scripps Green Hospital - La Jolla
  • Cedars-Sinai Medical Center - Los Angeles
  • Mercy General Hospital - Sacramento
  • Stanford University Medical Center - Stanford

Illinois

  • Northwestern University - Chicago
  • Rush University Medical Center - Chicago
  • Northshore - Evanston
  • Prairie Education and Research Cooperative - Springfield

Florida

  • Morton Plant Hospital - Clearwater
  • University of Florida - Gainesville

Indiana

  • Indiana University Health-Methodist Hospital - Indianapolis
  • St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC - Indianapolis

Colorado

  • University of Colorado Hospital - Denver

District of Columbia

  • Washington Hospital Center - Washington D.C.

Georgia

  • Emory University - Atlanta

Iowa

  • The University of Iowa - Iowa City

Trial Details

FieldValue
Enrollment Target 1,074 participants
Start Date 2014-02-17
Est. Completion 2024-10-09
Phase NA

Sponsor

Edwards Lifesciences

57 total trials

What the Registry Record Tells You About NCT03222128

The ClinicalTrials.gov registry entry for NCT03222128 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,074 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Symptomatic Severe Aortic Stenosis appearing as the primary indexed condition, and to 1 intervention - of which TAVR is the first listed.

NCT03222128 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Illinois, Florida.

Frequently Asked Questions

What is clinical trial NCT03222128 about?

NCT03222128 is a clinical study titled "PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate". The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.

What is the current status of trial NCT03222128?

This trial is currently completed. It is a NA study. The enrollment target is 1,074 participants. The study started on 2014-02-17. Estimated completion is 2024-10-09.

What conditions does trial NCT03222128 study?

This clinical trial studies the following conditions: Symptomatic Severe Aortic Stenosis.

What interventions are being tested in trial NCT03222128?

The interventions under investigation include: TAVR (DEVICE).

Who is sponsoring clinical trial NCT03222128?

This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03222128 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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