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NCT01314313 · ClinicalTrials.gov registry record · NA

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

A NA study, sponsored by Edwards Lifesciences.

Completed
Registry status
NA
Development phase
2,032
Enrollment target

NCT01314313 is a NA study that has completed, run by Edwards Lifesciences. The registered enrollment target is 2,032 participants.

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The verdict

NCT01314313, a NA study, has completed, sponsored by Edwards Lifesciences.

COMPLETED
Registry status
NA
Development phase
2,032 participants
Enrollment target

Study Summary

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

Interventions

  • DEVICE TAVR Implantation with SAPIEN XT
  • DEVICE SAVR Implantation

Trial Details

FieldValue
Enrollment Target 2,032 participants
Start Date 2011-03
Est. Completion 2024-01-17
Phase NA

Sponsor

Edwards Lifesciences

57 total trials

What the Registry Record Tells You About NCT01314313

The ClinicalTrials.gov registry entry for NCT01314313 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,032 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 0 conditions, and to 2 interventions - of which TAVR Implantation with SAPIEN XT is the first listed.

NCT01314313 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01314313 about?

NCT01314313 is a clinical study titled "PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk". The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

What is the current status of trial NCT01314313?

This trial is currently completed. It is a NA study. The enrollment target is 2,032 participants. The study started on 2011-03. Estimated completion is 2024-01-17.

What interventions are being tested in trial NCT01314313?

The interventions under investigation include: TAVR Implantation with SAPIEN XT (DEVICE), SAVR Implantation (DEVICE).

Who is sponsoring clinical trial NCT01314313?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.