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NCT02661451 · ClinicalTrials.gov registry record · NA

Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

A NA study of Aortic Valve Stenosis, sponsored by Cardiovascular Research Foundation, New York.

Active
Registry status
NA
Development phase
178
Enrollment target
20
Study locations

NCT02661451: Active NA study of Aortic Valve Stenosis, sponsored by Cardiovascular Research Foundation, New York.

NCT02661451 is a NA study of Aortic Valve Stenosis that is active but no longer recruiting, run by Cardiovascular Research Foundation, New York. The registered enrollment target is 178 participants, below the 1,037-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02661451, a NA study of Aortic Valve Stenosis, is active but no longer recruiting, sponsored by Cardiovascular Research Foundation, New York.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
178 participants
Enrollment target
20
Study locations

Study Summary

The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

Primary Outcome

Hierarchical occurrence within efficacy assessment time interval (EATI) of:

Conditions Studied

Interventions

  • DEVICE SAPIEN 3 THV
  • BIOLOGICAL Optimal Heart Failure Therapy

Study Locations (20)

Illinois

  • Advocate Christ Hospital - Chicago
  • Northwestern University - Chicago
  • Alexian Brothers Medical Center - Elk Grove Village
  • Evanston Hospital/NorthShore Univ. Health System - Evanston
  • Advocate Lutheran General Hospital - Park Ridge
  • Carle Foundation Hospital - Urbana

California

  • UCSD/Sulpizio Cardiovascular Center - La Jolla
  • University of Southern California - Los Angeles - Los Angeles
  • UCLA Medical Center - Los Angeles
  • St. Joseph Hospital - Orange
  • UCSF - San Francisco

Florida

  • University of Miami - Miami
  • Cleveland Clinic Florida - Weston

Massachusetts

  • Tufts Medical Center - Boston
  • Massachusetts General Hospital - Boston

Arizona

  • Chandler Regional Medical Center - Chandler

Colorado

  • Medical Center of the Rockies - Loveland

Connecticut

  • Yale University - New Haven

District of Columbia

  • Medstar Washington Hospital Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2016-09
Est. Completion 2025-02
Phase NA

What the registry record for NCT02661451 still lists

NCT02661451 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 1,037-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (83% lower).

The record links to 1 condition, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions - of which SAPIEN 3 THV is the first listed.

NCT02661451 names 20 study sites across 9 states, led by Illinois, California, Florida.

Frequently Asked Questions

What is clinical trial NCT02661451 about?

NCT02661451 is a clinical study titled "Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)". The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

What is the current status of trial NCT02661451?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 178 participants. The study started on 2016-09. Estimated completion is 2025-02.

What conditions does trial NCT02661451 study?

This clinical trial studies the following conditions: Aortic Valve Stenosis.

What interventions are being tested in trial NCT02661451?

The interventions under investigation include: SAPIEN 3 THV (DEVICE), Optimal Heart Failure Therapy (BIOLOGICAL).

Who is sponsoring clinical trial NCT02661451?

This trial is sponsored by Cardiovascular Research Foundation, New York, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02661451 being conducted?

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

Similar trials for Aortic Valve Stenosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02661451's enrollment target sits among peer trials

178 17th of 30 higher than 14 of 30 other Aortic Valve Stenosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Aortic Valve Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02661451, the US trial registry maintained by the National Library of Medicine. NCT02661451 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.