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ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

NCT05172960 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1234

Last updated 2026-05-19

No results posted yet for this study

Summary

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Conditions

  • Aortic Stenosis, Severe

Interventions

DEVICE

SAPIEN X4 THV

Implantation of the SAPIEN X4 valve

DEVICE

SAPIEN X4S

Implantation of the SAPIEN X4S valve

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Tamim M. Nazif, MD · Columbia University

  • Rahul P. Sharma, MBBS · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-20
Primary Completion
2025-07-22
Completion
2037-01-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05172960 on ClinicalTrials.gov