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ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System

NCT05686317 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-13

No results posted yet for this study

Summary

This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.

Conditions

Interventions

DEVICE

Edwards APTURE transcatheter shunt system

Treatment with APTURE shunt

DIAGNOSTIC_TEST

Sham procedure

CS angiography

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2026-11-01
Completion
2030-08-31
FDA Device
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT05686317 on ClinicalTrials.gov