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Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)

NCT04000607 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-01-27

No results posted yet for this study

Summary

The Exploratory study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.

Conditions

Interventions

DEVICE

APTURE transcatheter shunt

Transcatheter treatment of symptomatic left heart failure patients

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-10
Primary Completion
2023-11-03
Completion
2028-11-11
FDA Device
Yes

Countries

  • Canada

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 NCT04000607 on ClinicalTrials.gov