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Flow Regulation by Opening the Septum in Patients With Heart Failure Trial

NCT03751748 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2018-11-23

No results posted yet for this study

Summary

To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction.

Conditions

  • Heart Failure With Normal Ejection Fraction

Interventions

DEVICE

AFR implantation

Implantation of atrial flow regulator (AFR) device

DEVICE

Sham procedure

Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo

Sponsors & Collaborators

  • Sinai Health System

    collaborator OTHER

  • University Health Network, Toronto

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-12-31
Completion
2021-04-30

Countries

  • Canada

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 NCT03751748 on ClinicalTrials.gov