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NCT05136820 · ClinicalTrials.gov registry record · NA

Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study

A NA study of Heart Failure With Preserved Ejection Fraction (HFPEF) and Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by Occlutech International AB.

Active
Registry status
NA
Development phase
15
Enrollment target
2
Study locations

NCT05136820 is a NA study of Heart Failure With Preserved Ejection Fraction (HFPEF) and Heart Failure With Reduced Ejection Fraction (HFrEF) that is active but no longer recruiting, run by Occlutech International AB. The registered enrollment target is 15 participants, below the 218-participant average among 9 other Heart Failure With Preserved Ejection Fraction (HFPEF) trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT05136820, a NA study of Heart Failure With Preserved Ejection Fraction (HFPEF) and Heart Failure With Reduced Ejection Fraction (HFrEF), is active but no longer recruiting, sponsored by Occlutech International AB.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
15 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this clinical study is to assess the safety and effectiveness of the Atrial Flow Regulator in the treatment of subjects, 18 years of age or older, who have symptomatic heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) while on stable guideline directed medical therapy (GDMT) as outlined in the Guidelines for the Management of Heart Failure.

Conditions Studied

Heart Failure With Preserved Ejection Fraction (HFPEF) Heart Failure With Reduced Ejection Fraction (HFrEF)

Interventions

  • DEVICE Sham Comparator
  • DEVICE Atrial Flow Regulator

Study Locations (2)

Arizona

  • Arizona Heart Rhythm Center - Phoenix

New York

  • North Shore Northwell University Hospital Lenox Hill - New York

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2023-03-09
Est. Completion 2029-02
Phase NA

Sponsor

Occlutech International AB

3 total trials

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What the Registry Record Tells You About NCT05136820

The ClinicalTrials.gov registry entry for NCT05136820 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 9 other Heart Failure With Preserved Ejection Fraction (HFPEF) trials with a reported enrollment target (93% lower). The listed sponsor is Occlutech International AB, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heart Failure With Preserved Ejection Fraction (HFPEF) appearing as the primary indexed condition, and to 2 interventions - of which Sham Comparator is the first listed.

NCT05136820 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, New York.

Frequently Asked Questions

What is clinical trial NCT05136820 about?

NCT05136820 is a clinical study titled "Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study". The purpose of this clinical study is to assess the safety and effectiveness of the Atrial Flow Regulator in the treatment of subjects, 18 years of age or older, who have symptomatic heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) while ...

What is the current status of trial NCT05136820?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2023-03-09. Estimated completion is 2029-02.

What conditions does trial NCT05136820 study?

This clinical trial studies the following conditions: Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Reduced Ejection Fraction (HFrEF).

What interventions are being tested in trial NCT05136820?

The interventions under investigation include: Sham Comparator (DEVICE), Atrial Flow Regulator (DEVICE).

Who is sponsoring clinical trial NCT05136820?

This trial is sponsored by Occlutech International AB, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05136820 being conducted?

This trial has 2 study locations across Arizona, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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