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Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study
NCT05136820 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-03-09 |
| Est. Completion | 2029-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05136820
The ClinicalTrials.gov registry entry for NCT05136820 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Occlutech International AB, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Heart Failure With Reduced Ejection Fraction (HFrEF) appearing as the primary indexed condition, and to 2 interventions — of which Sham Comparator is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05136820 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Arizona, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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 Reduced Ejection Fraction (HFrEF), Heart Failure With Preserved Ejection Fraction (HFpEF). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05136820?
The interventions under investigation include: Sham Comparator (DEVICE), Atrial Flow Regulator (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05136820?
This trial is sponsored by Occlutech International AB, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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