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NCT07532369 · ClinicalTrials.gov registry record
Occlutech AFR Fontan Study
A clinical trial, sponsored by Occlutech International AB.
- Not yet
- Registry status
- 25
- Enrollment target
NCT07532369 is a clinical trial that has not yet begun recruiting, run by Occlutech International AB. The registered enrollment target is 25 participants.
The verdict
NCT07532369 has not yet begun recruiting, sponsored by Occlutech International AB.
- NOT YET RECRUITING
- Registry status
- 25 participants
- Enrollment target
Study Summary
The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation. This study will consist of a case series of congenital patients with Fontan failure who have been treated with an Occlutech AFR under the FDA's Expanded Access process. The scope of this study is to gain clinical experience on the Occlutech AFR in Fontan failure patients. Cases in this study will be evaluated to evaluate the safety and effectiveness of the device. The objective of this study is to evaluate the Occlutech AFR with respect to device safety and shunt patency at 1 year. Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.
Interventions
- DEVICE Occlutech Atrial Flow Regulator Retrospective Data Collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-05-01 |
| Est. Completion | 2026-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07532369
The ClinicalTrials.gov registry entry for NCT07532369 describes a study currently listed as not yet recruiting, categorized as an unspecified phase. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Occlutech International AB, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Occlutech Atrial Flow Regulator Retrospective Data Collection is the first listed.
NCT07532369 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07532369 about?
NCT07532369 is a clinical study titled "Occlutech AFR Fontan Study". The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation. This study will consist of a case series of congenital patients with Fontan failure who have been treated with an Oc...
What is the current status of trial NCT07532369?
This trial is currently not yet recruiting. The enrollment target is 25 participants. The study started on 2026-05-01. Estimated completion is 2026-09.
What interventions are being tested in trial NCT07532369?
The interventions under investigation include: Occlutech Atrial Flow Regulator Retrospective Data Collection (DEVICE).
Who is sponsoring clinical trial NCT07532369?
This trial is sponsored by Occlutech International AB, which has 3 total clinical trials registered on ClinicalTrials.gov.
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