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NCT05452720 · ClinicalTrials.gov registry record · NA
MASA Valve Early Feasibility Study
A NA study of Tetrology of Fallot and Transposition of Great Vessels, sponsored by PECA Labs.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 5
- Study locations
NCT05452720: Recruiting NA study of Tetrology of Fallot and Transposition of Great Vessels, sponsored by PECA Labs.
NCT05452720 is a NA study of Tetrology of Fallot and Transposition of Great Vessels that is actively recruiting participants, run by PECA Labs. The registered enrollment target is 10 participants, below the 89-participant average among 3 other Tetrology of Fallot trials with a reported enrollment target (89% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05452720, a NA study of Tetrology of Fallot and Transposition of Great Vessels, is actively recruiting participants, sponsored by PECA Labs.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 5
- Study locations
Study Summary
The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). As an early feasibility study, the purpose is determine the feasibility of success of the device in order to gather early data towards a future pivotal study and/or regulatory clearance submission.
Primary Outcome
Percentage of patients that have not died related to the device 1 year from implantation
Conditions Studied
Interventions
- DEVICE Surgical Right Ventricular Outflow Tract Reconstruction
Study Locations (5)
Illinois
- OSF Childrens Hospital of Illinois - Peoria
Massachusetts
- Boston Childrens Hospital - Boston
Ohio
- Cincinnati Children's Hospital - Cincinnati
Pennsylvania
- Childrens Hospital of Philadelphia - Philadelphia
Texas
- Childrens Medical Center Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-05-18 |
| Est. Completion | 2028-04-01 |
| Phase | NA |
What NCT05452720 shows while recruiting
NCT05452720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 89-participant average among 3 other Tetrology of Fallot trials with a reported enrollment target (89% lower).
The record links to 6 conditions, with Tetrology of Fallot appearing as the primary indexed condition, and to 1 intervention - of which Surgical Right Ventricular Outflow Tract Reconstruction is the first listed.
NCT05452720 lists 5 locations in 5 states (Illinois, Massachusetts, Ohio).
Frequently Asked Questions
What is clinical trial NCT05452720 about?
NCT05452720 is a clinical study titled "MASA Valve Early Feasibility Study". The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiri...
What is the current status of trial NCT05452720?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2023-05-18. Estimated completion is 2028-04-01.
What conditions does trial NCT05452720 study?
This clinical trial studies the following conditions: Tetrology of Fallot, Transposition of Great Vessels, Pulmonary Stenosis, Truncus Arteriosus, Pulmonary Atresia.
What interventions are being tested in trial NCT05452720?
The interventions under investigation include: Surgical Right Ventricular Outflow Tract Reconstruction (DEVICE).
Who is sponsoring clinical trial NCT05452720?
This trial is sponsored by PECA Labs, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05452720 being conducted?
This trial has 5 study locations across Illinois, Massachusetts, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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