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RECRUITING NA

MASA Valve Early Feasibility Study

NCT05452720 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 10 participants
Start Date 2023-05-18
Est. Completion 2028-04-01
Phase NA

Sponsor

PECA Labs

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05452720

The ClinicalTrials.gov registry entry for NCT05452720 describes a study currently listed as 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 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PECA Labs, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT05452720 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Illinois, Massachusetts, Ohio. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05452720?

The interventions under investigation include: Surgical Right Ventricular Outflow Tract Reconstruction (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05452720?

This trial is sponsored by PECA Labs, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial