RecruitingNot Applicable

MASA Valve Early Feasibility Study

United States10 participantsStarted 2023-05-18

Plain-language 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.

Who can participate

Age range

0 Years – 22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis.
. Age \< 22 years
. Patient is geographically stable and willing to return for 1 year follow-up for the trial.
. Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.
. The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Freedom from device related death

Timeframe: 1 year

Freedom from Explant

Timeframe: 1 year

Freedom from Device-Related Reoperation

Timeframe: 1 year

Freedom from Device-Related Catheter Intervention

Timeframe: 1 year

Freedom from Endocarditis

Timeframe: 1 year

Freedom from Thrombus

Timeframe: 1 year

Freedom from Major Hemorrhage

Timeframe: 1 year

Trial details

NCT IDNCT05452720

SponsorPECA Labs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-01

Contact for this trial

Arush Kalra, MBBS, MS

4123300746 arush@pecalabs.com

View on ClinicalTrials.gov More Tetrology of Fallot trials

Plain-language summary

Who can participate

Age range

0 Years – 22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis.
. Age \< 22 years
. Patient is geographically stable and willing to return for 1 year follow-up for the trial.
. Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.
. The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.

Exclusion criteria

What they're measuring

Freedom from device related death

Timeframe: 1 year

Freedom from Explant

Timeframe: 1 year

Freedom from Device-Related Reoperation

Timeframe: 1 year

Freedom from Device-Related Catheter Intervention

Timeframe: 1 year

Freedom from Endocarditis

Timeframe: 1 year

Freedom from Thrombus

Timeframe: 1 year

Freedom from Major Hemorrhage

Timeframe: 1 year