Health TrialsbyHealthPanel

PULSTA TPV Observational Study

ConditionHeart Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10+
SponsorTaewoong Medical Co., Ltd.

About this trial

The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with moderate to severe pulmonary regurgitation and/or pulmonary stenosis who undergo transcatheter pulmonary valve implantation using the PULSTA Transcatheter Pulmonary Valve(TPV).

Patients who are willing to participate in the study and who have voluntarily provided written informed consent.

Disqualifiers

Patients who have not signed informed consent

Patients who are contraindicated for the implantation per the device's Instructions for Use.

Trial population

Patients with right ventricular outflow tract (RVOT) dysfunction who are considered eligible for percutaneous pulmonary valve implantation (PPVI) with the PULSTA TPV according to the approved indication and routine clinical practice at participating centers.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: PULSTA TPV Recipients

Trial outcomes

Primary outcomes

1

Procedural / device-related serious adverse events at 12 months

Time frame
12 months
2

Hemodynamic functional improvement at 12 months

Hemodynamic functional improvement is defined as the achievement of both of the following criteria: * Mild or less pulmonary regurgitation measured by echocardiography AND * Mean Right Ventricular Outflow Tract(RVOT) pressure gradient measured by echocardiography ≤35mmHg

Time frame
12 months

Secondary outcomes

1

Procedural success

Procedural success is defined as the Transcatheter Pulmonary Valve(TPV) implant in on the desired site, Right ventricle-Pulmonary artery (RV-PA) peak systolic pressure gradient \<35mmHg by cardiac catheterization, less mild pulmonary regurgitation by angiography, and freedom from explantation of the TPV at 24 hours following implantation.

Time frame
24 hours
2

Hemodynamic function at all follow-up visits

Hemodynamic function will be assessed including: * Peak RVOT pressure gradient (by echocardiography) * Mean RVOT pressure gradient (by echocardiography)

Time frame
5 years
3

Severity of pulmonary regurgitation (by echocardiography)

Severity of pulmonary regurgitation will be measured by Doppler echocardiography and classified into none, trace/trivial, mild, moderate, and severe.

Time frame
5 years
4

NYHA functional classification

Clinical outcome will be assessed as per the New York Heart Association (NYHA) functional classification at all follow-up visits and will be compared to baseline values.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taewoong Medical Co., Ltd.

Lead sponsor

Avania

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: