Back to results

PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Primary Purpose

Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

PULSTA TPV System

About this trial

This is an interventional treatment trial for Heart Diseases

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Body weight greater than or equal to 30 kilograms
Pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient >35mmHg by echocardiography
Main pulmonary artery trunk of ≥16 mm and ≤30 mm
Patients willing to provide written informed consent and comply with follow-up evaluations.

Exclusion Criteria:

Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation
Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves
Obstruction of the central veins to be approached for the TPV implantation
Coronary artery compression confirmed by angiography
A known severe allergy to Nickel
A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease
Suspected active infectious disease (e.g. endocarditis, meningitis)
Life expectancy of less than 6 months

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PULSTA TPV

Arm Description

PULSTA Transcatheter Pulmonary Valve (TPV) System

Outcomes

Primary Outcome Measures

Procedural/Device related serious adverse events at 6 months

Hemodynamic functional improvement at 6 months

Hemodynamic functional improvement is a composite of mean RVOT gradient ≤30 mmHg by continuous wave Doppler and a pulmonary regurgitant fraction <20% by cardiac magnetic resonance (MR)

Secondary Outcome Measures

Procedural Success

Procedural success is defined as the TPV implant within desired position, Right ventricle-Pulmonary artery (RV-PA) peak systolic pressure gradient <35mmHg by catheter, less mild pulmonary regurgitation by angiography, and freedom from explantation of the TPV at 24 hours post-implant.

Hemodynamic Function

Hemodynamic function will be assessed including peak RVOT pressure gradient, mean RVOT pressure gradient, right ventricle (RV) end-diastolic volume index by echocardiography or cardiac MR.

Pulmonary Regurgitant Fraction

Pulmonary regurgitant fraction (PRF) will be assessed via cardiac MRI at 6 months after the PULSTA TPV implantation.

Severity of Pulmonary Regurgitation

Severity of pulmonary regurgitation will be assessed via Doppler echocardiography.

NYHA functional classification

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

Catheter reintervention on TPV

Catheter re-intervention on PULSTA TPV is defined as any interventional catheter procedure (e.g. balloon angioplasty) that alters or adjusts, or replaces a previously implanted PULSTA TPV during a 5-year follow-up period, and the frequency will be evaluated.

Reoperation

Reoperation is defined as open surgery that alters or adjusts, or replaces a previously implanted PULSTA TPV during a 5-year follow-up period, and the frequency will be evaluated.

Procedural / Device related serious adverse events

Death (All cause / procedural/device-related)

Other adverse events

Full Information

NCT ID

NCT03983512

First Posted

June 7, 2019

Last Updated

August 14, 2023

Sponsor

Taewoong Medical Co., Ltd.

Collaborators

Factory CRO

1. Study Identification

Unique Protocol Identification Number

NCT03983512

Brief Title

PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Official Title

The PULSTA Transcatheter Pulmonary Valve (TPV) Pre-Approval Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 7, 2019 (Actual)

Primary Completion Date

July 28, 2022 (Actual)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taewoong Medical Co., Ltd.

Collaborators

Factory CRO

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.

Detailed Description

The PULSTA TPV is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (RVOT) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery system, which provides access to the right ventricular outflow tract through blood vessels. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PULSTA TPV

Arm Type

Experimental

Arm Description

PULSTA Transcatheter Pulmonary Valve (TPV) System

Intervention Type

Device

Intervention Name(s)

PULSTA TPV System

Intervention Description

PULSTA transcatheter pulmonary valve replacement.

Primary Outcome Measure Information:

Title

Procedural/Device related serious adverse events at 6 months

Time Frame

6 months

Title

Hemodynamic functional improvement at 6 months

Description

Hemodynamic functional improvement is a composite of mean RVOT gradient ≤30 mmHg by continuous wave Doppler and a pulmonary regurgitant fraction <20% by cardiac magnetic resonance (MR)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Procedural Success

Description

Time Frame

7 days

Title

Hemodynamic Function

Description

Hemodynamic function will be assessed including peak RVOT pressure gradient, mean RVOT pressure gradient, right ventricle (RV) end-diastolic volume index by echocardiography or cardiac MR.

Time Frame

5 years

Title

Pulmonary Regurgitant Fraction

Description

Pulmonary regurgitant fraction (PRF) will be assessed via cardiac MRI at 6 months after the PULSTA TPV implantation.

Time Frame

6months

Title

Severity of Pulmonary Regurgitation

Description

Severity of pulmonary regurgitation will be assessed via Doppler echocardiography.

Time Frame

5 years

Title

NYHA functional classification

Description

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

Time Frame

5 years

Title

Catheter reintervention on TPV

Description

Time Frame

5 years

Title

Reoperation

Description

Reoperation is defined as open surgery that alters or adjusts, or replaces a previously implanted PULSTA TPV during a 5-year follow-up period, and the frequency will be evaluated.

Time Frame

5 years

Title

Procedural / Device related serious adverse events

Time Frame

5 years

Title

Death (All cause / procedural/device-related)

Time Frame

5 years

Title

Other adverse events

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Body weight greater than or equal to 30 kilograms Pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient >35mmHg by echocardiography Main pulmonary artery trunk of ≥16 mm and ≤30 mm Patients willing to provide written informed consent and comply with follow-up evaluations. Exclusion Criteria: Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves Obstruction of the central veins to be approached for the TPV implantation Coronary artery compression confirmed by angiography A known severe allergy to Nickel A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease Suspected active infectious disease (e.g. endocarditis, meningitis) Life expectancy of less than 6 months

Overall Study Officials: