PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Diseases; Tetralogy of Fallot; Pulmonary Valve Stenosis; Pulmonary Valve Regurgitation
• Intervention / Treatment: Device: PULSTA TPV System

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.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • München, Germany, 80636
    • Deutsches Herzzentrum München
• Italy
  • San Donato Milanese
    • Milan, San Donato Milanese, Italy, 20097
      • Policlínico San Donato
• Korea, Republic of
  • Haehak-ro Jongno-gu
    • Seoul, Haehak-ro Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital
  • Hohyun-ro, Sosa-gu
    • Bucheon, Hohyun-ro, Sosa-gu, Korea, Republic of, 14754
      • Sejong General Hospital
  • Yonsei-ro, Seodaemun-gu
    • Seoul, Yonsei-ro, Seodaemun-gu, Korea, Republic of, 03722
      • Severance Hospital
• Netherlands
  • Utrecht, Netherlands, 3508
    • Utrecht University Wilhelmina
  • Wytemaweg
    • Rotterdam, Wytemaweg, Netherlands, 3015
      • Erasmus Medical Center
• Spain
  • Madrid, Spain, 28046
    • University Hospital La Paz
  • Madrid, Spain, 28007
    • Gregorio Marañón Hospital
• Turkey
  • Topkapı, Zetinburnu/İstanbul
    • Istanbul, Topkapı, Zetinburnu/İstanbul, Turkey, 34010
      • Koç University Hospital
  • Üsküdar/İstanbul
    • Istanbul, Üsküdar/İstanbul, Turkey, 34668
      • Siyami Ersek Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PULSTA TPV; PULSTA Transcatheter Pulmonary Valve (TPV) System	Device: PULSTA TPV System; PULSTA transcatheter pulmonary valve replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural/Device related serious adverse events at 6 months		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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural / Device related serious adverse events		5 years
Other adverse events		5 years
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.	7 days
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.	5 years
Pulmonary Regurgitant Fraction	Pulmonary regurgitant fraction (PRF) will be assessed via cardiac MRI at 6 months after the PULSTA TPV implantation.	6months
Severity of Pulmonary Regurgitation	Severity of pulmonary regurgitation will be assessed via Doppler echocardiography.	5 years
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.	5 years
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.	5 years
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.	5 years
Death (All cause / procedural/device-related)		5 years

Collaborators and Investigators

• Sponsor: Taewoong Medical Co., Ltd.
• Collaborators: Avania
• Investigators: Study Chair: Mario Carminati, PhD. MD., Policlínico San Donato; Principal Investigator: Jose Luis Zunzunegui, PhD. MD., Gregorio Marañón Hospital; Principal Investigator: Federico Gutierrez Larraya, PhD. MD., Hospital Universitario La Paz; Principal Investigator: Ahmet Çelebi, PhD. MD., Siyami Ersek Hospital; Principal Investigator: Gregor Krings, PhD. MD., Utrecht University Wilhelmina; Principal Investigator: Thomas Krasemann, PhD. MD., Erasmus Medical Center; Principal Investigator: Gi Beom Kim, PhD. MD., Seoul National University Hospital; Principal Investigator: Jae Young Choi, PhD. MD., Severance Hospital; Principal Investigator: Seong Ho Kim, PhD. MD., Sejong Hospital; Principal Investigator: Stanimir Georgiev, PhD. MD., Deutsches Herzzentrum München; Principal Investigator: Ender Odemis, PhD. MD., Koç University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): July 28, 2022
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Tetralogy of Fallot; Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis
• Other Study ID Numbers: TWTPV-E1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No