Clinical trial NCT03983512: PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
Official title: The PULSTA Transcatheter Pulmonary Valve (TPV) Pre-Approval Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Diseases
Pulmonary Valve Regurgitation
Pulmonary Valve Stenosis
Tetralogy of Fallot
Lead sponsor: Taewoong Medical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2019-06-12
Enrollment: 58
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Procedural/Device related serious adverse events at 6 months
timeFrame: 6 months
measure: Hemodynamic functional improvement at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Procedural Success
timeFrame: 7 days
measure: Hemodynamic Function
timeFrame: 5 years
measure: Pulmonary Regurgitant Fraction
timeFrame: 6months
measure: Severity of Pulmonary Regurgitation
timeFrame: 5 years
measure: NYHA functional classification
timeFrame: 5 years
measure: Catheter reintervention on TPV
timeFrame: 5 years
measure: Reoperation
timeFrame: 5 years
measure: Procedural / Device related serious adverse events
timeFrame: 5 years
measure: Death (All cause / procedural/device-related)
timeFrame: 5 years
measure: Other adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: München
country: Germany
facility: Deutsches Herzzentrum Munchen
city: Milan
country: Italy
facility: Policlinico San Donato
state: San Donato Milanese
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Haehak-ro Jongno-gu
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
state: Hohyun-ro, Sosa-gu
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Yonsei-ro, Seodaemun-gu
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Wytemaweg
city: Utrecht
country: Netherlands
facility: Utrecht University Wilhelmina
city: Madrid
country: Spain
facility: Gregorio Marañon hospital
city: Madrid
country: Spain
facility: University Hospital La Paz
city: Istanbul
country: Turkey
facility: Koc University Hospital
state: Topkapı, Zetinburnu/İstanbul
city: Istanbul
country: Turkey
facility: Siyami Ersek Hospital
state: Üsküdar/İstanbul
Study officials:
affiliation: Policlinico San Donato
name: Mario Carminati, PhD. MD.
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Munchen
name: Stanimir Georgiev, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gregorio Marañon hospital
name: Jose Luis Zunzunegui, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Paz
name: Federico Gutierrez Larraya, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Koc University Hospital
name: Ender Odemis, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Siyami Ersek Hospital
name: Ahmet Çelebi, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Utrecht University Wilhelmina
name: Gregor Krings, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Thomas Krasemann, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Gi Beom Kim, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Jae Young Choi, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sejong General Hospital
name: Seong Ho Kim, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
References: