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出境医 / 临床实验 / PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

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.

Condition or disease Intervention/treatment Phase
Heart Diseases Pulmonary Valve Regurgitation Pulmonary Valve Stenosis Tetralogy of Fallot Device: PULSTA TPV System Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The PULSTA Transcatheter Pulmonary Valve (TPV) Pre-Approval Study
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: PULSTA TPV
PULSTA Transcatheter Pulmonary Valve (TPV) System
 Device: PULSTA TPV System
PULSTA transcatheter pulmonary valve replacement.
Outcome Measures
Primary Outcome Measures :
  1. Procedural/Device related serious adverse events at 6 months [ Time Frame: 6 months ]
  2. Hemodynamic functional improvement at 6 months [ Time Frame: 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 :
  1. Procedural Success [ Time Frame: 7 days ]
    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.

  2. Hemodynamic Function [ Time Frame: 5 years ]
    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.

  3. Pulmonary Regurgitant Fraction [ Time Frame: 6months ]
    Pulmonary regurgitant fraction (PRF) will be assessed via cardiac MRI at 6 months after the PULSTA TPV implantation.

  4. Severity of Pulmonary Regurgitation [ Time Frame: 5 years ]
    Severity of pulmonary regurgitation will be assessed via Doppler echocardiography.

  5. NYHA functional classification [ Time Frame: 5 years ]
    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.

  6. Catheter reintervention on TPV [ Time Frame: 5 years ]
    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.

  7. Reoperation [ Time Frame: 5 years ]
    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.

  8. Procedural / Device related serious adverse events [ Time Frame: 5 years ]
  9. Death (All cause / procedural/device-related) [ Time Frame: 5 years ]
  10. Other adverse events [ Time Frame: 5 years ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jang Mi Ko +82 31 904 6187 ext 637 jmko@stent.net

Locations
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Germany
Deutsches Herzzentrum Munchen Recruiting
München, Germany, 80636
Italy
Policlinico San Donato Recruiting
Milan, San Donato Milanese, Italy, 20097
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Haehak-ro Jongno-gu, Korea, Republic of, 03080
Sejong General Hospital Recruiting
Bucheon, Hohyun-ro, Sosa-gu, Korea, Republic of, 14754
Severance Hospital Recruiting
Seoul, Yonsei-ro, Seodaemun-gu, Korea, Republic of, 03722
Netherlands
Erasmus Medical Center Not yet recruiting
Rotterdam, Wytemaweg, Netherlands, 3015
Utrecht University Wilhelmina Not yet recruiting
Utrecht, Netherlands, 3508
Spain
Gregorio Marañon hospital Recruiting
Madrid, Spain, 28007
University Hospital La Paz Recruiting
Madrid, Spain, 28046
Turkey
Acibadem University Hospital Active, not recruiting
Istanbul, Küçükçekmece/İstanbul, Turkey, 34303
Siyami Ersek Hospital Recruiting
Istanbul, Üsküdar/İstanbul, Turkey, 34668
Sponsors and Collaborators
Taewoong Medical Co., Ltd.
Factory CRO
Investigators
Layout table for investigator information
Study Chair: Mario Carminati, PhD. MD. Policlinico San Donato
Principal Investigator: Andreas Eicken, PhD. MD. Deutsches Herzzentrum Munchen
Principal Investigator: Jose Luis Zunzunegui, PhD. MD. Gregorio Marañon hospital
Principal Investigator: Federico Gutierrez Larraya, PhD. MD. Hospital Universitario La Paz
Principal Investigator: Ender Odemis, PhD. MD. Acibadem University Hospital
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
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE October 7, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Procedural/Device related serious adverse events at 6 months [ Time Frame: 6 months ]
  • Hemodynamic functional improvement at 6 months [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Procedural Success [ Time Frame: 7 days ]
    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 [ Time Frame: 5 years ]
    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 [ Time Frame: 6months ]
    Pulmonary regurgitant fraction (PRF) will be assessed via cardiac MRI at 6 months after the PULSTA TPV implantation.
  • Severity of Pulmonary Regurgitation [ Time Frame: 5 years ]
    Severity of pulmonary regurgitation will be assessed via Doppler echocardiography.
  • NYHA functional classification [ Time Frame: 5 years ]
    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 [ Time Frame: 5 years ]
    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 [ Time Frame: 5 years ]
    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 [ Time Frame: 5 years ]
  • Death (All cause / procedural/device-related) [ Time Frame: 5 years ]
  • Other adverse events [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
Official Title  ICMJE The PULSTA Transcatheter Pulmonary Valve (TPV) Pre-Approval Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Diseases
  • Pulmonary Valve Regurgitation
  • Pulmonary Valve Stenosis
  • Tetralogy of Fallot
Intervention  ICMJE Device: PULSTA TPV System
PULSTA transcatheter pulmonary valve replacement.
Study Arms  ICMJE Experimental: PULSTA TPV
PULSTA Transcatheter Pulmonary Valve (TPV) System
Intervention: Device: PULSTA TPV System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019) 		58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2025
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jang Mi Ko +82 31 904 6187 ext 637 jmko@stent.net
Listed Location Countries  ICMJE Germany,   Italy,   Korea, Republic of,   Netherlands,   Spain,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983512
Other Study ID Numbers  ICMJE TWTPV-E1001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Taewoong Medical Co., Ltd.
Study Sponsor  ICMJE Taewoong Medical Co., Ltd.
Collaborators  ICMJE Factory CRO
Investigators  ICMJE
Study Chair: Mario Carminati, PhD. MD. Policlinico San Donato
Principal Investigator: Andreas Eicken, PhD. MD. Deutsches Herzzentrum Munchen
Principal Investigator: Jose Luis Zunzunegui, PhD. MD. Gregorio Marañon hospital
Principal Investigator: Federico Gutierrez Larraya, PhD. MD. Hospital Universitario La Paz
Principal Investigator: Ender Odemis, PhD. MD. Acibadem University Hospital
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
PRS Account Taewoong Medical Co., Ltd.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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