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Pulmonic Valve REplacement Multi-discIpline EMEA Registry (PREMIER)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01356108
First received: May 17, 2011
Last updated: May 21, 2014
Last verified: January 2014
  Purpose

The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.


Condition Intervention
Pulmonary Regurgitation
Pulmonary Insufficiency
Pulmonary Stenosis
Device: Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Procedure/Device Success and Freedom from device or procedure related death


Secondary Outcome Measures:
  • Safety and Effectiveness [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Freedom from device or procedure related SAE and functional improvement


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: April 2017
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)
    The Edwards SAPIEN™ THV is a biological heart valve manufactured with treated bovine pericardial tissue that is mounted into a balloon expandable stainless steel open cell stent. The Edwards SAPIEN™ THV is available in two sizes (23 and 26mm) and is designed for transcatheter implantation in patients with regurgitant pulmonary valved conduit with or without stenosis. This device is commercially available and is used according the current IFU.
Detailed Description:

Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All symptomatic patients with a regurgitant or stenotic pulmonary valved conduit treated by implantation of the Edwards SAPIEN™ THV.

Criteria

Inclusion Criteria:

- Symptomatic with a regurgitant or stenotic pulmonary valved conduit.

Exclusion Criteria:

  • Angiographic evidence of coronary artery compression.
  • RV-PA pulmonary conduit size that is either too large or too small to accommodate the SAPIEN THV.
  • Thrombus or intracardiac mass in the right atrium, right ventricle, and/or pulmonic valve.
  • Severe coagulation problems and/or unable to tolerate anticoagulation/antiplatelet therapy.
  • Active bacterial endocarditis or other active infections.
  • Illeofemoral venous stenosis that may prevent the placement of the introducer sheath and/or central venous vascular tortuosities that may prevent advancement of the delivery system to the heart or into the pulmonary artery.
  • Presence of any prosthetic valve in the tricuspid position.
  • Unstable coronary artery disease-related angina.
  • Placement of the SAPIEN THV in pregnant females.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356108

Locations
Belgium
University Hospital Leuven
Leuven, Belgium, 3000
Germany
Herz und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
German Heart Institute Berlin
Berlin, Germany
Deutsches Herzzentrum München
München, Germany, 80636
Universitätsklinikum Münster
Münster, Germany, 48149
Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
Israel
Schneider Children's Medical Center of Israel
Petach Tikvah, Israel, 49202
Italy
Ospedale Bambino Gesù
Rome, Italy, RM 00165
Policlinico San Donato
San Donato Milanese, Italy, 20097
Poland
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, Poland, 04-628
Saudi Arabia
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia, 11211
Prince Sultan Cardiac Centre
Riyadh, Saudi Arabia, 11625
Turkey
Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery
Istanbul, Turkey, 34303
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
The Heart Hospital
London, United Kingdom, W1G 8PH
Manchester Royal Infirmary
Manchester, United Kingdom, M139WL
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Peter Ewert, MD German Heart Institute Berlin
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01356108     History of Changes
Other Study ID Numbers: 2010-11
Study First Received: May 17, 2011
Last Updated: May 21, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Edwards Lifesciences:
Conduit
Pulmonic
Stenosis
Regurgitation
Dysfunctional

Additional relevant MeSH terms:
Pulmonary Valve Insufficiency
Pulmonary Valve Stenosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on November 25, 2014