Pulmonic Valve REplacement Multi-discIpline EMEA Registry (PREMIER)
This study is ongoing, but not recruiting participants.
Sponsor:
Edwards Lifesciences
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01356108
First received: May 17, 2011
Last updated: March 6, 2013
Last verified: March 2013
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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 |
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:
Detailed Description:
-
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.
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
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 | |
| Turkey | |
| Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery | |
| Istanbul, Turkey, 34303 | |
| United Kingdom | |
| The Heart Hospital | |
| London, United Kingdom, W1G 8PH | |
| Royal Brompton Hospital | |
| London, United Kingdom, SW3 6NP | |
| 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: | March 6, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Edwards Lifesciences:
|
Conduit Pulmonic Stenosis Regurgitation Dysfunctional |
Additional relevant MeSH terms:
|
Constriction, Pathologic Pulmonary Valve Insufficiency Pulmonary Valve Stenosis Pathological Conditions, Anatomical |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |
ClinicalTrials.gov processed this record on June 17, 2013