Pulmonary RegurgitationPREMIERNCT01356108
Pulmonic Valve REplacement Multi-discIpline EMEA Registry
An observational study of Pulmonary Regurgitation and Pulmonary Insufficiency, run by Edwards Lifesciences at 16 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pulmonary Regurgitation, Pulmonary Insufficiency, Pulmonary Stenosis
- What is being tested?
- Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)
- Type of treatment
- Medical device
- How many people
- 127 participants
- Where
- 16 sitesin 9 countries
- Study dates
- Jan 2011to 19 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All symptomatic patients with a regurgitant or stenotic pulmonary valved conduit treated by implantation of the Edwards SAPIEN™ THV.
Who may be able to join
- Symptomatic with a regurgitant or stenotic pulmonary valved conduit.
Who cannot join
- 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.
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- Presence of any prosthetic valve in the tricuspid position.
- Unstable coronary artery disease-related angina.
- Placement of the SAPIEN THV in pregnant females.
Trial locations and contacts
16 sites in 9 countries.
16 sites in 9 countries
Germany4 sites
Herz und Diabeteszentrum NRW
Bad Oeynhausen, 32545
German Heart Institute Berlin
Berlin
Deutsches Herzzentrum München
München, 80636
Universitätsklinikum Münster
Münster, 48149
United Kingdom3 sites
Royal Brompton Hospital
London, SW3 6NP
The Heart Hospital
London, W1G 8PH
Manchester Royal Infirmary
Manchester, M139WL
Italy2 sites
Ospedale Bambino Gesù
Rome, RM 00165
Policlinico San Donato
San Donato Milanese, 20097
Saudi Arabia2 sites
King Faisal Specialist Hospital & Research Centre
Riyadh, 11211
Prince Sultan Cardiac Centre
Riyadh, 11625
Israel1 site
Schneider Children's Medical Center of Israel
Petach Tikvah, 49202
Poland1 site
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, 04-628
Turkey (Türkiye)1 site
Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery
Istanbul, 34303
About this study
Official title: Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position
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.
Read the detailed description
Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.
- Being tested
- Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)
- Keywords
- Conduit, Pulmonic, Stenosis, Regurgitation, Dysfunctional
- Medical subject headings
- Pulmonary Valve Insufficiency, Respiratory Insufficiency, Pulmonary Valve Stenosis, Constriction, Pathologic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Procedure/Device Success and Freedom from device or procedure related death
Measured: 6 months
Secondary outcomes (1)
Safety and Effectiveness
Freedom from device or procedure related SAE and functional improvement
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary RegurgitationStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Ewert, MD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356108
- Sponsor's protocol ID
- 2010-11
- Acronym
- PREMIER
- Status last verified
- Nov 2018
- First submitted
- 17 May 2011
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position
- ClinicalTrials.gov ID
- NCT01356108
- Acronym / sponsor ID
- PREMIER / 2010-11
- Keywords
- Conduit, Pulmonic, Stenosis, Regurgitation, Dysfunctional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2011 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All symptomatic patients with a regurgitant or stenotic pulmonary valved conduit treated by implantation of the Edwards SAPIEN™ THV.
Key inclusion criteria (1 listed)
- Symptomatic with a regurgitant or stenotic pulmonary valved conduit.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Safety
Time frame: 6 months
Procedure/Device Success and Freedom from device or procedure related death
1 secondary outcome
Safety and Effectiveness
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Ewert, MD principal investigator
Deutsches Herzzentrum München
16 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Regurgitation and Pulmonary Insufficiency, run by Edwards Lifesciences at 16 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, United Kingdom, Italy, Saudi Arabia, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.