Aortic Valve DiseaseSAPIEN3NCT01808287
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
A study testing Edwards SAPIEN 3 Transcatheter Heart Valve in people with Aortic Valve Disease, run by Edwards Lifesciences at 17 sites in 5 countries.
Trial summary
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Jan 2013to 17 Dec 2019
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Severe symptomatic calcific aortic valve stenosis with:
- High surgical risk: STS Score ≥ 8 or EuroSCORE ≥ 15 (first 50 patients),
- High to Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (patients 51 to 150).
- Intermediate surgical risk: STS Score 4 to 8 or Logistic EuroSCORE 10 to 15 (subsequent patients); except for 20mm valve implants (STS Score > 4 or EuroSCORE ≥ 10).
- Age ≥ 75 years
- NYHA ≥ II
- Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
- Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
Who cannot join
- Non-calcified aortic valve
- Acute myocardial infarction ≤ 30 days before the intended treatment
- Untreated clinically significant coronary artery disease requiring revascularization.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve.
- Mixed aortic valve disease (with predominant aortic regurgitation)
- Preexisting bioprosthetic valve or ring in any position
- For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Germany5 sites
Kerckhoff Heartcenter
Bad Nauheim, 61231
Universitatsklinik Koln
Cologne, 50937
Universitatsklinik Essen
Essen, 45122
Universitares Herzzentrum Hamburg GmbH
Hamburg, 20251
Stadtisches Klinikum Kalsruhe
Karlsruhe, 76133
United Kingdom5 sites
Royal Victoria Hospital
Belfast, BT12 6BA
London St. Thomas's Hospital
London, SE1 7EH
King's College Hospital
London, SE5 9RS
Barts Health NHS Trust Hospital
London, W1G 8PH
Derriford Hospital
Plymouth, PL6 8DH
France4 sites
Massy, Institut Jacques Cartier
Massy, 91300
Paris, Hopital Bichat
Paris, 75018
CHU Charles Nicolle
Rouen, 76031
CHU Rangueil
Toulouse, 31059
Canada2 sites
Laval, Institut universitaire de cardiologie et de pneumologie de Quebec
Laval, Quebec, G1V4G5
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1 Y6
About this study
Official title: Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
Read the detailed description
This is a non-randomized, prospective, multicenter safety and device success study. Two hundred fifty (250) patients are planned to be enrolled at up to 20 participating investigational centers in Europe and Canada. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, hospital discharge, 30 days, 1 year and annually thereafter for a minimum of 5 years.
- Conditions
- Aortic Valve Disease
- Being tested
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Stenosis
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards SAPIEN 3 Transcatheter Heart ValveDevice
Also called TAVR, TAVI
The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement (AVR).
| Study group | Role | What they receive |
|---|---|---|
| High risk population | Experimental | SAPIEN 3 transcatheter heart valve was implanted in high risk patients Receives: Device: Edwards SAPIEN 3 Transcatheter Heart Valve |
| Intermediate risk population | Experimental | SAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients Receives: Device: Edwards SAPIEN 3 Transcatheter Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality rate
NAP
Measured: 30 days post-index procedure
Secondary outcomes (1)
safety endpoints(VARC II)
safety endpoints
composite of mortality, and major complications including THV-related dysfunction major bleeds MI new conduction abnormality new onset of AF time-related valve safety composite of valve structural deterioration
Measured: Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Webb, MD, Principal investigator, St. Paul's Hospital Vancouver (Canada)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808287
- Sponsor's protocol ID
- 2012-07
- Acronym
- SAPIEN3
- Status last verified
- Mar 2020
- First submitted
- 7 Mar 2013
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vahanian A, Urena M, Walther T, Treede H, Wendler O, Lefevre T, Spence MS, Redwood S, Kahlert P, Rodes-Cabau J, Leipsic J, Webb J. Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial. EuroIntervention. 2016 Jun 12;12(2):e235-43. doi: 10.4244/EIJV12I2A37.
PubMed 27290682Webb J, Gerosa G, Lefevre T, Leipsic J, Spence M, Thomas M, Thielmann M, Treede H, Wendler O, Walther T. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014 Dec 2;64(21):2235-43. doi: 10.1016/j.jacc.2014.09.026. Epub 2014 Nov 24.
PubMed 25456759
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve
- ClinicalTrials.gov ID
- NCT01808287
- Acronym / sponsor ID
- SAPIEN3 / 2012-07
- Conditions
- Aortic Valve Disease
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 11 Mar 2013 (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 study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
Detailed description
This is a non-randomized, prospective, multicenter safety and device success study. Two hundred fifty (250) patients are planned to be enrolled at up to 20 participating investigational centers in Europe and Canada. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, hospital discharge, 30 days, 1 year and annually thereafter for a minimum of 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk population | Experimental | Device: Edwards SAPIEN 3 Transcatheter Heart ValveSAPIEN 3 transcatheter heart valve was implanted in high risk patients |
| Intermediate risk population | Experimental | Device: Edwards SAPIEN 3 Transcatheter Heart ValveSAPIEN 3 transcatheter heart valve was implanted in intermediate risk patients |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Severe symptomatic calcific aortic valve stenosis with:
- Age ≥ 75 years
- NYHA ≥ II
- Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
- Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
Key exclusion criteria (7 listed)
- Non-calcified aortic valve
- Acute myocardial infarction ≤ 30 days before the intended treatment
- Untreated clinically significant coronary artery disease requiring revascularization.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve.
- Mixed aortic valve disease (with predominant aortic regurgitation)
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 |
|---|---|---|
| Edwards SAPIEN 3 Transcatheter Heart ValveAlso: TAVR, TAVIThe Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement (AVR). | Device | High risk population, Intermediate risk population |
Primary outcome
All-cause mortality rate
Time frame: 30 days post-index procedure
NAP
1 secondary outcome
safety endpoints(VARC II)
Time frame: Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure.
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 1 Apr 2020.
- Results publication: PubMed 27290682Vahanian A, Urena M, Walther T, Treede H, Wendler O, Lefevre T, Spence MS, Redwood S, Kahlert P, Rodes-Cabau J, Leipsic J, Webb J. Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial. EuroIntervention. 2016 Jun 12;12(2):e235-43. doi: 10.4244/EIJV12I2A37.
- Derived from this study: PubMed 25456759Webb J, Gerosa G, Lefevre T, Leipsic J, Spence M, Thomas M, Thielmann M, Treede H, Wendler O, Walther T. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014 Dec 2;64(21):2235-43. doi: 10.1016/j.jacc.2014.09.026. Epub 2014 Nov 24.
- Individual participant dataSharing planned: Undecided
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Acute Pain
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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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.
John Webb, MD principal investigator
St. Paul's Hospital Vancouver (Canada)
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards SAPIEN 3 Transcatheter Heart Valve in people with Aortic Valve Disease, run by Edwards Lifesciences at 17 sites in 5 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 8 inclusion and 7 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 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, United Kingdom, France, Canada, Italy. 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?
All-cause mortality rate (time frame: 30 days post-index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01808287, which also lists 2 linked publications.
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 1 Apr 2020.