AzTrials
AzTrials

Aortic Valve StenosisSCOPE INCT03011346

Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis.

A study testing Symetis ACURATE neo/TF transfemoral TAVI system and Edwards Sapien 3 Transcatheter Heart Valve in people with Aortic Valve Stenosis, run by Insel Gruppe AG, University Hospital Bern at 20 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
Symetis ACURATE neo/TF transfemoral TAVI system and 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
739 participants
Where
20 sitesin 4 countries
Study dates
8 Feb 2017to 16 Feb 2022
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

  • Patient with severe aortic stenosis defined by an aortic valve area (AVA) < 1cm2 or AVA indexed to body surface area (BSA) of < 0.6 cm2/m2, including low-flow severe aortic stenosis defined by stroke volume index (SVI) < 35ml/m2, as assessed by integration of echocardiographic and invasive measurements
  • Subject is symptomatic (heart failure symptoms with New York Heart Association (NYHA) Functional Class > I, angina or syncope)
  • Patient is considered at increased risk for mortality if undergoing conventional surgical aortic valve replacement or judged as not operable as determined either
  • by a Logistic EuroSCORE > 20 % OR
  • by a STS-PROM score > 10% OR
  • by the heart team consisting of at least one cardiologist and cardiac surgeon based on the integration of individual clinical and anatomical factors not captured by risk-scores, the patient's age, frailty and life-expectancy
Show all 11Show fewer
  • The heart team agrees on eligibility of the patient for participation and that TAVI by transfemoral access constitutes the most appropriate treatment modality, from which the patient will likely benefit most
  • Aortic annulus dimensions suitable for both valve types (area range: 338-573 mm2 AND perimeter range: 66-85 mm) based on ECG-gated multislice computed tomographic measurements. Findings of transesophageal echocardiography (TEE) and conventional aortography should be integrated in the anatomic assessment if available
  • Arterial aorto-iliac-femoral axis suitable for transfemoral access with a minimum access vessel diameter ≥ 6 mm as assessed by multislice computed tomographic angiography and/or conventional angiography
  • Written informed consent of the patient or her/his legal representative
  • Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up

Who cannot join

  • Non-valvular aortic stenosis
  • Congenital aortic stenosis or unicuspid or bicuspid aortic valve
  • Non-calcific acquired aortic stenosis
  • Anatomy not appropriate for transfemoral transcatheter aortic valve implantation due to size of the aortic annulus or degree or eccentricity of calcification of the native aortic valve or tortuosity of the aorta or ilio-femoral arteries
  • Emergency procedure including patients in cardiogenic shock (low cardiac output, vasopressor dependence, mechanical hemodynamic support)
  • Severely reduced left ventricular (LV) function (ejection fraction < 20%)
Show all 19Show fewer
  • Pre-existing prosthetic heart valve in aortic position
  • Presence of mitral valve prosthesis
  • Concomitant planned procedure except for percutaneous coronary intervention (PCI)
  • Planned non-cardiac surgery within 30 days
  • Stroke within 30 days of the procedure.
  • Myocardial infarction within 30 days of the procedure (except type 2)
  • Evidence of intra-cardiac mass, thrombus or vegetation
  • Severe coagulation conditions
  • Inability to tolerate anticoagulation/anti-platelet therapy
  • Active bacterial endocarditis or other active infections
  • Hypertrophic cardiomyopathy with or without obstruction
  • Contraindication to contrast media or allergy to nitinol
  • Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol

Trial locations and contacts

20 sites in 4 countries.

20 sites in 4 countries

Germany15 sites

  • Klinkum Augsburg

    Augsburg, 86156

  • Zentralklinik Bad Berka

    Bad Berka, 99437

  • Herz- und Gefässzentrum Bad Beversen

    Bad Bevensen, 29549

  • Kerckhoff-Klinik

    Bad Nauheim, 61231

  • Herz- und Gefäss-Klinik GmbH Bad Neustadt

    Bad Neustadt an der Saale, Bad Neustadt, 97616

  • Herzzentrum Uniklinik Köln

    Cologne, 50931

  • St.-Johannes-Hospital

    Dortmund, 44137

  • Herzzentrum Dresden

    Dresden, 01307

  • Universitäres Herzzentrum Hamburg GmbH

    Hamburg, 20251

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133

  • ViDia Kliniken

    Karlsruhe, 76135

  • Klinik für Herzchirurgie Karlsruhe

    Karlsruhe, 76185

  • Herzzentrum Leipzig

    Leipzig, 04289

  • Deutsches Herzzentrum München

    München, 80636

  • Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie

    Regensburg, 93053

Other trials in Germany

Switzerland3 sites

  • Bern University Hospital

    Bern, 3010

  • Luzerner Kantonsspital

    Lucerne, 6000

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Netherlands1 site

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

United Kingdom1 site

  • St Thomas' Hospital

    London, SE1 7EH

Other trials in United Kingdom

About this study

Official title: Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis for Transcatheter Aortic Valve Implantation by Transfemoral Approach.

Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). Many novel devices are currently being developed and established transcatheter heart valves undergo design reiterations to address limitations and reduce complication rates associated with the device and implantation procedure. However, device comparisons by use of randomized trials are scarce in particular for newer generation transcatheter valves. The aim of this study is to assess non-inferiority of the self-expandable Symetis ACURATE neo/TF in comparison to the balloon-expandable Edwards SAPIEN 3 transcatheter aortic valve bioprosthesis with regard to early safety and clinical efficacy at 30 days.

Read the detailed description

Background:

Transcatheter aortic valve implantation (TAVI) is an established and valuable treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). The use of TAVI is rapidly expanding worldwide and the indications for TAVI are widening into lower risk populations in view of favorable outcomes among high and intermediate risk patients. Many novel devices are currently developed or established devices undergo design reiterations to address limitations, such as vascular access complications, paravalvular regurgitation, and atrio-ventricular conductance disturbances. However, device comparisons by use of randomized trials are scarce in particular for newer generation transcatheter valves.

The Symetis ACURATE neo/TF, a self-expandable transcatheter valve delivered via transfemoral access, gained Conformité Européenne (CE) marking in September 2014 after showing favorable procedural and short term results. The SCOPE I trial will compare its performance to the balloon-expandable Edwards SAPIEN 3, a widely used and well-established transcatheter heart valve of the second generation, in a randomized fashion.

Objectives:

The primary objective is the comparison of the Symetis ACURATE neo/TF to the Edwards SAPIEN 3 transcatheter aortic bioprosthesis with regard to early safety and clinical efficacy at 30 days. Secondary objectives involve the comparison between the two devices with regard to secondary clinical and echocardiographic endpoints at 30 days, 1 year and 3 years.

Methods:

Sample Size: Based on an anticipated incidence proportion of 22% for the primary non-hierarchical composite endpoint at 30 days in both treatment arms, a non-inferiority margin of 7.7%, a power of 80%, a one-tailed significance level of α = 0.05, and a low attrition rate, the total required sample size amounts to 730 patients.

Design: Patients will be allocated to the Symetis ACURATE neo/TF or the Edwards SAPIEN 3 bioprosthesis at a 1:1 ratio by means of a randomly permuted block randomisation stratified on study center and Society of Thoracic Surgeons' predicted risk of mortality score (STS-PROM) strata (< 3%, ≥ 3 to < 8%, ≥ 8%).

Analysis: Estimates of the risk-differences between the two treatment arms with regard to the primary endpoint will be pooled over the predefined STS-PROM strata by means of the Cochran-Mantel-Haenszel method and Wald-type confidence limits will be calculated using the Sato variance estimator. The non-inferiority assumption will be tested at a one-sided significance level with a type I error rate (α) = 0.05. The analysis of the primary composite endpoint will be conducted according to the intention-to-treat (ITT) and the per protocol (PP) principle and non-inferiority should be claimed only if met by both.

In case non-inferiority is established, a superiority analysis will be performed using a two-tailed significance level with a type I error rate of α = 0.05. Further secondary analyses will evaluate between group differences in relation to demographic, clinical, procedural, functional and imaging characteristics. Pre-specified subgroup analyses will be conducted by use of appropriate interaction tests contrasting categories of sex, STS-PROM score (< 3%, ≥ 3 to < 8%, ≥ 8%), left ventricular ejection fraction (< 50% vs. ≥ 50%), and native aortic valve eccentricity index (≤ 0.25 vs. > 0.25).

Being tested
Symetis ACURATE neo/TF transfemoral TAVI system, Edwards Sapien 3 Transcatheter Heart Valve
Keywords
Aortic valve stenosis, Transcatheter aortic valve implantation, Transcatheter aortic valve replacement, Randomized controlled trial
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Symetis ACURATE neo/TF transfemoral TAVI systemDevice

    Transcatheter aortic valve implantation of a Symetis ACURATE neo/TF bioprosthesis by transfemoral access, pre-dilatation mandatory.

  • Edwards Sapien 3 Transcatheter Heart ValveDevice

    Transcatheter aortic valve implantation of an Edwards Sapien 3 bioprosthesis by transfemoral access.

Study groups in NCT03011346
Study groupRoleWhat they receive
Symetis ACURATE neo/TF transfemoral TAVI systemActive comparatorSymetis ACURATE neo/TF transfemoral TAVI system: self-expandable transcatheter aortic bioprosthesis, support frame made of nitinol, supra-annular processed trileaflet porcine pericardial valve and an outer skirt to mitigate paravalvular regurgitation (manufactured by Symetis SA, Ecublens, Switzerland)
Receives: Device: Symetis ACURATE neo/TF transfemoral TAVI system
Edwards Sapien 3 Transcatheter Heart ValveActive comparatorEdwards SAPIEN 3 Transcatheter Heart Valve system: balloon-expandable transcatheter aortic bioprosthesis, support frame made of cobalt-chromium, three leaflets constructed of processed bovine pericardial tissue and an outer polyethylene terephthalate (PET) sealing cuff to mitigate paravalvular regurgitation (manufactured by Edwards Lifesciences, Inc., Irvine, California, USA)
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.

  1. Modified* combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)

    (* "NYHA class III or IV" is omitted due to lack of objectiveness in its ascertainment)

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Life-threatening or disabling bleeding
    • Acute kidney injury (stage 2 or 3, including renal replacement therapy)
    • Coronary artery obstruction requiring intervention
    • Major vascular complication
    • Valve related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, TAVI or SAVR in a separate intervention)
    • Rehospitalization for valve-related symptoms or worsening congestive heart failure
    • Valve-related dysfunction: prosthetic aortic valve stenosis (mean gradient ≥ 20 mmHg, effective orifice area ≤ 0.9-1.1cm2 and/or Doppler velocity index < 0.35) AND/OR ≥ moderate prosthetic valve regurgitation)

    Measured: 30 days

Secondary outcomes (20)

  1. Device success

    Combined endpoint composed of:

    • Absence of procedural mortality AND
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
    • Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation)

    Measured: 30 days

  2. Early safety

    Combined endpoint composed of:

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Life-threatening or disabling bleeding
    • Acute kidney injury - stage 2 or 3 (including renal replacement therapy)
    • Coronary artery obstruction requiring intervention
    • Major vascular complication
    • Valve-related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, TAVI, or SAVR)

    Measured: 30 days

  3. Clinical efficacy

    Combined endpoint composed of:

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
    • NYHA class III or IV
    • Valve-related dysfunction (mean aortic valve gradient ≥ 20 mmHg, effective orifice area (EOA) ≤ 0.9-1.1 cm2 and/or Doppler velocity index (DVI) < 0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)

    Measured: 30 days

  4. Time-related valve safety

    Combined endpoint composed of:

    • Structural valve deterioration (Valve-related dysfunction (mean aortic valve gradient ≥ 20 mmHg, EOA ≤ 0.9-1.1 cm2 (depending on body surface area (BSA)) and/or DVI < 0.35 m/s AND/OR moderate or severe prosthetic valve regurgitation)) OR Requiring repeat procedure (TAVI or SAVR)
    • Prosthetic valve endocarditis
    • Prosthetic valve thrombosis
    • Thrombo-embolic events (e.g. stroke)
    • VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)

    Measured: 30 days, 1 year

  5. All-cause mortality

    Measured: 30 days, 1 year, 3 years

  6. All stroke (disabling and non-disabling)

    Measured: 30 days, 1 year, 3 years

  7. Life-threatening or disabling bleeding

    • Fatal bleeding (Bleeding Academic Research Consortium (BARC) type 5)OR
    • Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR
    • Bleeding causing hypovolaemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR
    • Overt source of bleeding with drop in haemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units (BARC type 3b)

    Measured: 30 days, 1 year, 3 years

  8. Acute kidney injury (stage 2 or 3, including renal replacement therapy)

    • Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline) OR Urine output <0.5 mL/kg/h for >12 but <24 h
    • Stage 3: Increase in serum creatinine to ≥300% (>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR Urine output <0.3 ml/kg/h for ≥24 h OR Anuria for ≥12 h Notes: The increase in creatinine must occur within 48 h. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.

    Measured: 30 days, 1 year, 3 years

  9. Coronary artery obstruction requiring intervention

    Measured: 30 days, 1 year, 3 years

  10. Major vascular complication

    • Aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudo-aneurysm OR
    • Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, haematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischaemia, or neurological impairment OR
    • Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR
    • Use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment OR
    • Any new ipsilateral lower extremity ischaemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR
    • Surgery for access site-related nerve injury OR
    • Permanent access site-related nerve injury

    Measured: 30 days, 1 year, 3 years

  11. Valve related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, TAVI or SAVR in a separate intervention)

    Measured: 30 days, 1 year, 3 years

  12. Rehospitalization for valve-related symptoms or worsening congestive heart failure

    Measured: 30 days, 1 year, 3 years

  13. Valve-related dysfunction: prosthetic aortic valve stenosis AND/OR ≥ moderate prosthetic valve regurgitation

    Prosthetic aortic valve stenosis: mean gradient ≥ 20 mmHg, EOA ≤ 0.9-1.1cm2 and/or DVI < 0.35)

    Measured: 30 days, 1 year, 3 years

  14. Conversion to open heart surgery

    Measured: procedural

  15. Annular rupture

    Measured: procedural

  16. New pacemaker implantation

    Measured: 30 days, 1 year, 3 years

  17. Valve thrombosis

    Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. Note that valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve-related should not be reported as valve thrombosis.

    Measured: 30 days, 1 year, 3 years

  18. Mean trans-prosthetic aortic gradient

    Measured: 30 days, 1 year, 3 years

  19. Aortic regurgitation

    Measured: 30 days, 1 year, 3 years

  20. Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 score

    Measured: 30 days, 1 year, 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2017 (estimated)
  2. Study start8 Feb 2017
  3. Primary completion2 May 2019
  4. Study completion16 Feb 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
739 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03011346
Sponsor's protocol ID
V 4.0, 13.08.2018
Acronym
SCOPE I
Status last verified
Mar 2022
First submitted
2 Jan 2017
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lanz J, Kim WK, Walther T, Burgdorf C, Mollmann H, Linke A, Redwood S, Thilo C, Hilker M, Joner M, Thiele H, Conzelmann L, Conradi L, Kerber S, Schymik G, Prendergast B, Husser O, Stortecky S, Heg D, Juni P, Windecker S, Pilgrim T; SCOPE I investigators. Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial. Lancet. 2019 Nov 2;394(10209):1619-1628. doi: 10.1016/S0140-6736(19)32220-2. Epub 2019 Sep 27.

    PubMed 31570258

  • Tomii D, Lanz J, Heg D, Cozzi O, Thiele H, Kim WK, Joner M, Conradi L, Toggweiler S, Prendergast B, Windecker S, Pilgrim T; SCOPE I Investigators. Sex-Specific Differences in Patient-Centered Outcomes After Transcatheter Aortic Valve Replacement. JACC Adv. 2026 Aug 13:103175. doi: 10.1016/j.jacadv.2026.103175. Online ahead of print.

    PubMed 42663370

  • Tomii D, Lanz J, Heg D, Thiele H, Kim WK, Joner M, Mollmann H, Conradi L, Thilo C, Toggweiler S, Prendergast B, Windecker S, Pilgrim T; SCOPE I Investigators. Relationship between baseline patient-reported health status and patient-centered outcomes after transcatheter aortic valve replacement. Am Heart J. 2026 Oct;300:107495. doi: 10.1016/j.ahj.2026.107495. Epub 2026 May 26.

    PubMed 42203165

  • Tomii D, Lanz J, Thiele H, Heg D, Kim WK, Joner M, Mollmann H, Burgdorf C, Linke A, Redwood S, Hilker M, Conradi L, Kerber S, Thilo C, Toggweiler S, Walther T, Prendergast B, Windecker S, Pilgrim T. Obstructive Coronary Artery Disease and Health Status in Transcatheter Aortic Valve Replacement: A Post Hoc Analysis of the SCOPE I Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2547111. doi: 10.1001/jamanetworkopen.2025.47111.

    PubMed 41364435

  • Lanz J, Mollmann H, Kim WK, Burgdorf C, Linke A, Redwood S, Hilker M, Joner M, Thiele H, Conzelmann L, Conradi L, Kerber S, Thilo C, Toggweiler S, Prendergast B, Husser O, Stortecky S, Deckarm S, Kunzi A, Heg D, Walther T, Windecker S, Pilgrim T; SCOPE I Investigators. Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve. Circ Cardiovasc Interv. 2023 Jul;16(7):e012873. doi: 10.1161/CIRCINTERVENTIONS.123.012873. Epub 2023 Jul 7.

    PubMed 37417229

  • Kim WK, Walther T, Burgdorf C, Mollmann H, Linke A, Redwood S, Thilo C, Hilker M, Joner M, Thiele H, Conzelmann L, Conradi L, Kerber S, Schymik G, Prendergast B, Husser O, Blumenstein J, Stortecky S, Heg D, Kunzi A, Juni P, Windecker S, Pilgrim T, Lanz J; SCOPE I Investigators. One-Year Outcomes of a Randomized Trial Comparing a Self-Expanding With a Balloon-Expandable Transcatheter Aortic Valve. Circulation. 2021 Mar 23;143(12):1267-1269. doi: 10.1161/CIRCULATIONAHA.120.052251. Epub 2021 Mar 22. No abstract available.

    PubMed 33750210

Questions about this trial

What is this clinical trial studying?

A study testing Symetis ACURATE neo/TF transfemoral TAVI system and Edwards Sapien 3 Transcatheter Heart Valve in people with Aortic Valve Stenosis, run by Insel Gruppe AG, University Hospital Bern at 20 sites in 4 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 11 inclusion and 19 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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany, Switzerland, Netherlands, United Kingdom. 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?

Modified* combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) (time frame: 30 days). 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 NCT03011346, which also lists 6 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 10 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in