Aortic StenosisSOLVE-TAVINCT02737150
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
A study testing CoreValve Evolut R, Edwards Sapien 3 and Local anesthesia with conscious sedation in people with Aortic Stenosis, run by Helios Health Institute GmbH at 1 site in Germany.
Trial summary
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- CoreValve Evolut R, Edwards Sapien 3 and Local anesthesia with conscious sedation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Apr 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm²/m²
- Age ≥75 years and/or logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20% and/or Society of Thoracic Surgeons (STS) risk score ≥10% and/or high risk/contraindication to conventional surgical aortic valve replacement
- Native aortic valve annulus measuring 18-29 mm
- Suitability for transfemoral vascular access
- Written informed consent
Who cannot join
- Life expectancy <12 months due to comorbidities
- Cardiogenic shock or hemodynamic instability
- History of or active endocarditis
- Contraindications for transfemoral access
- Active peptic ulcer or upper gastro-intestinal bleeding <3 months
- Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
Show all 9Show fewer
- Contraindication for a specific mode of anesthesia as judged by the cardiac anesthesia representative of the Heart Team
- Active infection requiring antibiotic treatment
- Participation in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.
- Conditions
- Aortic Stenosis
- Being tested
- CoreValve Evolut R, Edwards Sapien 3, Local anesthesia with conscious sedation, General anesthesia
- 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.
CoreValve Evolut RDevice
Edwards Sapien 3Device
Local anesthesia with conscious sedationProcedure or surgery
General anesthesiaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Self-expandable valve under local anesthesia | Active comparator | CoreValve Evolut R valve under local anesthesia with conscious sedation Receives: Device: CoreValve Evolut R; Procedure: Local anesthesia with conscious sedation |
| Self-expandable valve under general anesthesia | Active comparator | CoreValve Evolut R valve under general anesthesia Receives: Device: CoreValve Evolut R; Procedure: General anesthesia |
| Balloon-expandable valve under local anesthesia | Active comparator | Edwards Sapien 3 valve under local anesthesia with conscious sedation Receives: Device: Edwards Sapien 3; Procedure: Local anesthesia with conscious sedation |
| Balloon-expandable valve under general anesthesia | Active comparator | Edwards Sapien 3 valve under under general anesthesia Receives: Device: Edwards Sapien 3; Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Device)
Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation
Measured: 30 day follow-up
Incidence of Treatment-Emergent Adverse Events (Anesthesia)
Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury
Measured: 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion1 Feb 2019
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University of Giessen, Heart Center Leipzig - University Hospital, University Hospital Schleswig-Holstein, Klinikum Links der Weser Bremen, University Hopsital Schleswig Holstein Campus Lübeck, Charite University, Berlin, Germany, University of Rostock
- Responsible party
- Principal investigator, Holger Thiele, MD, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737150
- Sponsor's protocol ID
- 15-292
- Acronym
- SOLVE-TAVI
- Status last verified
- Feb 2021
- First submitted
- 5 Apr 2016
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Stachel G, Abdel-Wahab M, de Waha-Thiele S, Desch S, Feistritzer HJ, Kitamura M, Farhan S, Eitel I, Kurz T, Thiele H. Fractal dimension of the aortic annulus: a novel predictor of paravalvular leak after transcatheter aortic valve implantation. Int J Cardiovasc Imaging. 2022 Nov;38(11):2469-2478. doi: 10.1007/s10554-022-02657-1. Epub 2022 Jun 24.
PubMed 36434335Farhan S, Stachel G, Desch S, Kurz T, Feistritzer HJ, Hartung P, Eitel I, Nef H, Doerr O, Lauten A, Landmesser U, Sandri M, Holzhey D, Borger M, Ince H, Oner A, Meyer-Saraei R, Wienbergen H, Fach A, Frey N, de Waha-Thiele S, Thiele H. Impact of moderate or severe left ventricular outflow tract calcification on clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with self- and balloon-expandable valves: a post hoc analysis from the SOLVE-TAVI trial. EuroIntervention. 2022 Oct 21;18(9):759-768. doi: 10.4244/EIJ-D-22-00156.
PubMed 35942626Feistritzer HJ, Kurz T, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius-Rauch U, Lauten A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Oner A, Meyer-Saraei R, Hambrecht R, Wienbergen H, Fach A, Augenstein T, Frey N, Konig IR, Vonthein R, Funkat AK, Berggreen AE, Heringlake M, Desch S, de Waha-Thiele S, Thiele H; SOLVE-TAVI Investigators. Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2021 May 4;77(17):2204-2215. doi: 10.1016/j.jacc.2021.03.007.
PubMed 33926657Thiele H, Kurz T, Feistritzer HJ, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius-Rauch U, Lauten A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Oner A, Meyer-Saraei R, Hambrecht R, Fach A, Augenstein T, Frey N, Konig IR, Vonthein R, Ruckert Y, Funkat AK, Desch S, Berggreen AE, Heringlake M, de Waha-Thiele S; SOLVE-TAVI Investigators. General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial. Circulation. 2020 Oct 13;142(15):1437-1447. doi: 10.1161/CIRCULATIONAHA.120.046451. Epub 2020 Aug 21.
PubMed 32819145
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)
- ClinicalTrials.gov ID
- NCT02737150
- Acronym / sponsor ID
- SOLVE-TAVI / 15-292
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Collaborators
- University of Giessen, Heart Center Leipzig - University Hospital, University Hospital Schleswig-Holstein, Klinikum Links der Weser Bremen, University Hopsital Schleswig Holstein Campus Lübeck, Charite University, Berlin, Germany, University of Rostock
- Study start
- Apr 2016
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- Apr 2021 (estimated)
- First posted
- 13 Apr 2016 (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.
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Self-expandable valve under local anesthesia | Active comparator | Device: CoreValve Evolut R, Procedure: Local anesthesia with conscious sedationCoreValve Evolut R valve under local anesthesia with conscious sedation |
| Self-expandable valve under general anesthesia | Active comparator | Device: CoreValve Evolut R, Procedure: General anesthesiaCoreValve Evolut R valve under general anesthesia |
| Balloon-expandable valve under local anesthesia | Active comparator | Device: Edwards Sapien 3, Procedure: Local anesthesia with conscious sedationEdwards Sapien 3 valve under local anesthesia with conscious sedation |
| Balloon-expandable valve under general anesthesia | Active comparator | Device: Edwards Sapien 3, Procedure: General anesthesiaEdwards Sapien 3 valve under under general anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm²/m²
- Age ≥75 years and/or logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20% and/or Society of Thoracic Surgeons (STS) risk score ≥10% and/or high risk/contraindication to conventional surgical aortic valve replacement
- Native aortic valve annulus measuring 18-29 mm
- Suitability for transfemoral vascular access
- Written informed consent
Key exclusion criteria (9 listed)
- Life expectancy <12 months due to comorbidities
- Cardiogenic shock or hemodynamic instability
- History of or active endocarditis
- Contraindications for transfemoral access
- Active peptic ulcer or upper gastro-intestinal bleeding <3 months
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 |
|---|---|---|
| CoreValve Evolut R | Device | Self-expandable valve under general anesthesia, Self-expandable valve under local anesthesia |
| Edwards Sapien 3 | Device | Balloon-expandable valve under general anesthesia, Balloon-expandable valve under local anesthesia |
| Local anesthesia with conscious sedation | Procedure or surgery | Balloon-expandable valve under local anesthesia, Self-expandable valve under local anesthesia |
| General anesthesia | Procedure or surgery | Balloon-expandable valve under general anesthesia, Self-expandable valve under general anesthesia |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Device)
Time frame: 30 day follow-up
Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation
Incidence of Treatment-Emergent Adverse Events (Anesthesia)
Time frame: 30 day follow-up
Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Derived from this study: PubMed 36434335Stachel G, Abdel-Wahab M, de Waha-Thiele S, Desch S, Feistritzer HJ, Kitamura M, Farhan S, Eitel I, Kurz T, Thiele H. Fractal dimension of the aortic annulus: a novel predictor of paravalvular leak after transcatheter aortic valve implantation. Int J Cardiovasc Imaging. 2022 Nov;38(11):2469-2478. doi: 10.1007/s10554-022-02657-1. Epub 2022 Jun 24.
- Derived from this study: PubMed 35942626Farhan S, Stachel G, Desch S, Kurz T, Feistritzer HJ, Hartung P, Eitel I, Nef H, Doerr O, Lauten A, Landmesser U, Sandri M, Holzhey D, Borger M, Ince H, Oner A, Meyer-Saraei R, Wienbergen H, Fach A, Frey N, de Waha-Thiele S, Thiele H. Impact of moderate or severe left ventricular outflow tract calcification on clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with self- and balloon-expandable valves: a post hoc analysis from the SOLVE-TAVI trial. EuroIntervention. 2022 Oct 21;18(9):759-768. doi: 10.4244/EIJ-D-22-00156.
- Derived from this study: PubMed 33926657Feistritzer HJ, Kurz T, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius-Rauch U, Lauten A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Oner A, Meyer-Saraei R, Hambrecht R, Wienbergen H, Fach A, Augenstein T, Frey N, Konig IR, Vonthein R, Funkat AK, Berggreen AE, Heringlake M, Desch S, de Waha-Thiele S, Thiele H; SOLVE-TAVI Investigators. Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2021 May 4;77(17):2204-2215. doi: 10.1016/j.jacc.2021.03.007.
- Derived from this study: PubMed 32819145Thiele H, Kurz T, Feistritzer HJ, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius-Rauch U, Lauten A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Oner A, Meyer-Saraei R, Hambrecht R, Fach A, Augenstein T, Frey N, Konig IR, Vonthein R, Ruckert Y, Funkat AK, Desch S, Berggreen AE, Heringlake M, de Waha-Thiele S; SOLVE-TAVI Investigators. General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial. Circulation. 2020 Oct 13;142(15):1437-1447. doi: 10.1161/CIRCULATIONAHA.120.046451. Epub 2020 Aug 21.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoreValve Evolut R, Edwards Sapien 3 and Local anesthesia with conscious sedation in people with Aortic Stenosis, run by Helios Health Institute GmbH at 1 site in Germany.
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 5 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
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?
Incidence of Treatment-Emergent Adverse Events (Device) (time frame: 30 day follow-up). The study lists 2 primary outcomes in all. 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 NCT02737150, which also lists 4 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 18 Feb 2021.