Transcatheter Aortic Valve ReplacementPhase 3SOLOTAVINCT06518317
Short Versus Long Antiplatelet Therapy After TAVI
A Phase 3 study testing Aspirin in people with Transcatheter Aortic Valve Replacement, run by University Hospital, Caen at 1 site in France.
Trial summary
The goal of this clinical trial is to learn if reducing the duration of treatment by aspirin to 3 months (short treatment regimen) after percutaneous aortic valve replacement is as safe and efficient as the routine lifetime treatment by aspirin (standard treatment regimen). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- What is being tested?
- Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2024to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Male or, post-menopausal -with no menses for 12 months without an alternative medical cause- or permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy- female
- Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33
- Successful access, delivery of the device, and retrieval of the delivery system
- Correct positioning of a single prosthetic heart valve into the proper anatomical location
- Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access-related, or cardiac structural complication
Show all 9Show fewer
- Written informed consent
- Social security affiliated
- French speaking
Who cannot join
- Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI3
- Alternative non-femoral-approach TAVI: apical, direct trans-aortic, subclavian, axillary or carotid approaches
- TAVI for other indications than aortic stenosis (pure aortic regurgitation)
- Valve in valve TAVI
- Any indication for long term antiplatelet therapy: (e.g. coronary artery disease, cerebrovascular disease, peripheral arterial disease…) at any time prior to randomization
- Any indication for oral anticoagulation: (e.g. atrial fibrillation, deep vein thrombosis, pulmonary embolism, ventricular thrombus…) at any time prior to randomization
Show all 17Show fewer
- Patients on long term antiplatelet or anticoagulant therapy prior to TAVI for any other indication than TAVI
- Any contraindication to long term antiplatelet therapy (e.g. allergy or intolerance to aspirin, major bleeding, high bleeding risk, thrombocytopenia < 50 000, major haemostasis disorder…)
- Women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy-
- Adult with protective measures (tutorship, curatorship)
- Patients considered as vulnerable by the investigators because of medical, psychological or social conditions:
- Patients with known or discovered severe cognitive impairment
- Patients with treated or untreated severe psychological or psychiatric conditions
- Patients with uncorrected severe hearing or visual handicap
- Patients with addictive alcohol, drug or substance abuse
- Patients with protective measures (guardianship, tutorship, curatorship)
- Any other condition considered by the investigators as not warranting informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14990
Farzin Beygui, MD, PhD, 33 231065750, beygui-f@CHU-Caen.FR
About this study
The goal of this clinical trial is to learn if reducing the duration of treatment by aspirin to 3 months (short treatment regimen) after percutaneous aortic valve replacement is as safe and efficient as the routine lifetime treatment by aspirin (standard treatment regimen).
The main questions it aims to answer are:
Read more
Does the reduction of the duration of aspirin reduces rates of bleeding without increasing the risk of cardiovascular events.
Researchers will compare a short treatment by aspirin (3 months) to a long treatment by aspirin (12 months) after percutaneous replacement of the aortic valve.
Participants will:
Take aspirin for 3 months in one group or 12 months in another group Be contacted by phone or visit the clinic at 3, 4, 6, 8, 10 and 12 months after hospital discharge Keep a diary of any bleeding or cardiovascular events occurring during the study period
Read the detailed description
INTRODUCTION AND RATIONALE Aortic stenosis (AS) is the most common heart valve disease requiring intervention among elderly patients. Surgical aortic valve replacement which was the only curative treatment of AS has been challenged during the past decade by the trans-aortic valve implantation (TAVI) which is becoming the first line treatment of such condition.
Antithrombotic therapy after TAVI remains a matter of debate. In patients with no indication for antiplatelet therapy, aspirin alone is recommended for lifetime. However, after bioprosthetic surgical valve replacement, aspirin is to be discontinued 3 months after surgery and there is no evidence that it should be continued in patients after TAVI with no other indication for such therapy (more than half of low risk and a third of intermediate risk TAVI patients). Aspirin as compared to placebo in the setting of primary prevention is associated with a 38% relative risk increase of major bleeding in elderly patients with no benefit in terms of mortality or cardiovascular events.
Hence there is a major gap of knowledge on whether aspirin is beneficial or harmful if continued more than 3 months as recommended after successful TAVI in absence of another indication, as most such patients are elderly and at high bleeding risk.
STUDY POPULATION Adult patients with successful transfemoral TAVI for symptomatic aortic stenosis with no indication for long term antiplatelet or anticoagulant therapy. This represents approximately 30% of the TAVI patient population.
STUDY DESIGN Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial nested in an ongoing prospective nationwide registry RANDOMIZATION All potentially eligible patients will be included after successful TAVI at hospital discharge to be randomized to receive the experimental or control strategy. Randomization will be performed at hospital discharge (visit 0) after revision of inclusion/exclusion criteria. Randomization will be stratified by center and type of valve (balloon expandable or self-expandable). A hierarchical test procedure will be used for the analysis of the endpoints. A hierarchical test procedure will be used for the analysis of the primary and principal secondary endpoints.
EXPERIMENTAL ARM Single antiplatelet therapy 75 to 100 mg aspirin for 3 months after TAVI followed by aspirin discontinuation CONTROL ARM Long term (lifetime) single antiplatelet therapy75 to 100 mg aspirin therapy after TAVI PRIMARY END POINT Net clinical benefit defined by the composite of all cause death, myocardial infarction, ischemic or hemorrhagic stroke and major or disabling bleeding assessed at 12 months follow-up NUMBER OF PATIENTS TO BE INCLUDED 1400 (700 in each group)
- Conditions
- Transcatheter Aortic Valve Replacement
- Being tested
- Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Short duration of aspirin (3 months) is compared to long duration of aspirin (12 months)
| Study group | Role | What they receive |
|---|---|---|
| Short treatment | Experimental | Single antiplatelet therapy 75 to 100 mg aspirin for 3 months after TAVI followed by aspirin discontinuation Receives: Drug: Aspirin |
| long treatment | Active comparator | Long term (lifetime) single antiplatelet therapy75 to 100 mg aspirin therapy after TAV Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net clinical benefit
The composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system injury and non-procedure-related major or disabling bleeding VARC 3 types 2 or 3
Measured: 12 months after randomisation
Secondary outcomes (3)
Non-procedure-related bleeding
VARC 3 classification 1 to 4 bleeding
Measured: 12 months
Major or disabling or life threatening bleeding
VARC 3 classification 2 or 3 bleeding
Measured: 12 months
Major cardiovascular events
The composite of all cause death, type 1 myocardial infarction based on the universal definition or stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start21 Nov 2024
- Primary completionNov 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518317
- Sponsor's protocol ID
- 2023-508208-40-00
- Other IDs
- 2023
- Acronym
- SOLOTAVI
- Status last verified
- Mar 2025
- First submitted
- 18 Jul 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing may be considered if authorised by PI and promoter
Publications
Beygui F, Caussin C, Marliere S, Bonnet G, Durand E, Lhermusier T, Morelle JF, Delepine S, Souteyrand G, Ghostine S, Van Belle E, Barthelemy O, Akodad M, Cayla G, Chamandi C, Chemouni F, Parienti JJ, Bouleti C, Eltchaninoff H; SOLOTAVI Investigators. Rationale for Early Discontinuation of Aspirin After Transcatheter Aortic Valve Implantation: Design of the SOLOTAVI Randomized Trial. Am Heart J. 2026 Oct 28:107634. doi: 10.1016/j.ahj.2026.107634. Online ahead of print.
PubMed 42951053
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Versus Long Antiplatelet Therapy After TAVI
- ClinicalTrials.gov ID
- NCT06518317
- Acronym / sponsor ID
- SOLOTAVI / 2023-508208-40-00
- Conditions
- Transcatheter Aortic Valve Replacement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 24 Jul 2024 (actual)
- 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 goal of this clinical trial is to learn if reducing the duration of treatment by aspirin to 3 months (short treatment regimen) after percutaneous aortic valve replacement is as safe and efficient as the routine lifetime treatment by aspirin (standard treatment regimen).
The main questions it aims to answer are:
Does the reduction of the duration of aspirin reduces rates of bleeding without increasing the risk of cardiovascular events.
Researchers will compare a short treatment by aspirin (3 months) to a long treatment by aspirin (12 months) after percutaneous replacement of the aortic valve.
Participants will:
Take aspirin for 3 months in one group or 12 months in another group Be contacted by phone or visit the clinic at 3, 4, 6, 8, 10 and 12 months after hospital discharge Keep a diary of any bleeding or cardiovascular events occurring during the study period
Detailed description
INTRODUCTION AND RATIONALE Aortic stenosis (AS) is the most common heart valve disease requiring intervention among elderly patients. Surgical aortic valve replacement which was the only curative treatment of AS has been challenged during the past decade by the trans-aortic valve implantation (TAVI) which is becoming the first line treatment of such condition.
Antithrombotic therapy after TAVI remains a matter of debate. In patients with no indication for antiplatelet therapy, aspirin alone is recommended for lifetime. However, after bioprosthetic surgical valve replacement, aspirin is to be discontinued 3 months after surgery and there is no evidence that it should be continued in patients after TAVI with no other indication for such therapy (more than half of low risk and a third of intermediate risk TAVI patients). Aspirin as compared to placebo in the setting of primary prevention is associated with a 38% relative risk increase of major bleeding in elderly patients with no benefit in terms of mortality or cardiovascular events.
Hence there is a major gap of knowledge on whether aspirin is beneficial or harmful if continued more than 3 months as recommended after successful TAVI in absence of another indication, as most such patients are elderly and at high bleeding risk.
STUDY POPULATION Adult patients with successful transfemoral TAVI for symptomatic aortic stenosis with no indication for long term antiplatelet or anticoagulant therapy. This represents approximately 30% of the TAVI patient population.
STUDY DESIGN Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial nested in an ongoing prospective nationwide registry RANDOMIZATION All potentially eligible patients will be included after successful TAVI at hospital discharge to be randomized to receive the experimental or control strategy. Randomization will be performed at hospital discharge (visit 0) after revision of inclusion/exclusion criteria. Randomization will be stratified by center and type of valve (balloon expandable or self-expandable). A hierarchical test procedure will be used for the analysis of the endpoints. A hierarchical test procedure will be used for the analysis of the primary and principal secondary endpoints.
EXPERIMENTAL ARM Single antiplatelet therapy 75 to 100 mg aspirin for 3 months after TAVI followed by aspirin discontinuation CONTROL ARM Long term (lifetime) single antiplatelet therapy75 to 100 mg aspirin therapy after TAVI PRIMARY END POINT Net clinical benefit defined by the composite of all cause death, myocardial infarction, ischemic or hemorrhagic stroke and major or disabling bleeding assessed at 12 months follow-up NUMBER OF PATIENTS TO BE INCLUDED 1400 (700 in each group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Short treatment | Experimental | Drug: AspirinSingle antiplatelet therapy 75 to 100 mg aspirin for 3 months after TAVI followed by aspirin discontinuation |
| long treatment | Active comparator | Drug: AspirinLong term (lifetime) single antiplatelet therapy75 to 100 mg aspirin therapy after TAV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18
- Male or, post-menopausal -with no menses for 12 months without an alternative medical cause- or permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy- female
- Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33
- Written informed consent
- Social security affiliated
Key exclusion criteria (17 listed)
- Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI3
- Alternative non-femoral-approach TAVI: apical, direct trans-aortic, subclavian, axillary or carotid approaches
- TAVI for other indications than aortic stenosis (pure aortic regurgitation)
- Valve in valve TAVI
- Any indication for long term antiplatelet therapy: (e.g. coronary artery disease, cerebrovascular disease, peripheral arterial disease…) at any time prior to randomization
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 |
|---|---|---|
| AspirinShort duration of aspirin (3 months) is compared to long duration of aspirin (12 months) | Drug | Short treatment, long treatment |
Primary outcome
Net clinical benefit
Time frame: 12 months after randomisation
The composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system injury and non-procedure-related major or disabling bleeding VARC 3 types 2 or 3
3 secondary outcomes
Non-procedure-related bleeding
Time frame: 12 months
Major or disabling or life threatening bleeding
Time frame: 12 months
Major cardiovascular events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 42951053Beygui F, Caussin C, Marliere S, Bonnet G, Durand E, Lhermusier T, Morelle JF, Delepine S, Souteyrand G, Ghostine S, Van Belle E, Barthelemy O, Akodad M, Cayla G, Chamandi C, Chemouni F, Parienti JJ, Bouleti C, Eltchaninoff H; SOLOTAVI Investigators. Rationale for Early Discontinuation of Aspirin After Transcatheter Aortic Valve Implantation: Design of the SOLOTAVI Randomized Trial. Am Heart J. 2026 Oct 28:107634. doi: 10.1016/j.ahj.2026.107634. Online ahead of print.
- Individual participant dataSharing planned: No. IPD sharing may be considered if authorised by PI and promoter
Related trials for Transcatheter Aortic Valve Replacement
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Recruiting
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
Aortic Valve Disease, Conduction Disturbances
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin in people with Transcatheter Aortic Valve Replacement, run by University Hospital, Caen at 1 site in France.
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 9 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farzin Beygui, MD,PhD (+33231063350, beygui-f@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net clinical benefit (time frame: 12 months after randomisation). 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 NCT06518317, which also lists 1 linked publication.
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 26 Mar 2025.