Aortic Stenosis, SevereNCT05989074
All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
A study testing ALLEGRA TAVI System TF and Ballon-expandable valve system in people with Aortic Stenosis, Severe, run by Ceric Sàrl.
Trial summary
Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis Read more about this study
- Who is it for?
- Ages 75 years and older, women only
- Conditions the study is for
- Aortic Stenosis, Severe
- What is being tested?
- ALLEGRA TAVI System TF and Ballon-expandable valve system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Aug 2025
- 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
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Female sex
- Age ≥ 75 years (according to ESC/EACTS, Guidelines for the management of valvular heart disease)
- Severe calcific aortic valve stenosis defined as follows: high-gradient aortic stenosis (mean pressure gradient across aortic valve > 40 mmHg or peak velocity > 4.0 m/s) Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Class ≥II
- ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus perimeter-derived average diameter >19 mm and <27.4 mm or area-derived diameter >18 and <28 mm
- Anatomy suitable for trans-femoral TAVI for both devices used in the study, including a minimum femoral diameter of 6 mm.
- Subject with a documented local Heart Team (HT) indication for TF TAVI
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- Life expectancy longer than 1 year.
- Willingness to undergo clinical and echocardiographic follow-up after the procedure.
- Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow-up requirements
Who cannot join
- Male sex
- Non-calcific acquired aortic stenosis
- Native unicuspid/bicuspid aortic valve or congenital aortic abnormality
- Previous implantation of heart valve in any position
- Severe aortic regurgitation (> 3+)
- Severe mitral regurgitation (> 3+)
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- Severe tricuspid regurgitation (> 3+)
- Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) < 30%)
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Untreated cardiac conduction disease in need of pacemaker implantation
- Evidence of acute Myocardial Infarction (MI) less than 30 days before signing informed consent
- Any need for emergency surgery
- Any active bleeding that precludes anticoagulation
- Liver failure (Child-C)
- End-stage renal disease requiring chronic dialysis or creatinine clearance < 30cc/min
- Pulmonary hypertension (systolic pressure > 80mmHg)
- A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), to cobalt chromium, to bovine and/or collagen, glutaraldehyde or contrast media
- Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow-up procedures
- Currently participating in another drug or device trial (excluding observational registries) for which the primary endpoint has not been assessed
- Subject under judicial protection, tutorship or curatorship (for France only)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: All Women A Multicenter Randomized Clinical Trial Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve in a Women Population
Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis
Read the detailed description
Study is aimed to demonstrate that the self-expandable Allegra transcatheter aortic valve implantation (TAVI) system provides lower mean gradient assessed by Transthoracic Echo (TTE) at 30 days post procedure, compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis.
Patients in both arm will receive anticoagulants according to routine practice of the hospital.
Patients will be followed-up until 1 year after the procedure.
- Conditions
- Aortic Stenosis, Severe
- Being tested
- ALLEGRA TAVI System TF, Ballon-expandable valve system
- 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.
ALLEGRA TAVI System TFDevice
Patients receive ALLEGRA TAVI System TF. Patient will receive medication according to routine practice of the hospital
Ballon-expandable valve systemDevice
Patients receive any kind of CE-marked balloon expandable valve system, used at the hospital. Patient will receive medication according to routine practice of the hospital.
| Study group | Role | What they receive |
|---|---|---|
| ALLEGRA | Experimental | ALLEGRA Delivery System TF will be administered.Patient will receive Anticoagulation medication according to the site-specific standard of care Receives: Device: ALLEGRA TAVI System TF |
| Balloon-expandable TAVI | Active comparator | Patient will receive any kind of CE-marked balloon-expandable valve, and anticoagulation medication according to the site-specific standard of care Receives: Device: Ballon-expandable valve system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
Measured: At 30 Days
Secondary outcomes (4)
Technical success assessed by composite criteria
- Freedom from mortality
- 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 or to a major vascular or access-related, or cardiac structural complication
Measured: Up to the end of the time when patient exit the procedure room
Device success assessed by composite criteria
Technical success
- Freedom from mortality
- Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
- Intended performance of the valve‡ (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)
Measured: At 30 days
Early safety assessed by composite criteria
- Freedom from all-cause mortality
- Freedom from all stroke
- Freedom from Valve Academic Research Consortium (VARC) type 2-4 bleeding (in trials where control group is surgery, it is appropriate to include only Type 3 and 4 bleeding)
- Freedom from major vascular, access-related, or cardiac structural complication
- Freedom from acute kidney injury stage 3 or 4
- Freedom from moderate or severe aortic regurgitation
- Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
- Freedom from surgery or intervention related to the device
Measured: At 30 days
Clinical efficacy assessed by composite criteria
- Freedom from all-cause mortality
- Freedom from all stroke
- Freedom from hospitalization for procedure- or valve-related causes
- Freedom from Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score <45 or decline from baseline of >10 point (i.e. Unfavourable Outcome)
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Feb 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis, SevereStudies of the same condition, open and under way.
- More trials run by Ceric SàrlThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biosensors International, European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Alaide Chieffo, Prof, Principal investigator, Ospedale San RaffaeleIgnacio Cruz-Gonzalez, Prof, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989074
- Sponsor's protocol ID
- BSR-14
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All Women A Multicenter Randomized Clinical Trial Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve in a Women Population
- ClinicalTrials.gov ID
- NCT05989074
- Acronym / sponsor ID
- BSR-14
- Conditions
- Aortic Stenosis, Severe
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ceric SàrlIndustry (pharma, biotech, devices)
- Collaborators
- Biosensors International, European Cardiovascular Research Center
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis
Detailed description
Study is aimed to demonstrate that the self-expandable Allegra transcatheter aortic valve implantation (TAVI) system provides lower mean gradient assessed by Transthoracic Echo (TTE) at 30 days post procedure, compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis.
Patients in both arm will receive anticoagulants according to routine practice of the hospital.
Patients will be followed-up until 1 year after the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLEGRA | Experimental | Device: ALLEGRA TAVI System TFALLEGRA Delivery System TF will be administered.Patient will receive Anticoagulation medication according to the site-specific standard of care |
| Balloon-expandable TAVI | Active comparator | Device: Ballon-expandable valve systemPatient will receive any kind of CE-marked balloon-expandable valve, and anticoagulation medication according to the site-specific standard of care |
Who may qualify
- Ages
- 75 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Female sex
- Age ≥ 75 years (according to ESC/EACTS, Guidelines for the management of valvular heart disease)
- Severe calcific aortic valve stenosis defined as follows: high-gradient aortic stenosis (mean pressure gradient across aortic valve > 40 mmHg or peak velocity > 4.0 m/s) Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Class ≥II
- ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus perimeter-derived average diameter >19 mm and <27.4 mm or area-derived diameter >18 and <28 mm
- Anatomy suitable for trans-femoral TAVI for both devices used in the study, including a minimum femoral diameter of 6 mm.
Key exclusion criteria (20 listed)
- Male sex
- Non-calcific acquired aortic stenosis
- Native unicuspid/bicuspid aortic valve or congenital aortic abnormality
- Previous implantation of heart valve in any position
- Severe aortic regurgitation (> 3+)
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 |
|---|---|---|
| ALLEGRA TAVI System TFPatients receive ALLEGRA TAVI System TF. Patient will receive medication according to routine practice of the hospital | Device | ALLEGRA |
| Ballon-expandable valve systemPatients receive any kind of CE-marked balloon expandable valve system, used at the hospital. Patient will receive medication according to routine practice of the hospital. | Device | Balloon-expandable TAVI |
Primary outcome
Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
Time frame: At 30 Days
Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
4 secondary outcomes
Technical success assessed by composite criteria
Time frame: Up to the end of the time when patient exit the procedure room
Device success assessed by composite criteria
Time frame: At 30 days
Early safety assessed by composite criteria
Time frame: At 30 days
Clinical efficacy assessed by composite criteria
Time frame: At 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- 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.
Alaide Chieffo, Prof principal investigator
Ospedale San Raffaele
Ignacio Cruz-Gonzalez, Prof principal investigator
University of Salamanca
Questions about this trial
What is this clinical trial studying?
A study testing ALLEGRA TAVI System TF and Ballon-expandable valve system in people with Aortic Stenosis, Severe, run by Ceric Sàrl.
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 20 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 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Nozomi Watanabe (+33 (0)6 61 38 94 80, nwatanabe@cerc-europe.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure. (time frame: At 30 Days). 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 12 Jan 2024.