Stenoses, AorticSAFARINCT05983458
SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients
A study testing Transaortic valve replacement in people with Stenoses, Aortic, run by Maria Cecilia Hospital at 1 site in Italy.
Trial summary
Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by complications and costs, with a large disparity between clinical trials and real-world scenarios… Read more about this study
- Who is it for?
- Ages 18 to 83 years
- Conditions the study is for
- Stenoses, Aortic
- What is being tested?
- Transaortic valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 26 Sep 2022to Dec 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 18 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 and =< 83 years
- Normal PR interval at 12-lead electrocardiogram (ECG)
- No evidence of Right bundle branch block (RBBB) or high-degree Atrioventricular Block ( AV) blocks at 12-lead ECG
- eGFR > 50 ml/min/1.73 m2
- Ilio-femoral anatomy compatible with transfemoral transcatheter aortic valve implantation (TAVI)
Who cannot join
- Inability to provide informed consent
- Not suitable anatomy for transfemoral access
- Need for general anaesthesia (e.g. hemodynamic instability)
- Bicuspid aortic valve anatomy
- Severely impaired left ventricular ejection fraction (LVEF <35%)
- At least moderate mitral regurgitation
- Non-cardiac illness with a life expectancy of less than 1 year
- Currently participating in another trial before reaching first endpoint.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Maria Cecilia Hospital
Cotignola, Ravenna, 48033
Roberto Nerla, MD, 0545/217446 ext. +39, rnerla@gvmnet.it
About this study
Official title: Safe and Fast Discharge With Acurate Valve in Low Risk Tavi Patients
Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by complications and costs, with a large disparity between clinical trials and real-world scenarios suggesting still long hospitalizations after TAVI. This issue has got relevant implications in cost-effectiveness of the procedure, with many studies showing a more favourable cost profile associated with early discharges
Read the detailed description
In most cases, prolongation of hospital stay is mainly related to electrical, renal, vascular or neurological complications. With increasing operators' experience, careful procedure planning and technology improvement, procedure-related complications are reducing, with favourable effects in terms of postprocedural length-of-stay and related costs.
This is particularly true for lower risk populations. Being surgery the gold standard for treating aortic valve disease in low-risk patients, the outcomes after TAVI in this population should meet high standards to be accepted. In particular, optimal results should not be limited to procedural success but last over time, ensuring both a long-life expectancy and a good quality of life. TAVI efficacy in this population should include the absence of residual paravalvular leaks, no need for permanent pacemakers, no cerebral embolism and the opportunity of easily re-accessing coronary arteries in the future. In particular, many questions have been raised about the difficulty of coronary re-access following use of the EvolutR/PRO valves compared to the Sapien 3 valves. Thus, valves with a larger open-celled design (ACURATE neo, Portico or JENA) are potentially more favourable for coronary access and could be considered in patients likely to require repeated re-access to coronary arteries.
Acurate Neo Valve showed good procedural results in high-risk subsets of patients. Although not tested in large-scale trials involving low risk patients, due to its unique morphology it could offer peculiar advantages, compared to other devices, including:
- Low permanent pacemaker rates
- Easier coronary re-access
- Low paravalvular leak rate (novel Neo 2 technology) The aim of this study was to report on the feasibility and safety of early discharge (defined as discharge within 48 hours from the procedure) of selected low-risk patients after transfemoral TAVI with the novel Acurate Neo2 valve platform
- Conditions
- Stenoses, Aortic
- Being tested
- Transaortic valve replacement
- 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.
Transaortic valve replacementProcedure or surgery
TAVI procedure will be performed under conscious sedation. Foley urinary catheters and jugular lines will be avoided.
For femoral access, closure devices will be Prostar or ProGlide, which are similar and carry low rates of major vascular complications . Single femoral access and a radial access as the secondary arterial access will be used to reduce the rate of vascular complications.
All procedures will be performed with cerebral protection using the Sentinel device. During valve implantation, commissural alignment will be checked for all patients. As a practical rule, commissural alignment will be checked in co-planar view and in cusp-overlap view.
| Study group | Role | What they receive |
|---|---|---|
| patients with severe symptomatic aortic stenosis | Other | Real-world patients with severe symptomatic aortic stenosis allocated to TAVI treatment by local heart Team will be included in the study according to the inclusion and exclusion criteria specified below. Receives: Procedure: Transaortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and efficacy of a standardized rapid discharge protocol in low-risk patients treated with the TAVI procedure and the Acurate Neo 2 valve
Primary Endpoints Composite endpoints (VARC 3)
Introduction of the composite endpoint of technical success defined at exit from procedure room with:
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, Expansion of device success composite endpoint at 30 days defined as: 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) Clinical Efficacy composite endpoint now at 1 year and beyond instead of 30 days
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 posted9 Aug 2023
- Study start26 Sep 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenoses, AorticStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Nerla, MD, Principal investigator, Maria Cecilia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983458
- Sponsor's protocol ID
- SAFARI
- Acronym
- SAFARI
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe and Fast Discharge With Acurate Valve in Low Risk Tavi Patients
- ClinicalTrials.gov ID
- NCT05983458
- Acronym / sponsor ID
- SAFARI / SAFARI
- Conditions
- Stenoses, Aortic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 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.
Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by complications and costs, with a large disparity between clinical trials and real-world scenarios suggesting still long hospitalizations after TAVI. This issue has got relevant implications in cost-effectiveness of the procedure, with many studies showing a more favourable cost profile associated with early discharges
Detailed description
In most cases, prolongation of hospital stay is mainly related to electrical, renal, vascular or neurological complications. With increasing operators' experience, careful procedure planning and technology improvement, procedure-related complications are reducing, with favourable effects in terms of postprocedural length-of-stay and related costs.
This is particularly true for lower risk populations. Being surgery the gold standard for treating aortic valve disease in low-risk patients, the outcomes after TAVI in this population should meet high standards to be accepted. In particular, optimal results should not be limited to procedural success but last over time, ensuring both a long-life expectancy and a good quality of life. TAVI efficacy in this population should include the absence of residual paravalvular leaks, no need for permanent pacemakers, no cerebral embolism and the opportunity of easily re-accessing coronary arteries in the future. In particular, many questions have been raised about the difficulty of coronary re-access following use of the EvolutR/PRO valves compared to the Sapien 3 valves. Thus, valves with a larger open-celled design (ACURATE neo, Portico or JENA) are potentially more favourable for coronary access and could be considered in patients likely to require repeated re-access to coronary arteries.
Acurate Neo Valve showed good procedural results in high-risk subsets of patients. Although not tested in large-scale trials involving low risk patients, due to its unique morphology it could offer peculiar advantages, compared to other devices, including:
- Low permanent pacemaker rates
- Easier coronary re-access
- Low paravalvular leak rate (novel Neo 2 technology) The aim of this study was to report on the feasibility and safety of early discharge (defined as discharge within 48 hours from the procedure) of selected low-risk patients after transfemoral TAVI with the novel Acurate Neo2 valve platform
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with severe symptomatic aortic stenosis | Other | Procedure: Transaortic valve replacementReal-world patients with severe symptomatic aortic stenosis allocated to TAVI treatment by local heart Team will be included in the study according to the inclusion and exclusion criteria specified below. |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=18 and =< 83 years
- Normal PR interval at 12-lead electrocardiogram (ECG)
- No evidence of Right bundle branch block (RBBB) or high-degree Atrioventricular Block ( AV) blocks at 12-lead ECG
- eGFR > 50 ml/min/1.73 m2
- Ilio-femoral anatomy compatible with transfemoral transcatheter aortic valve implantation (TAVI)
Key exclusion criteria (8 listed)
- Inability to provide informed consent
- Not suitable anatomy for transfemoral access
- Need for general anaesthesia (e.g. hemodynamic instability)
- Bicuspid aortic valve anatomy
- Severely impaired left ventricular ejection fraction (LVEF <35%)
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 |
|---|---|---|
| Transaortic valve replacementTAVI procedure will be performed under conscious sedation. Foley urinary catheters and jugular lines will be avoided. For femoral access, closure devices will be Prostar or ProGlide, which are similar and carry low rates of major vascular complications . Single femoral access and a radial access as the secondary arterial access will be used to reduce the rate of vascular complications. All procedures will be performed with cerebral protection using the Sentinel device. During valve implantation, commissural alignment will be checked for all patients. As a practical rule, commissural alignment will be checked in co-planar view and in cusp-overlap view. | Procedure or surgery | patients with severe symptomatic aortic stenosis |
Primary outcome
safety and efficacy of a standardized rapid discharge protocol in low-risk patients treated with the TAVI procedure and the Acurate Neo 2 valve
Time frame: 12 months
Primary Endpoints Composite endpoints (VARC 3) Introduction of the composite endpoint of technical success defined at exit from procedure room with: 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, Expansion of device success composite endpoint at 30 days defined as: 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) Clinical Efficacy composite endpoint now at 1 year and beyond instead of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Roberto Nerla, MD principal investigator
Maria Cecilia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transaortic valve replacement in people with Stenoses, Aortic, run by Maria Cecilia Hospital at 1 site in Italy.
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 8 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 19 Sep 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Nerla, MD (0545/217446 ext. +39, rnerla@gvmnet.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and efficacy of a standardized rapid discharge protocol in low-risk patients treated with the TAVI procedure and the Acurate Neo 2 valve (time frame: 12 months). 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 19 Sep 2024.