Pure Aortic RegurgitationS3ARNCT04671758
Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation
An observational study of Pure Aortic Regurgitation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The hypothesis is that TAVI using a SAPIEN 3 THV is feasible and safe for the treatment of pure AR. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pure Aortic Regurgitation
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 30 Mar 2022
- Phase
- Observational
- 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
Study population: Patients with symptomatic (at least dyspnoea NYHA class III or acute heart failure requiring hospitalisation) and pure AR
Who may be able to join
- Patients with symptomatic (at least dyspnoea NYHA class III or acute heart failure requiring hospitalisation) and pure AR
- Contraindication or high risk for surgical aortic valve replacement
- Echocardiography and computed tomography findings suitable for TAVI using a SAPIEN 3 THV
Who cannot join
- Contraindication for TAVI (active endocarditis, aortic dissection, annuloectasia..)
- Patients' refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Bichat Claude Bernard
Paris, Île-de-France Region, 75018
Dominique Himbert, MD, 33 1 40 25 66 01, dominique.himbert@aphp.fr
Marina Urena, MD, 33 1 40 25 66 01, marina.urena-alcazar@aphp.fr
About this study
Official title: Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation. The S3AR Study TAVI With Sapien 3 for Pure AR.
The hypothesis is that TAVI using a SAPIEN 3 THV is feasible and safe for the treatment of pure AR.
Read the detailed description
Up to now, the balloon-expandable valves have been considered contraindicated for patients with pure AR due to the absence of calcium which is considered necessary for the anchoring of the prosthesis. Nonetheless, several cases report have suggested the feasibility of TAVI using the SAPIEN XT THV, in patients with no calcified valves suggesting that an appropriate degree of oversizing might compensate the lack of calcium for the anchoring of these prostheses.
The new generation balloon-expandable SAPIEN 3 THV has incorporated changes in the stent frame geometry, leaflets configuration and an external sealing skirt resulting in an increased stability and outstanding control during its implantation, a greater radial force, a reduced rate of paravalvular leaks and a covering of a wider range of annulus dimensions. These characteristics of the SAPIEN 3 THV might translate into a safer use of this device in patients with pure AR and non-calcified valves.
Significant AR occurs in 2.0% of individuals of >75 years, 13.3% of patients referred for intervention, being severe in 5% of these patients. As for aortic stenosis, its prevalence increases with age and the most frequent cause is degenerative although rheumatic and endocarditis are present. Although patients with severe AR have an excess risk of mortality and aortic valve replacement reduces mortality, only 1/3 of patients with significant AR finally undergo intervention. Reasons for no intervention are unknown.
Even if it has been suggested that AR might be underestimated and the prevalence of this disease might be higher than previously reported, and a percent of patients with indication for aortic valve replacement are denied for surgery, pure AR is a small niche of patients for TAVI. In terms of cost-effectiveness, both the development of a dedicated device and the investment in the training of operators in the implantation technique might lack of interest. However, performing TAVI with a device used in the routine practice might be appealing and, importantly, safer. A preliminary case series including 3 patients have suggested the feasibility of TAVI with the SAPIEN 3 device for pure AR (Urena M, Himbert D. JACC, 2016 ). In this study we aim to evaluate the feasibility and long-term safety of the SAPIEN 3 THV in patients with pure AR.
- Conditions
- Pure Aortic Regurgitation
- Keywords
- pure AR, TAVI, Sapien 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AR TAVI | The population consists in patients with severe symptomatic AR on native aortic valve who are candidates for surgical aortic valve replacement but who are deemed inoperable by the heart team due to technical issues (i.e., porcelain aorta, previous coronary artery bypass grafting,…), extreme left ventricular dysfunction or comorbidities (liver cirrhosis, severe chronic obstructive pulmonary disease…). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and 30-day safety of TAVI with the SAPIEN 3 THV in patients with pure AR
1/ Device success at 1 month follow up according to the Valve Academic Research Consortium (VARC)-2. 2-Rate of moderate or severe AR at 1-month follow-up
Measured: 30 days
Secondary outcomes (3)
Long-term safety of TAVI with the SAPIEN 3 THV in patients with pure AR
Long-term safety defined as lack of valve migration and 1 year cardiovascular mortality defined according to the VARC-2 (combined endpoint)
Measured: 1 year
Long-term performance of TAVI with the SAPIEN 3 THV in patients with pure AR
Rate of moderate or severe AR at 1-year follow-up
Measured: 1 year
Long-term safety of TAVI with the SAPIEN 3 THV in patients with pure AR
Long-term safety defined as lack of 1-year all cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jun 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Mar 2022 (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 Pure Aortic RegurgitationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Himbert, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671758
- Sponsor's protocol ID
- NI7005J
- Acronym
- S3AR
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Urena M, Himbert D, Ohlmann P, Capretti G, Goublaire C, Kindo M, Morel O, Ghodbane W, Iung B, Vahanian A. Transcatheter Aortic Valve Replacement to Treat Pure Aortic Regurgitation on Noncalcified Native Valves. J Am Coll Cardiol. 2016 Oct 11;68(15):1705-1706. doi: 10.1016/j.jacc.2016.07.746. No abstract available.
PubMed 27712786
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation. The S3AR Study TAVI With Sapien 3 for Pure AR.
- ClinicalTrials.gov ID
- NCT04671758
- Acronym / sponsor ID
- S3AR / NI7005J
- Conditions
- Pure Aortic Regurgitation
- Keywords
- pure AR, TAVI, Sapien 3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 17 Dec 2020 (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 hypothesis is that TAVI using a SAPIEN 3 THV is feasible and safe for the treatment of pure AR.
Detailed description
Up to now, the balloon-expandable valves have been considered contraindicated for patients with pure AR due to the absence of calcium which is considered necessary for the anchoring of the prosthesis. Nonetheless, several cases report have suggested the feasibility of TAVI using the SAPIEN XT THV, in patients with no calcified valves suggesting that an appropriate degree of oversizing might compensate the lack of calcium for the anchoring of these prostheses.
The new generation balloon-expandable SAPIEN 3 THV has incorporated changes in the stent frame geometry, leaflets configuration and an external sealing skirt resulting in an increased stability and outstanding control during its implantation, a greater radial force, a reduced rate of paravalvular leaks and a covering of a wider range of annulus dimensions. These characteristics of the SAPIEN 3 THV might translate into a safer use of this device in patients with pure AR and non-calcified valves.
Significant AR occurs in 2.0% of individuals of >75 years, 13.3% of patients referred for intervention, being severe in 5% of these patients. As for aortic stenosis, its prevalence increases with age and the most frequent cause is degenerative although rheumatic and endocarditis are present. Although patients with severe AR have an excess risk of mortality and aortic valve replacement reduces mortality, only 1/3 of patients with significant AR finally undergo intervention. Reasons for no intervention are unknown.
Even if it has been suggested that AR might be underestimated and the prevalence of this disease might be higher than previously reported, and a percent of patients with indication for aortic valve replacement are denied for surgery, pure AR is a small niche of patients for TAVI. In terms of cost-effectiveness, both the development of a dedicated device and the investment in the training of operators in the implantation technique might lack of interest. However, performing TAVI with a device used in the routine practice might be appealing and, importantly, safer. A preliminary case series including 3 patients have suggested the feasibility of TAVI with the SAPIEN 3 device for pure AR (Urena M, Himbert D. JACC, 2016 ). In this study we aim to evaluate the feasibility and long-term safety of the SAPIEN 3 THV in patients with pure AR.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AR TAVI | – | –The population consists in patients with severe symptomatic AR on native aortic valve who are candidates for surgical aortic valve replacement but who are deemed inoperable by the heart team due to technical issues (i.e., porcelain aorta, previous coronary artery bypass grafting,…), extreme left ventricular dysfunction or comorbidities (liver cirrhosis, severe chronic obstructive pulmonary disease…). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptomatic (at least dyspnoea NYHA class III or acute heart failure requiring hospitalisation) and pure AR
Key inclusion criteria (3 listed)
- Patients with symptomatic (at least dyspnoea NYHA class III or acute heart failure requiring hospitalisation) and pure AR
- Contraindication or high risk for surgical aortic valve replacement
- Echocardiography and computed tomography findings suitable for TAVI using a SAPIEN 3 THV
Key exclusion criteria (2 listed)
- Contraindication for TAVI (active endocarditis, aortic dissection, annuloectasia..)
- Patients' refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility and 30-day safety of TAVI with the SAPIEN 3 THV in patients with pure AR
Time frame: 30 days
1/ Device success at 1 month follow up according to the Valve Academic Research Consortium (VARC)-2. 2-Rate of moderate or severe AR at 1-month follow-up
3 secondary outcomes
Long-term safety of TAVI with the SAPIEN 3 THV in patients with pure AR
Time frame: 1 year
Long-term performance of TAVI with the SAPIEN 3 THV in patients with pure AR
Time frame: 1 year
Long-term safety of TAVI with the SAPIEN 3 THV in patients with pure AR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Background: PubMed 27712786Urena M, Himbert D, Ohlmann P, Capretti G, Goublaire C, Kindo M, Morel O, Ghodbane W, Iung B, Vahanian A. Transcatheter Aortic Valve Replacement to Treat Pure Aortic Regurgitation on Noncalcified Native Valves. J Am Coll Cardiol. 2016 Oct 11;68(15):1705-1706. doi: 10.1016/j.jacc.2016.07.746. No abstract available.
- 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.
Dominique Himbert, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pure Aortic Regurgitation, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 2 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 17 Dec 2020. 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.
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 Dominique Himbert, MD (33140256601, dominique.himbert@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and 30-day safety of TAVI with the SAPIEN 3 THV in patients with pure AR (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 NCT04671758, 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 17 Dec 2020.