Severe Aortic Valve StenosisBSC07NCT05847751
The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
An observational study of Severe Aortic Valve Stenosis, run by Ceric Sàrl at 7 sites in 3 countries.
Trial summary
The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Aortic Valve Stenosis
- What is being tested?
- Aortic valve replacement
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 6 Mar 2024to Jul 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 100 patients from Middle East population with severe, symptomatic aortic stenosis will be enrolled
Who may be able to join
- Subject will be included if all of the following criteria are met:
- Patient with severe aortic stenosis defined by an aortic valve area (AVA) < 1cm2 or AVA indexed to body surface area (BSA) of < 0.6 cm2/m2, including low-flow severe aortic stenosis defined by stroke volume index (SVI) < 35ml/m2, as assessed by integration of echocardiographic and invasive measurements
- Subject is symptomatic (heart failure symptoms with New York Heart Association (NYHA) Functional Class > I, angina or syncope)
- Patient is considered at high (STS-PROM (Society of Thoracic Surgeons-Predicted Risk of Mortality) score >8) or intermediate (STS-PROM score >4) risk by the Heart Team.
- The heart team agrees on eligibility of the patient for participation and that TAVR (Transcatheter aortic valve replacement) (TAVR) by transfemoral access constitutes the most appropriate treatment modality, from which the patient will likely benefit most
- Aortic annulus dimensions suitable (area range: 338-573 mm2 AND perimeter range: 66-85 mm) based on ECG-gated multislice computed tomographic measurements. Findings of transesophageal echocardiography (TEE) and conventional aortography should be integrated in the anatomic assessment if available
Show all 9Show fewer
- Arterial aorto-iliac-femoral axis suitable for transfemoral access with a minimum access vessel diameter ≥ 6 mm as assessed by multislice computed tomographic angiography and/or conventional angiography
- Written informed consent of the patient or her/his legal representative
- Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up
Who cannot join
- Subject will not be included if any one of the following conditions exists:
- Non-valvular aortic stenosis
- Congenital aortic stenosis or unicuspid or bicuspid aortic valve
- Non-calcific acquired aortic stenosis
- Anatomy not appropriate for transfemoral transcatheter aortic valve implantation due to size of the aortic annulus or degree or eccentricity of calcification of the native aortic valve or tortuosity of the aorta or ilio-femoral arteries
- Emergency procedure including patients in cardiogenic shock (low cardiac output, vasopressor dependence, mechanical hemodynamic support)
Show all 20Show fewer
- Severely reduced left ventricular (LV) function (ejection fraction < 20%)
- Pre-existing prosthetic heart valve in aortic position
- Presence of mitral valve prosthesis
- Concomitant planned procedure except for percutaneous coronary intervention (PCI)
- Planned non-cardiac surgery within 30 days
- Stroke within 30 days of the procedure.
- Myocardial infarction within 30 days of the procedure (except type 2)
- Evidence of intra-cardiac mass, thrombus or vegetation
- Severe coagulation conditions
- Inability to tolerate anticoagulation/anti-platelet therapy
- Active bacterial endocarditis or other active infections
- Hypertrophic cardiomyopathy
- Contraindication to contrast media or allergy to nitinol
- Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Egypt3 sites
Magdy Yacoub heart center
Aswān
Ain shams Specialized hospital
Cairo
Badr hospital
Cairo
Saudi Arabia3 sites
King Fahad Armed Forces Hospital
Jeddah
King Fahad National Guard Hospital
Riyadh
National Guard Hospital - King Abdulaziz Medical City
Riyadh
About this study
The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.
Read the detailed description
The MENA-TAVI study is an investigator-initiated, prospective, single-arm observational trial.
Patients referred for or presenting with severe aortic stenosis requiring an intervention constitute the source population. The Heart Team consisting of interventional cardiologists and cardiovascular surgeons will evaluate the patients by integrating the available clinical data, the predicted 30-day mortality, individual factors affecting mortality such as frailty as well as the estimated life-expectancy and the patient's wishes to finally reach a consensus on the optimal treatment strategy with regards to transcatheter or surgical aortic valve replacement. Patients planned for TAVI will be screened for eligibility. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. In case of consent, they will be treated by the ACURATE neo2 aortic bioprosthesis.
At discharge and at 30 days, the clinical outcomes composing the primary safety endpoint will be captured. Additional clinical, procedural and echocardiographic data will be obtained at discharge and at 30 days for assessment of secondary endpoints.
- Conditions
- Severe Aortic Valve Stenosis
- Being tested
- Aortic 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.
Aortic valve replacementDevice
Trans Aortic Valve Replacement (TAVI)
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
All deaths reported
Measured: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
Any stroke (disabling and non-disabling)
All stroke events
Measured: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
Secondary outcomes (14)
Technical success as defined by VARC-3
Combined endpoint composed of:
- 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: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
Device success as defined by VARC-3
Combined endpoint composed of:
- 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 <20mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation)
Measured: Post-procedure discharge of patient from the hospital and at 30 days follow up
Early safety as defined by VARC-3
Combined endpoint composed of:
- Freedom from all-cause mortality
- Freedom from all stroke
- Freedom from VARC 3 type 2-4 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
Modified combined early safety and clinical efficacy at 30 days as defined by the Valve Academic research Consortium (VARC-2)
- All cause death)
- All stroke (disabling and non-disabling)
- Acute kidney injury (Stage 1 or 2, including renal replacement therapy)
- Coronary artery obstruction requiring intervention
- Major vascular complication
- Valve related dysfunction requiring repeat procedure
- Re-hospitalization for valve related symptoms or worsening congestive heart failure
- Valve related dysfunction
- Prosthetic aorta valve stenosis: mean aortic valve gradient >= 20 mmHg, effective orifice area (EOL) <= 1.1 cm2 (if body surface area >=1.6 m2) or <= 0.9 cm2 if BSA <1.6 m2 and/or Doppler velocity index <0.35
- Moderate or severe prosthetic valve regurgitation according to VARC-2
Measured: At 30 days
Clinical efficacy as defined by VARC-3
Combined endpoint composed of:
- Freedom from all-cause mortality
- Freedom from all stroke
- Freedom from hospitalization for procedure- or valve-related causes
Combined endpoint composed of:
- Freedom from all-cause mortality
- Freedom from all stroke
- Freedom from hospitalization for procedure- or valve-related causes
Measured: At 30 days
All-cause mortality
All deaths reported
Measured: At 30 days
Valve-related mortality
All deaths related to valve
Measured: At 30 days
All stroke (ischaemic, haemorrhagic)
All stroke reported
Measured: At 30 days
Hospitalization (or re-hospitalization)
All hospitalization reported
Measured: At 30 days
Bleeding and transfusions (VARC3 type 1 - 4)
All bleeding events reported
Measured: At 30 days
Bioprosthetic valve dysfunction
(structural, non structural, thrombosis, endocarditis): (Stage 1 to 3)
Measured: At 30 days
Clinically significant prosthetic valve thrombosis
Valve related thrombosis
Measured: At 30 days
Implantation of permanent pacemaker
Pacemaker implantation
Measured: At 30 days
Occurrence of atrial fibrilation
atrial fbrillation reported
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start6 Mar 2024
- Primary completion31 May 2026
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (77)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic Valve 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Mohamed BALGHITH, MD, Principal investigator, King Fahad National Guard Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847751
- Sponsor's protocol ID
- MENA TAVI
- Acronym
- BSC07
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
PubMed 12831818Otto CM, Prendergast B. Aortic-valve stenosis--from patients at risk to severe valve obstruction. N Engl J Med. 2014 Aug 21;371(8):744-56. doi: 10.1056/NEJMra1313875. No abstract available.
PubMed 25140960Tibazarwa KB, Volmink JA, Mayosi BM. Incidence of acute rheumatic fever in the world: a systematic review of population-based studies. Heart. 2008 Dec;94(12):1534-40. doi: 10.1136/hrt.2007.141309. Epub 2008 Jul 31.
PubMed 18669552Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9.
PubMed 22405798Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7. doi: 10.1056/NEJM199907153410302.
PubMed 10403851Otto CM. Calcific aortic stenosis--time to look more closely at the valve. N Engl J Med. 2008 Sep 25;359(13):1395-8. doi: 10.1056/NEJMe0807001. No abstract available.
PubMed 18815402Thanassoulis G, Campbell CY, Owens DS, Smith JG, Smith AV, Peloso GM, Kerr KF, Pechlivanis S, Budoff MJ, Harris TB, Malhotra R, O'Brien KD, Kamstrup PR, Nordestgaard BG, Tybjaerg-Hansen A, Allison MA, Aspelund T, Criqui MH, Heckbert SR, Hwang SJ, Liu Y, Sjogren M, van der Pals J, Kalsch H, Muhleisen TW, Nothen MM, Cupples LA, Caslake M, Di Angelantonio E, Danesh J, Rotter JI, Sigurdsson S, Wong Q, Erbel R, Kathiresan S, Melander O, Gudnason V, O'Donnell CJ, Post WS; CHARGE Extracoronary Calcium Working Group. Genetic associations with valvular calcification and aortic stenosis. N Engl J Med. 2013 Feb 7;368(6):503-12. doi: 10.1056/NEJMoa1109034.
PubMed 23388002Katz R, Wong ND, Kronmal R, Takasu J, Shavelle DM, Probstfield JL, Bertoni AG, Budoff MJ, O'Brien KD. Features of the metabolic syndrome and diabetes mellitus as predictors of aortic valve calcification in the Multi-Ethnic Study of Atherosclerosis. Circulation. 2006 May 2;113(17):2113-9. doi: 10.1161/CIRCULATIONAHA.105.598086. Epub 2006 Apr 24.
PubMed 16636166Owens DS, Katz R, Takasu J, Kronmal R, Budoff MJ, O'Brien KD. Incidence and progression of aortic valve calcium in the Multi-ethnic Study of Atherosclerosis (MESA). Am J Cardiol. 2010 Mar 1;105(5):701-8. doi: 10.1016/j.amjcard.2009.10.071.
PubMed 20185020Iung B, Vahanian A. Degenerative calcific aortic stenosis: a natural history. Heart. 2012 Nov;98 Suppl 4:iv7-13. doi: 10.1136/heartjnl-2012-302395.
PubMed 23143128Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 May 3;366(18):1696-704. doi: 10.1056/NEJMoa1202277. Epub 2012 Mar 26.
PubMed 22443478Rosenhek R, Zilberszac R, Schemper M, Czerny M, Mundigler G, Graf S, Bergler-Klein J, Grimm M, Gabriel H, Maurer G. Natural history of very severe aortic stenosis. Circulation. 2010 Jan 5;121(1):151-6. doi: 10.1161/CIRCULATIONAHA.109.894170. Epub 2009 Dec 21.
PubMed 20026771Clark MA, Arnold SV, Duhay FG, Thompson AK, Keyes MJ, Svensson LG, Bonow RO, Stockwell BT, Cohen DJ. Five-year clinical and economic outcomes among patients with medically managed severe aortic stenosis: results from a Medicare claims analysis. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):697-704. doi: 10.1161/CIRCOUTCOMES.112.966002. Epub 2012 Sep 4.
PubMed 22949492Braunwald E. On the natural history of severe aortic stenosis. J Am Coll Cardiol. 1990 Apr;15(5):1018-20. doi: 10.1016/0735-1097(90)90235-h. No abstract available.
PubMed 2312955Teo KK, Corsi DJ, Tam JW, Dumesnil JG, Chan KL. Lipid lowering on progression of mild to moderate aortic stenosis: meta-analysis of the randomized placebo-controlled clinical trials on 2344 patients. Can J Cardiol. 2011 Nov-Dec;27(6):800-8. doi: 10.1016/j.cjca.2011.03.012. Epub 2011 Jul 13.
PubMed 21742465
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT05847751
- Acronym / sponsor ID
- BSC07 / MENA TAVI
- Conditions
- Severe Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ceric SàrlIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 May 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.
The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.
Detailed description
The MENA-TAVI study is an investigator-initiated, prospective, single-arm observational trial.
Patients referred for or presenting with severe aortic stenosis requiring an intervention constitute the source population. The Heart Team consisting of interventional cardiologists and cardiovascular surgeons will evaluate the patients by integrating the available clinical data, the predicted 30-day mortality, individual factors affecting mortality such as frailty as well as the estimated life-expectancy and the patient's wishes to finally reach a consensus on the optimal treatment strategy with regards to transcatheter or surgical aortic valve replacement. Patients planned for TAVI will be screened for eligibility. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. In case of consent, they will be treated by the ACURATE neo2 aortic bioprosthesis.
At discharge and at 30 days, the clinical outcomes composing the primary safety endpoint will be captured. Additional clinical, procedural and echocardiographic data will be obtained at discharge and at 30 days for assessment of secondary endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 100 patients from Middle East population with severe, symptomatic aortic stenosis will be enrolled
Key inclusion criteria (9 listed)
- Subject will be included if all of the following criteria are met:
Key exclusion criteria (20 listed)
- Subject will not be included if any one of the following conditions exists:
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 |
|---|---|---|
| Aortic valve replacementTrans Aortic Valve Replacement (TAVI) | Device | – |
Primary outcome
All cause mortality
Time frame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
All deaths reported
Any stroke (disabling and non-disabling)
Time frame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
All stroke events
14 secondary outcomes
Technical success as defined by VARC-3
Time frame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)
Device success as defined by VARC-3
Time frame: Post-procedure discharge of patient from the hospital and at 30 days follow up
Early safety as defined by VARC-3
Time frame: At 30 days
Modified combined early safety and clinical efficacy at 30 days as defined by the Valve Academic research Consortium (VARC-2)
Time frame: At 30 days
Clinical efficacy as defined by VARC-3
Time frame: At 30 days
All-cause mortality
Time frame: At 30 days
Valve-related mortality
Time frame: At 30 days
All stroke (ischaemic, haemorrhagic)
Time frame: At 30 days
Hospitalization (or re-hospitalization)
Time frame: At 30 days
Bleeding and transfusions (VARC3 type 1 - 4)
Time frame: At 30 days
Bioprosthetic valve dysfunction
Time frame: At 30 days
Clinically significant prosthetic valve thrombosis
Time frame: At 30 days
Implantation of permanent pacemaker
Time frame: At 30 days
Occurrence of atrial fibrilation
Time frame: At 30 days
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 23 Jul 2026.
- Background: PubMed 12831818Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
- Background: PubMed 25140960Otto CM, Prendergast B. Aortic-valve stenosis--from patients at risk to severe valve obstruction. N Engl J Med. 2014 Aug 21;371(8):744-56. doi: 10.1056/NEJMra1313875. No abstract available.
- Background: PubMed 18669552Tibazarwa KB, Volmink JA, Mayosi BM. Incidence of acute rheumatic fever in the world: a systematic review of population-based studies. Heart. 2008 Dec;94(12):1534-40. doi: 10.1136/hrt.2007.141309. Epub 2008 Jul 31.
- Background: PubMed 22405798Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9.
- Background: PubMed 10403851Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7. doi: 10.1056/NEJM199907153410302.
- Background: PubMed 18815402Otto CM. Calcific aortic stenosis--time to look more closely at the valve. N Engl J Med. 2008 Sep 25;359(13):1395-8. doi: 10.1056/NEJMe0807001. No abstract available.
- Background: PubMed 23388002Thanassoulis G, Campbell CY, Owens DS, Smith JG, Smith AV, Peloso GM, Kerr KF, Pechlivanis S, Budoff MJ, Harris TB, Malhotra R, O'Brien KD, Kamstrup PR, Nordestgaard BG, Tybjaerg-Hansen A, Allison MA, Aspelund T, Criqui MH, Heckbert SR, Hwang SJ, Liu Y, Sjogren M, van der Pals J, Kalsch H, Muhleisen TW, Nothen MM, Cupples LA, Caslake M, Di Angelantonio E, Danesh J, Rotter JI, Sigurdsson S, Wong Q, Erbel R, Kathiresan S, Melander O, Gudnason V, O'Donnell CJ, Post WS; CHARGE Extracoronary Calcium Working Group. Genetic associations with valvular calcification and aortic stenosis. N Engl J Med. 2013 Feb 7;368(6):503-12. doi: 10.1056/NEJMoa1109034.
- Background: PubMed 16636166Katz R, Wong ND, Kronmal R, Takasu J, Shavelle DM, Probstfield JL, Bertoni AG, Budoff MJ, O'Brien KD. Features of the metabolic syndrome and diabetes mellitus as predictors of aortic valve calcification in the Multi-Ethnic Study of Atherosclerosis. Circulation. 2006 May 2;113(17):2113-9. doi: 10.1161/CIRCULATIONAHA.105.598086. Epub 2006 Apr 24.
- Background: PubMed 20185020Owens DS, Katz R, Takasu J, Kronmal R, Budoff MJ, O'Brien KD. Incidence and progression of aortic valve calcium in the Multi-ethnic Study of Atherosclerosis (MESA). Am J Cardiol. 2010 Mar 1;105(5):701-8. doi: 10.1016/j.amjcard.2009.10.071.
- Background: PubMed 23143128Iung B, Vahanian A. Degenerative calcific aortic stenosis: a natural history. Heart. 2012 Nov;98 Suppl 4:iv7-13. doi: 10.1136/heartjnl-2012-302395.
- Background: PubMed 22443478Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 May 3;366(18):1696-704. doi: 10.1056/NEJMoa1202277. Epub 2012 Mar 26.
- Background: PubMed 20026771Rosenhek R, Zilberszac R, Schemper M, Czerny M, Mundigler G, Graf S, Bergler-Klein J, Grimm M, Gabriel H, Maurer G. Natural history of very severe aortic stenosis. Circulation. 2010 Jan 5;121(1):151-6. doi: 10.1161/CIRCULATIONAHA.109.894170. Epub 2009 Dec 21.
- 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.
Mohamed BALGHITH, MD principal investigator
King Fahad National Guard Hospital
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Valve Stenosis, run by Ceric Sàrl at 7 sites in 3 countries.
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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Egypt, Saudi Arabia, Lebanon. 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?
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?
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?
All cause mortality (time frame: Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure)). 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 NCT05847751, which also lists 77 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 23 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.