Aortic StenosisNOSCAR-TAVINCT07515768
TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol
A study testing transcathter aortic valve implantation in people with Aortic Stenosis, run by Medical University of Warsaw.
Trial summary
Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with symptomatic severe AS. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- transcathter aortic valve implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2030
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Severe degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥40 mmHg or jet velocity ≥4.0 m/s or an aortic valve area (AVA) of ≤1 cm2 (or AVA index <0.6 cm2/m2)
- Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II.
- Suitable for percutaneous transfemoral access
- Age ≥70 years
Who cannot join
- Prior aortic valve replacement
- Bicuspid aortic valve on pre-procedural CT
- Contraindication to femoral access
- Other imaging features indicating increased procedural risk (extremely horizontal aorta, severe aortic root dilatation, aortic annulus outside the range of commercially available devices, high coronary risk occlusion)
- Life expectancy <12 month or active malignancy
- Active endocarditis
About this study
Official title: Transcatheter Aortic Valve Implantation Without On-Site Cardiac Surgery in Poland: Protocol for a Multicenter Prospective Randomized Open-label Clinical Trial
Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with symptomatic severe AS. The latest 2025 ESC guidelines have broadened age-related eligibility, while the procedure still continues to be limited to centres with cardiac surgery on-site (CSOS). This limitation is in place, despite the very low rate of complications requiring emergent surgical conversion. This subsequently, may constrain procedural capacity and contribute to prolonged waiting times, which in turn are associated with increased pre-procedural mortality and heart failure-related hospitalizations. This prospective randomized open-label clinical trial aims to evaluate the safety and feasibility of performing TAVI in selected pilot centers operating without on-site cardiac surgery department (no-CSOS). Selected patients with severe native AS deemed suitable for transfemoral TAVI by a Heart Team will be enrolled. No-CSOS centers must meet predefined criteria, including operators experience, hybrid operating room availability, on-site vascular surgery availability, and established rapid transfer pathways to CSOS centers. The primary endpoint of the study is early 30-day safety based on VARC-3 criteria; secondary endpoints include additional composite outcomes. Patients will be randomly assigned in a 1:1 ratio using a central Web-based system to undergo TAVI either at a CSOS or non-CSOS site. A total of 404 patients (202 per group) is required. The study will inform national strategies and contribute to defining contemporary safety standards for TAVI delivery in no-CSOS centres.
Read the detailed description
The aim of this study is to assess whether TAVI performed in no-CSOS sites achieves clinical outcomes comparable to those achieved in established TAVI centers with surgical backup. Moreover, this study will contribute to updating safety standards for the treatment of aortic stenosis in the context of ongoing advancements in structural heart disease interventions and the increasing clinical demand for timely access to TAVI.
Although TAVI volume in Poland continues to rise - (n=4904 in 2024, increase by 21% compared with 2023) - the national rate of 127 procedures per million inhabitants remains below the European average. Very cautious epidemiological simulations published 8 years ago, in the setting of previous valvular guidelines, suggest that the estimated number of TAVI candidates in Poland is close to 11 000/per year. To that end, the requirement for on-site cardiac surgery substantially restricts access, with only 32 of more than 170 interventional cardiology centers in Poland currently offering TAVI. This limited availability contributes to prolonged waiting times for patients already qualified by the Heart Team, often exceeding six months, which is associated with a markedly increased risk of adverse outcomes related to aortic stenosis. With contemporary transcatheter heart valves offering an excellent safety profile, mortality among patients with AS is now higher during the waiting period for TAVI than after the procedure itself. This underscores the urgent need to expand access to this life-saving procedure by enabling no-CSOS centres to perform TAVI in appropriately selected settings.
Available large-scale registries and observational analyses consistently demonstrate that TAVI performed in no-CSOS centers can achieve clinical outcomes comparable to those of centers with surgical backup. These data indicate that, with appropriate patient selection and structured procedural safeguards, the absence of an on-site cardiac surgery does not adversely affect early or mid-term mortality or complication rates. The incidence of complications requiring emergent cardiac surgery is decreasing and well below 0.5%. However, when such events occur, they are associated with very high mortality (reaching up to 50%), which remains substantial regardless of surgical availability. The present study is unique in terms of conceptualization and methodology as unlike other currently being conducted, while providing maximum procedural safety, it does not limit the AS population to non-operable or highest-risk individuals, and therefore making the results potentially transferable to intermediate and low risk cohorts and subsequently making it more relevant in the light of recent valvular guidelines. Also, the exclusion of more complex aortic and access-site cases, or re-do interventions is in line with the already proven concept tested in coronary interventions field, where only the most complex anatomical cases are recommended to be performed at CSOS sites.
A multicenter Polish registry comparing balloon aortic valvuloplasty in stand-alone catheterization laboratories versus centers with on-site cardiac surgery provided important pilot data supporting the feasibility of interventional treatment for aortic stenosis in settings without surgical backup. Despite treating a higher-risk patient population, standalone laboratories demonstrated no significant differences in major adverse events compared with surgical centers. In-hospital mortality was similar - and even numerically lower in the stand-alone group (0.7% vs 2.9%, p=0.14) - while both settings achieved comparable hemodynamic improvement. Collectively, these findings underscore the safety and practicality of performing selected structural interventions without immediate on-site cardiac surgery.
In conclusion, current evidence indicates that, with adequate patient selection and well-defined procedural safeguards, the absence of on-site cardiac surgery does not preclude the safe and effective performance of TAVI. The findings of this study are expected to provide robust, nationally representative data to inform regulatory decisions and support the development of optimized care pathways that expand equitable access to TAVI.
- Conditions
- Aortic Stenosis
- Being tested
- transcathter aortic valve implantation
- Keywords
- aortic stenosis, transcatceter aortic valve implantation
- 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.
transcathter aortic valve implantationProcedure or surgery
Patients with severe native AS who are adjudicated as suitable candidates for transfemoral TAVI by the Heart Team in CSOS centre will be eligible for inclusion in the study. The choice of the transcatheter heart valve will be at the discrection of the local heart team (all available THV's will be allowed). Major anatomical contraindications to inclusion in the trial will include previous aortic valve implantation, native bicuspid aortic valve morphology and CT-derived imaging characteristics indicative of a high risk of access-site and delivery route complications.
| Study group | Role | What they receive |
|---|---|---|
| TAVI performed at the center with on-site cardiac surgery | Active comparator | standard of care Receives: Procedure: transcathter aortic valve implantation |
| TAVI performed at the center without on-site cardiac surgery | Experimental | Not described Receives: Procedure: transcathter aortic valve implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early safety
absence of: (i) all-cause mortality; (ii) stroke; (iii) VARC type 2-4 bleeding; (iv) major vascular or access-related complications; (v) cardiac structural complications; (vi) acute kidney injury stage 3-4; (vii) moderate or severe aortic regurgitation; (viii) new permanent pacemaker implantation; and (ix) device-related surgery or intervention.
Measured: 30-days
Secondary outcomes (2)
Device success
successful deployment, correct positioning, no urgent surgery
Measured: 30-days
clinical efficacy
freedom from all-cause mortality, all stroke, hospitalization for valve/procedure-related causes, and unfavorable patient-reported quality of life
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 posted7 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kajetan Grodecki, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515768
- Sponsor's protocol ID
- NOSCAR-TAVI
- Acronym
- NOSCAR-TAVI
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: upon reasonable request from third parties
Publications
Praz F, Borger MA, Lanz J, Marin-Cuartas M, Abreu A, Adamo M, Ajmone Marsan N, Barili F, Bonaros N, Cosyns B, De Paulis R, Gamra H, Jahangiri M, Jeppsson A, Klautz RJM, Mores B, Perez-David E, Poss J, Prendergast BD, Rocca B, Rossello X, Suzuki M, Thiele H, Tribouilloy CM, Wojakowski W; ESC/EACTS Scientific Document Group. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025 Nov 21;46(44):4635-4736. doi: 10.1093/eurheartj/ehaf194. No abstract available.
PubMed 40878295Genereux P, Sharma RP, Cubeddu RJ, Aaron L, Abdelfattah OM, Koulogiannis KP, Marcoff L, Naguib M, Kapadia SR, Makkar RR, Thourani VH, van Boxtel BS, Cohen DJ, Dobbles M, Barnhart GR, Kwon M, Pibarot P, Leon MB, Gillam LD. The Mortality Burden of Untreated Aortic Stenosis. J Am Coll Cardiol. 2023 Nov 28;82(22):2101-2109. doi: 10.1016/j.jacc.2023.09.796. Epub 2023 Oct 24.
PubMed 37877909Coffey S, Cairns BJ, Iung B. The modern epidemiology of heart valve disease. Heart. 2016 Jan;102(1):75-85. doi: 10.1136/heartjnl-2014-307020. Epub 2015 Nov 5. No abstract available.
PubMed 26541169
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Implantation Without On-Site Cardiac Surgery in Poland: Protocol for a Multicenter Prospective Randomized Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT07515768
- Acronym / sponsor ID
- NOSCAR-TAVI / NOSCAR-TAVI
- Conditions
- Aortic Stenosis
- Keywords
- aortic stenosis, transcatceter aortic valve implantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 7 Apr 2026 (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.
Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with symptomatic severe AS. The latest 2025 ESC guidelines have broadened age-related eligibility, while the procedure still continues to be limited to centres with cardiac surgery on-site (CSOS). This limitation is in place, despite the very low rate of complications requiring emergent surgical conversion. This subsequently, may constrain procedural capacity and contribute to prolonged waiting times, which in turn are associated with increased pre-procedural mortality and heart failure-related hospitalizations. This prospective randomized open-label clinical trial aims to evaluate the safety and feasibility of performing TAVI in selected pilot centers operating without on-site cardiac surgery department (no-CSOS). Selected patients with severe native AS deemed suitable for transfemoral TAVI by a Heart Team will be enrolled. No-CSOS centers must meet predefined criteria, including operators experience, hybrid operating room availability, on-site vascular surgery availability, and established rapid transfer pathways to CSOS centers. The primary endpoint of the study is early 30-day safety based on VARC-3 criteria; secondary endpoints include additional composite outcomes. Patients will be randomly assigned in a 1:1 ratio using a central Web-based system to undergo TAVI either at a CSOS or non-CSOS site. A total of 404 patients (202 per group) is required. The study will inform national strategies and contribute to defining contemporary safety standards for TAVI delivery in no-CSOS centres.
Detailed description
The aim of this study is to assess whether TAVI performed in no-CSOS sites achieves clinical outcomes comparable to those achieved in established TAVI centers with surgical backup. Moreover, this study will contribute to updating safety standards for the treatment of aortic stenosis in the context of ongoing advancements in structural heart disease interventions and the increasing clinical demand for timely access to TAVI.
Although TAVI volume in Poland continues to rise - (n=4904 in 2024, increase by 21% compared with 2023) - the national rate of 127 procedures per million inhabitants remains below the European average. Very cautious epidemiological simulations published 8 years ago, in the setting of previous valvular guidelines, suggest that the estimated number of TAVI candidates in Poland is close to 11 000/per year. To that end, the requirement for on-site cardiac surgery substantially restricts access, with only 32 of more than 170 interventional cardiology centers in Poland currently offering TAVI. This limited availability contributes to prolonged waiting times for patients already qualified by the Heart Team, often exceeding six months, which is associated with a markedly increased risk of adverse outcomes related to aortic stenosis. With contemporary transcatheter heart valves offering an excellent safety profile, mortality among patients with AS is now higher during the waiting period for TAVI than after the procedure itself. This underscores the urgent need to expand access to this life-saving procedure by enabling no-CSOS centres to perform TAVI in appropriately selected settings.
Available large-scale registries and observational analyses consistently demonstrate that TAVI performed in no-CSOS centers can achieve clinical outcomes comparable to those of centers with surgical backup. These data indicate that, with appropriate patient selection and structured procedural safeguards, the absence of an on-site cardiac surgery does not adversely affect early or mid-term mortality or complication rates. The incidence of complications requiring emergent cardiac surgery is decreasing and well below 0.5%. However, when such events occur, they are associated with very high mortality (reaching up to 50%), which remains substantial regardless of surgical availability. The present study is unique in terms of conceptualization and methodology as unlike other currently being conducted, while providing maximum procedural safety, it does not limit the AS population to non-operable or highest-risk individuals, and therefore making the results potentially transferable to intermediate and low risk cohorts and subsequently making it more relevant in the light of recent valvular guidelines. Also, the exclusion of more complex aortic and access-site cases, or re-do interventions is in line with the already proven concept tested in coronary interventions field, where only the most complex anatomical cases are recommended to be performed at CSOS sites.
A multicenter Polish registry comparing balloon aortic valvuloplasty in stand-alone catheterization laboratories versus centers with on-site cardiac surgery provided important pilot data supporting the feasibility of interventional treatment for aortic stenosis in settings without surgical backup. Despite treating a higher-risk patient population, standalone laboratories demonstrated no significant differences in major adverse events compared with surgical centers. In-hospital mortality was similar - and even numerically lower in the stand-alone group (0.7% vs 2.9%, p=0.14) - while both settings achieved comparable hemodynamic improvement. Collectively, these findings underscore the safety and practicality of performing selected structural interventions without immediate on-site cardiac surgery.
In conclusion, current evidence indicates that, with adequate patient selection and well-defined procedural safeguards, the absence of on-site cardiac surgery does not preclude the safe and effective performance of TAVI. The findings of this study are expected to provide robust, nationally representative data to inform regulatory decisions and support the development of optimized care pathways that expand equitable access to TAVI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVI performed at the center with on-site cardiac surgery | Active comparator | Procedure: transcathter aortic valve implantationstandard of care |
| TAVI performed at the center without on-site cardiac surgery | Experimental | Procedure: transcathter aortic valve implantation |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Severe degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥40 mmHg or jet velocity ≥4.0 m/s or an aortic valve area (AVA) of ≤1 cm2 (or AVA index <0.6 cm2/m2)
- Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II.
- Suitable for percutaneous transfemoral access
- Age ≥70 years
Key exclusion criteria (6 listed)
- Prior aortic valve replacement
- Bicuspid aortic valve on pre-procedural CT
- Contraindication to femoral access
- Other imaging features indicating increased procedural risk (extremely horizontal aorta, severe aortic root dilatation, aortic annulus outside the range of commercially available devices, high coronary risk occlusion)
- Life expectancy <12 month or active malignancy
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 |
|---|---|---|
| transcathter aortic valve implantationPatients with severe native AS who are adjudicated as suitable candidates for transfemoral TAVI by the Heart Team in CSOS centre will be eligible for inclusion in the study. The choice of the transcatheter heart valve will be at the discrection of the local heart team (all available THV's will be allowed). Major anatomical contraindications to inclusion in the trial will include previous aortic valve implantation, native bicuspid aortic valve morphology and CT-derived imaging characteristics indicative of a high risk of access-site and delivery route complications. | Procedure or surgery | TAVI performed at the center with on-site cardiac surgery, TAVI performed at the center without on-site cardiac surgery |
Primary outcome
Early safety
Time frame: 30-days
absence of: (i) all-cause mortality; (ii) stroke; (iii) VARC type 2-4 bleeding; (iv) major vascular or access-related complications; (v) cardiac structural complications; (vi) acute kidney injury stage 3-4; (vii) moderate or severe aortic regurgitation; (viii) new permanent pacemaker implantation; and (ix) device-related surgery or intervention.
2 secondary outcomes
Device success
Time frame: 30-days
clinical efficacy
Time frame: 1 year
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 7 Apr 2026.
- Background: PubMed 40878295Praz F, Borger MA, Lanz J, Marin-Cuartas M, Abreu A, Adamo M, Ajmone Marsan N, Barili F, Bonaros N, Cosyns B, De Paulis R, Gamra H, Jahangiri M, Jeppsson A, Klautz RJM, Mores B, Perez-David E, Poss J, Prendergast BD, Rocca B, Rossello X, Suzuki M, Thiele H, Tribouilloy CM, Wojakowski W; ESC/EACTS Scientific Document Group. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025 Nov 21;46(44):4635-4736. doi: 10.1093/eurheartj/ehaf194. No abstract available.
- Background: PubMed 37877909Genereux P, Sharma RP, Cubeddu RJ, Aaron L, Abdelfattah OM, Koulogiannis KP, Marcoff L, Naguib M, Kapadia SR, Makkar RR, Thourani VH, van Boxtel BS, Cohen DJ, Dobbles M, Barnhart GR, Kwon M, Pibarot P, Leon MB, Gillam LD. The Mortality Burden of Untreated Aortic Stenosis. J Am Coll Cardiol. 2023 Nov 28;82(22):2101-2109. doi: 10.1016/j.jacc.2023.09.796. Epub 2023 Oct 24.
- Background: PubMed 26541169Coffey S, Cairns BJ, Iung B. The modern epidemiology of heart valve disease. Heart. 2016 Jan;102(1):75-85. doi: 10.1136/heartjnl-2014-307020. Epub 2015 Nov 5. No abstract available.
- Individual participant dataSharing planned: Yes. upon reasonable request from third parties
Related trials for Aortic Stenosis
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
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
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transcathter aortic valve implantation in people with Aortic Stenosis, run by Medical University of Warsaw.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 7 Apr 2026. 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?
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?
Early safety (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 NCT07515768, which also lists 3 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 7 Apr 2026.