TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol (NOSCAR-TAVI)

March 31, 2026 updated by: Kajetan Grodecki, Medical University of Warsaw

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
404

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: TAVI performed at the center with on-site cardiac surgery
standard of care
Procedure: transcathter aortic valve implantation
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.
Experimental: TAVI performed at the center without on-site cardiac surgery
Procedure: transcathter aortic valve implantation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30-days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device success
Time Frame: 30-days
successful deployment, correct positioning, no urgent surgery
30-days
clinical efficacy
Time Frame: 1 year
freedom from all-cause mortality, all stroke, hospitalization for valve/procedure-related causes, and unfavorable patient-reported quality of life
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NOSCAR-TAVI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

upon reasonable request from third parties

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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