Transcatheter Aortic Valve Implantation Without On-Site Cardiac Surgery in Poland: Protocol for a Multicenter Prospective Randomized Open-label Clinical Trial
Trial tests TAVI without on-site surgery in Poland
Plain English Summary
TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol is a Not Applicable clinical trial sponsored by Medical University of Warsaw studying Aortic Stenosis. This trial tests if Transcatheter Aortic Valve Implantation (TAVI) is safe and effective when performed at hospitals without a cardiac surgery team present. It is for patients with severe aortic stenosis who are recommended for TAVI. Patients will be randomly assigned to have TAVI at a hospital with or without on-site cardiac surgery. Alternatives include traditional open-heart surgery or medical management for those not eligible for TAVI. The trial aims to enroll 404 participants.
Official 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. 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients aged 70 years or older with severe aortic stenosis causing symptoms (difficulty breathing or fatigue). Patients must be suitable for a transfemoral TAVI procedure (access through the leg artery). Patients who have had a previous aortic valve replacement, have a bicuspid aortic valve, or have other conditions making the procedure too risky cannot join. Individuals with a life expectancy of less than 12 months or active cancer are also excluded. This trial is studying Aortic Stenosis, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures early safety within 30 days, meaning it will track major complications or death after the TAVI procedure. The specific primary outcome measures are: Early safety (30-days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it could expand access to TAVI by allowing it at more centers, potentially reducing wait times and improving care for patients with aortic stenosis. This research targets Aortic Stenosis, where improved treatment options are needed.
Investor Insight
This trial addresses a potential bottleneck in TAVI delivery, aiming to increase procedural capacity and potentially capture a larger market share for TAVI procedures by enabling them in non-surgical
Is This Trial Right for Me?
Ask your doctor if TAVI is right for you and what the risks and benefits are. Understand that you will be randomly assigned to a hospital with or without on-site surgery. Participation involves regular check-ups and monitoring after the procedure. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 404 participants
Interventions
- 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 ind
Primary Outcomes
- Early safety (30-days)
Secondary Outcomes
- Device success (30-days)
- clinical efficacy (1 year)
Full Eligibility Criteria
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
Frequently Asked Questions
What is clinical trial NCT07515768?
NCT07515768 is a Not Applicable INTERVENTIONAL study titled "TAVI Without On-Site Cardiac Surgery in Poland: A Randomized Multicenter Trial Protocol." It is currently not yet recruiting and is sponsored by Medical University of Warsaw. The trial targets enrollment of 404 participants.
What conditions does NCT07515768 study?
This trial investigates treatments for Aortic Stenosis. The primary condition under study is Aortic Stenosis.
What treatments are being tested in NCT07515768?
The interventions being studied include: transcathter aortic valve implantation (PROCEDURE). 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 ind
What does Not Applicable mean for NCT07515768?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07515768?
This trial is currently "Not Yet Recruiting." It started on 2026-09-01. The estimated completion date is 2030-09-01.
Who is sponsoring NCT07515768?
NCT07515768 is sponsored by Medical University of Warsaw. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07515768?
The trial aims to enroll 404 participants. The trial has not yet started recruiting.
How is NCT07515768 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07515768?
The primary outcome measures are: Early safety (30-days). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07515768?
The official record for NCT07515768 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07515768. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07515768 testing in simple terms?
This trial tests if Transcatheter Aortic Valve Implantation (TAVI) is safe and effective when performed at hospitals without a cardiac surgery team present. It is for patients with severe aortic stenosis who are recommended for TAVI.
Why is this trial significant?
This trial matters because it could expand access to TAVI by allowing it at more centers, potentially reducing wait times and improving care for patients with aortic stenosis.
What are the potential risks of participating in NCT07515768?
The main risks include bleeding, stroke, damage to the blood vessels, and complications related to the new valve. There is a small risk of needing emergency surgery or experiencing heart rhythm problems. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07515768?
Ask your doctor if TAVI is right for you and what the risks and benefits are. Understand that you will be randomly assigned to a hospital with or without on-site surgery. Participation involves regular check-ups and monitoring after the procedure. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07515768 signal from an investment perspective?
This trial addresses a potential bottleneck in TAVI delivery, aiming to increase procedural capacity and potentially capture a larger market share for TAVI procedures by enabling them in non-surgical This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Patients will be randomly assigned to have TAVI at a hospital with or without on-site cardiac surgery. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.