Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation: a Prospective, Multicenter, Randomized Study
New valve procedure for severe leaky aortic valves tested in randomized trial
Plain English Summary
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation is a Not Applicable clinical trial sponsored by Nanjing First Hospital, Nanjing Medical University studying Aortic Valve Disease. This study tests a new way to implant a self-expanding artificial aortic valve using a catheter (transcatheter aortic valve implantation or TAVI) for people with severe aortic regurgitation. It is for patients with severe aortic regurgitation who are at high risk for traditional open-heart surgery or cannot have it. Participants will receive either the new transcatheter valve or standard medical therapy, and will be monitored for outcomes. Alternatives include open-heart surgery to replace the aortic valve or medical management for symptoms. The trial aims to enroll 210 participants.
Official Summary
Prospective, multicenter, randomized trial.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients aged 60 or older with severe aortic regurgitation who have symptoms or specific heart function measurements. Patients must have a certain size of their aortic valve area and a high risk for surgery, or be unable to have surgery due to specific health conditions. Patients with very large ascending aorta, severe coronary artery disease, short life expectancy, very low heart function, or recent heart attack cannot join. Individuals with allergies to study medications or contrast dyes, or other conditions deemed unsuitable by the doctor, will also be excluded. This trial is studying Aortic Valve Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures whether patients experience 'clinical worsening' within 12 months, which indicates if the new valve procedure is as effective as standard care in preventing serious health The specific primary outcome measures are: Clinical worsening (12 months). 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 addresses a significant unmet need for less invasive treatment options for patients with severe aortic regurgitation who are not good candidates for traditional surgery. This research targets Aortic Valve Disease, where improved treatment options are needed.
Investor Insight
This trial investigates a novel transcatheter valve system for a significant patient population, potentially offering a competitive alternative to existing TAVI devices and surgical options, with a hi
Is This Trial Right for Me?
Ask your doctor about the risks and benefits of this new valve procedure compared to surgery or medical therapy. Participation involves receiving either the new valve treatment or standard medical care, with regular follow-up appointments and tests for 12 months. Day-to-day life after the procedure will depend on your recovery, but may involve taking medications and attending follow-up visits. This trial is currently recruiting participants. The trial is being conducted at 1 site. 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: SINGLE
- Enrollment: 210 participants
Interventions
- DEVICE: Transcatheter Aortic Valve Implantation — The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.
- DRUG: Medical therapy — Angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers.
Primary Outcomes
- Clinical worsening (12 months)
Secondary Outcomes
- Procedural complications (12 months)
- 6-minute walk distance (12 months)
- New York Heart Association (NYHA) functional class (12 months)
- Stroke (12 months)
- Mortality (12 months)
Full Eligibility Criteria
Inclusion Criteria: 1. Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) \> 65mm or left ventricular end-systolic dimension (LVESD) \> 50mm; 2. Severe aortic valve regurgitation, and mean pressure gradient \< 20mmHg; Annular perimeter ≤ 85 mm; 3. The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05; 4. STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement: 1. Severe aorta calcification or active ascending aorta atherosclerotic plaque 2. History of mediastinum radiotherapy 3. Past mediastinitis 4. Presence of unobstructed coronary bypass implants 5. Previous more than two cardiothoracic surgeries 6. Liver cirrhosis 7. Other surgical risk factors Exclusion Criteria: 1. Age \< 60 years old; 2. Ascending aorta diameter \>45mm; 3. Coronary multi-vessel disease (SYNTAX score \>32); 4. Life expectancy \<1 year; 5. Left ventricular ejection fraction \<30%; 6. Acute myocardial infarction within 30 days; 7. Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents); 8. Other situations judged by the researcher as unsuitable for participating in the study.
Trial Locations
- Nanjing First Hospital, Nanjing, Jiangsu, China
Frequently Asked Questions
What is clinical trial NCT04864145?
NCT04864145 is a Not Applicable INTERVENTIONAL study titled "Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation." It is currently recruiting and is sponsored by Nanjing First Hospital, Nanjing Medical University. The trial targets enrollment of 210 participants.
What conditions does NCT04864145 study?
This trial investigates treatments for Aortic Valve Disease. The primary condition under study is Aortic Valve Disease.
What treatments are being tested in NCT04864145?
The interventions being studied include: Transcatheter Aortic Valve Implantation (DEVICE), Medical therapy (DRUG). The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.
What does Not Applicable mean for NCT04864145?
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 NCT04864145?
This trial is currently "Recruiting." It started on 2021-05-21. The estimated completion date is 2031-05-30.
Who is sponsoring NCT04864145?
NCT04864145 is sponsored by Nanjing First Hospital, Nanjing Medical University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04864145?
The trial aims to enroll 210 participants. The trial is currently recruiting and accepting new participants.
How is NCT04864145 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT04864145?
The primary outcome measures are: Clinical worsening (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04864145 being conducted?
This trial is being conducted at 1 site, including Nanjing, Jiangsu (China).
Where can I find official information about NCT04864145?
The official record for NCT04864145 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04864145. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04864145 testing in simple terms?
This study tests a new way to implant a self-expanding artificial aortic valve using a catheter (transcatheter aortic valve implantation or TAVI) for people with severe aortic regurgitation. It is for patients with severe aortic regurgitation who are at high risk for traditional open-heart surgery or cannot have it.
Why is this trial significant?
This trial addresses a significant unmet need for less invasive treatment options for patients with severe aortic regurgitation who are not good candidates for traditional surgery.
What are the potential risks of participating in NCT04864145?
Potential risks include bleeding, stroke, infection, or issues with the new valve, such as leakage around it. Some patients may experience side effects like chest pain, shortness of breath, or discomfort at the catheter insertion site. There is a risk that the new valve may not function perfectly or may require further procedures. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04864145?
Ask your doctor about the risks and benefits of this new valve procedure compared to surgery or medical therapy. Participation involves receiving either the new valve treatment or standard medical care, with regular follow-up appointments and tests for 12 months. Day-to-day life after the procedure will depend on your recovery, but may involve taking medications and attending follow-up visits. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04864145 signal from an investment perspective?
This trial investigates a novel transcatheter valve system for a significant patient population, potentially offering a competitive alternative to existing TAVI devices and surgical options, with a hi This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive either the new transcatheter valve or standard medical therapy, and will be monitored for outcomes. 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.
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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.