Registry for patients undergoing Transcatheter Aortic Valve Replacement
Official title: Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry
Run by Federico II University · NCT05235555 · Data updated 2026-11-12
This study is tracking patients with severe aortic stenosis who are having a new heart valve procedure called TAVI to see how safe and effective it is for their health.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 55 Years to 100 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Status | Recruiting |
| Started | September 1, 2015 |
| Main results expected | September 9, 2021 |
| Study ends | January 1, 2030 |
| Registry record updated | February 23, 2024 |
| Trial ID | NCT05235555 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with symptomatic severe aortic stenosis who are suitable for TAVI as determined by a Heart Team evaluation.
✕Probably not a fit
Patients with contraindications to TAVI or those unable to adhere to follow-up may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry aims to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) in patients with symptomatic severe aortic stenosis. It will collect clinical, procedural, and echocardiographic data to assess the clinical outcomes of the TAVI procedure. The study is conducted at the Federico II University in Naples and focuses on patients deemed suitable for TAVI by a multidisciplinary team. The findings will contribute to understanding the impact of TAVI on patient health and outcomes.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of TAVI's effectiveness and safety, potentially improving treatment options for patients with aortic stenosis.
How similar studies have gone: Previous studies have shown success with TAVI, establishing it as a viable alternative to surgical aortic valve replacement.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation; 2. Ability to provide informed consent. Exclusion Criteria: 1. Contraindications to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis; 2. Poor adherence to scheduled follow-up; 3. Unable to understand and follow study-related instructions.
Where it's running
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Federico II University of Naples
Naples, Italy Recruiting
Study contacts
- Principal investigator: Giovanni Esposito, MD, PhD — Federico II University
- Study coordinator: Giovanni Esposito, MD, PhD
- Email: espogiov@unina.it
- Phone: +390817463075
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How TAVI affects gut bacteria in people with severe aortic stenosis
This will test whether transcatheter aortic valve implantation (TAVI) changes the gut microbiota and related blood markers in people with severe aortic stenosis.
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Using SMART watches to monitor patients after heart valve replacement
This study tests if using a HUAWEI smartwatch to track heart rate, oxygen levels, and activity can help patients who have had heart valve replacement spot problems early and recover better.
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Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
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SYMmetric Valve expansion to reduce hypoattenuated leaflet thickening after balloon-expandable TAVI
This trial tests whether the Double-TAP post-dilatation strategy can reduce HALT and improve valve function in patients 70 or older undergoing balloon-expandable TAVI.
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Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
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Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.