What is this study trying to find out about severe symptomatic aortic stenosis?

This study is evaluating how well the Medtronic Evolut™ FX+ TAVI System works for adults with severe symptomatic aortic stenosis. It aims to see if a standardized implantation procedure improves safety and efficiency, and to track patient outcomes like valve function and complications over time. The study is sponsored by the Portuguese Association of Interventional Cardiology.

Who may be eligible for this severe symptomatic aortic stenosis clinical trial?

Adults aged 18 or older with severe symptomatic aortic stenosis, including symptoms like difficulty breathing or chest pain, may be eligible. People with prior surgical valve implants, advanced liver disease, or very limited life expectancy are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this severe symptomatic aortic stenosis clinical trial?

Study-related care, including the procedure and all trial visits, is provided at no cost. However, personal travel costs may vary and are not guaranteed to be covered. Participants should plan accordingly for their own expenses.

Actively Recruiting

Age: 18Years +

All Genders

ID07343674

PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut FX TAVI System by Evaluating an Optimal Care Pathway for TAVI

Led by Portuguese Association of Interventional Cardiology · Updated on 2026-04-08

500

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to understand how the Medtronic Evolut FX transcatheter aortic valve implantation TAVI System performs in adults with severe, symptomatic aortic stenosis who require valve replacement. The study focuses on whether using a standardized procedure for implanting this valve system can improve safety and efficiency. It also looks at patient outcomes both shortly after the procedure 30 days and in the longer term 1 year, including the need for pacemakers, complications, and valve function. Participants will receive the Medtronic Evolut FX TAVI System as part of their regular medical care for severe aortic stenosis. This is an observational registry capturing routine practice data, with no experimental treatments assigned. The study will follow patients from their hospital stay through 30 days and up to 1 year after the procedure to monitor health and recovery. During the study, participants will be closely observed through hospital records and follow-up visits to assess heart health, valve function, and recovery progress. Researchers will measure technical success immediately after the procedure, as well as monitor events like pacemaker implantation, hospital stay length, mortality, stroke, bleeding, kidney injury, vascular complications, valve issues requiring further treatment, rehospitalizations, and prosthetic valve function over 30 days and 1 year. A total of 500 participants across 12 hospitals will take part in this registry lasting until April 2028.

CONDITIONS

Brief Title

PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults 18 years or older able to provide informed consent
Severe symptomatic aortic stenosis defined as New York Heart Association (NYHA) Class II or higher
Symptoms may include difficulty breathing at rest or exertion, fatigue, chest pain, or fainting
Written informed consent approved by an Ethics Committee

You will not qualify if you...

Presence of a pre-existing surgical bioprosthetic aortic valve
Liver failure classified as Child-Pugh Class B or C
Contraindications to the Medtronic Evolut™ FX+ TAVI System as per instructions
Anatomical unsuitability for the Medtronic Evolut™ FX+ TAVI System
Participation in another clinical investigation that may affect study results
Expected survival less than one year

Research Team

Rui C Teles, MD, PhD

Joana D Silva, MD, PhD

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