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NCT Number: NCT07343674

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

The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement.

The main questions it aims to answer are:

* Can using a standardized procedure for the impantation of the Medtronic Evolut™ FX+ TAVI System increase safety and efficiency? * What are the short-term (30 days) and long-term (1 year) patient outcomes, including the need for a pacemaker, complications, and valve function?

Participants will undergo TAVI with the Medtronic Evolut™ FX+ TAVI System as part of their routine care.

Be followed during their hospital stay, at 30 days, and at 1 year to check heart health, valve function, and recovery. 500 people at 12 hospitals in Portugal will take part in this registry.

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Key information

Conditions

Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II) Aortic Valve Disease Aortic Valve Stenosis Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospitais da Universidade de Coimbra, Coimbra, Coimbra District, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects more than 18 years old, able to provide an Informed Consent:
  • Severe symptomatic (defined as New York Heart Association (NYHA) class ≥ II) aortic stenosis (AS), including but not limited to: Dyspnea at rest or on exertion, fatigue, angina, syncope in the absence of another identifiable cause;
  • Subjects provided written Informed Consent as approved by the Ethics Committee (EC);

Exclusion criteria

  • Subjects with pre-existing surgical bioprosthetic aortic valve;
  • Hepatic insufficiency (Child-Pugh Class B or C);
  • Contraindicated for treatment with the Medtronic Evolut™ FX+ TAVU System in accordance with the Instructions for Use (IFU);
  • Anatomically considered not suitable for the Medtronic Evolut™ FX+ TAVI system;
  • Subjects are currently participating in another clinical investigation that may confound the results of this Registry;
  • Subjects have an expected survival less than one year.

Treatment and study plan

Primary outcomes

  1. VARC-3 technical success

    Time frame: Immediately after the index procedure

    A composite outcome assessed immediately after the TAVI procedure, including: survival, successful vascular access and device deployment/retrieval, correct positioning of a single valve, and freedom from major complications or need for surgery/intervention (excluding pacemaker).

Secondary outcomes

  1. Rate of Permanent Pacemaker Implantation (PPI)

    Time frame: 30 days after procedure

    Percentage of participants who require a new permanent pacemaker due to new or worsening conduction disturbances.

  2. Length of Hospital Stay

    Time frame: Up to 30 days after procedure

    Number of days from TAVI procedure to discharge.

  3. All-Cause Mortality

    Time frame: 30 days and 1 year

    Death from any cause.

  4. Stroke

    Time frame: 30 days and 1 year

    Any new neurologic deficit classified as a stroke by clinical evaluation.

  5. Life-Threatening Bleeding

    Time frame: 30 days and 1 year

    Severe bleeding events defined by VARC-3 criteria.

  6. Acute Kidney Injury

    Time frame: 30 days and 1 year

    Kidney dysfunction as defined by VARC-3 criteria.

  7. Coronary Artery Obstruction

    Time frame: 30 days and 1 year

    Blockage requiring clinical intervention.

  8. Major Vascular Complications

    Time frame: 30 days and 1 year

    Serious vascular complications as defined by VARC-3 criteria

  9. Valve Dysfunction Requiring Reintervention

    Time frame: 30 days and 1 year

    Prosthetic valve dysfunction that requires repeat procedure.

  10. Rehospitalization

    Time frame: 30 days and 1 year

    Rehospitalization for valve-related symptoms or worsening heart failure.

  11. Prosthetic Valve Function

    Time frame: 30 days and 1 year

    Echocardiographic measures of valve function: left ventricular ejection fraction, peak velocity, mean gradient, effective orifice area, indexed effective orifice area, and prosthetic aortic valve regurgitation.

    It is defined as YES if: peak velocity is < 3 m/s AND mean gradient < 20 mmHg AND DVI > 0,25* AND Regurgitation < moderate (this means that LV and index EOA are indirectly in it, no cutt offs are needed)

    • DVI is the ratio of the Velocity-Time Integral (VTI) in the Left Ventricular Outflow Tract (LVOT) to the VTI across the stenotic aortic valve. It is measured based on the peak velocity /Grad, Effective orifice area (cm²)

Other outcomes

  1. Procedural Technique Compliance (TAVI.PTrainer Survey)

    Time frame: During the index procedure

    Assessment of operator adherence to standardized TAVI procedural steps, including Cusp Overlap Technique, using a dedicated checklist tool.

  2. Correlation of Procedural Compliance with Clinical Outcomes

    Time frame: Procedure through 1 year

    Analysis of whether higher compliance with optimized TAVI procedural steps is associated with better patient outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Joana D Silva, MD, PhD

CONTACT

[email protected]

Rui C Teles, MD, PhD

CONTACT

[email protected]

(+351) 210 433 069

Sponsors and collaborators

Lead sponsor

Portuguese Association of Interventional Cardiology

Other

Collaborators

  • Medtronic

Registry information

Acronym: PERFECT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 15, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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