Evolut™ EXPAND TAVR-II-Pivotal study

Australia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States (ICTRP)

Identifiant de l'essai ICTRP
NCT05149755 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
Evolut™ EXPAND TAVR II Pivotal Trial (BASEC)

Titre académique
Evolut EXPAND TAVR II Pivotal Trial (ICTRP)

Titre public
Evolut EXPAND TAVR II Pivotal Trial (ICTRP)

Maladie en cours d'investigation
Moderate Aortic Valve Stenosis (ICTRP)

Intervention étudiée
Device: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Critères d'inclusion/exclusion
Key Inclusion Criteria:

o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL:

- AVA >1.0 cm and <1.5cm or

- AVA = 1.0 cm with AVAI > 0.6cm/m if BMI < 30 kg/m: or

- AVA = 1.0 cm with AVAI > 0.5cm/m if BMI = 30 kg/m:

and

- Max aortic velocity = 3.0 m/sec. and < 4.0 m/sec. or

- Mean aortic gradient = 20mmHg and < 40.0 mmHg

Any of the following at-risk features:

- Symptoms of AS, defined as:

- NYHA = Class II, or

- Reduced functional capacity, defined as

- 6MWT < 300 meters, or

- < 85% of age-sex predicted METs on exercise tolerance testing (ETT)

- Documented heart failure event or hospitalization for heart failure within 1
calendar year prior to consent

- NT-proBNP = 600 pg/ml (or BNP = 80 pg/ml), or

- Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or

- Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males)
as assessed by the MDCT core lab, or

- Any of the following by the qualifying TTE as assessed by the ECL:

- Global longitudinal strain =16% (absolute value), or

- E/e' = 14.0 (average of medial and lateral velocities), or

- Diastolic dysfunction = Grade II, or

- LVEF < 60%

- Stroke Volume Index < 35 ml/m

- Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or
Evolut FX system

- The subject and the treating physician agree the subject will return for all
required follow-up visits

Key Exclusion Criteria:

- Age < 65 years

- LVEF = 20% by 2-D echo

- Class I indication for cardiac surgery

- Contraindication for placement of a bioprosthetic valve

- Documented history of cardiac amyloidosis (ICTRP)

non disponible

Critères d'évaluation principaux et secondaires
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.;Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention. (ICTRP)

Proportion of subjects alive and with moderately improved quality of life (= 10 points in KCCQ summary score from baseline);Composite of all-cause mortality and heart failure hospitalizations or events.;Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations;Heart failure hospitalizations or events.;All-cause mortality;Unplanned cardiovascular hospitalizations;Days alive and free of unplanned cardiovascular hospitalizations (ICTRP)

Date d'enregistrement
24.11.2021 (ICTRP)

Inclusion du premier participant
non disponible

Sponsors secondaires
non disponible

Contacts supplémentaires
Paul Sorajja, MD;Josep Rodes-Cabau, MD;Stephan Windecker, Prof.;Hang Nguyen, hang.t.nguyen@medtronic.com, 763-526-2832, Allina Health System,Fondation IUCPQ,Inselspital, Universit?tsspital Bern, (ICTRP)

ID secondaires
D00411092 (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05149755 (ICTRP)