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Evolut™ EXPAND TAVR II Pivotal Trial

RECRUITING

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

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Study details:

Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL: AVA >1.0 cm² and <1.5cm²; or AVA ≤ 1.0 cm² with AVAI > 0.6cm²/m² if BMI < 30 kg/m²: or AVA ≤ 1.0 cm² with AVAI > 0.5cm²/m² if BMI ≥ 30 kg/m²:

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

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

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/m²

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

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

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Eligibility

Age eligible for study : 65 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-04-27

Primary completion: 2026-02-01

Study completion finish: 2034-12-01

Study type

TREATMENT

Phase

Trial ID

NCT05149755

Intervention or treatment

DEVICE: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)

Conditions

• Moderate Aortic Valve Stenosis

Image related to Moderate Aortic Valve Stenosis

Condition: Moderate Aortic Valve Stenosis
DEVICE: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
Melbourne, Victoria, Australia and more
Sponsor: Medtronic Cardiovascular

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Find a site

Closest Location:

The Alfred Hospital

Research sites nearby

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The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT) Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, \& guideline-directed management \& therapy	DEVICE: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) Patients will have a Transcatheter Aortic Valve Replacement (TAVR) with either an Evolut PRO+ TAVR, or Evolut FX TAVR, heart valve, and given clinical site-determined guideline-directed management and therapy (GDMT).
NO_INTERVENTION: Clinical site determined guideline-directed management and therapy (GDMT) alone Clinical site determined guideline-directed management and therapy (GDMT) alone	Not specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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.	Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.	30 days
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.	Not Specified	2 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline)	Not Specified	1 year
Composite of all-cause mortality and heart failure hospitalizations or events.	Not Specified	2 years
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations	Not Specified	2 years
Heart failure hospitalizations or events.	Not Specified	2 years
All-cause mortality	Not Specified	2 years
Unplanned cardiovascular hospitalizations	Not Specified	2 years
Days alive and free of unplanned cardiovascular hospitalizations	Not Specified	2 years

Frequently Asked Questions

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References

Clinical Trials Gov: Evolut™ EXPAND TAVR II Pivotal Trial