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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05149755




Registration number
NCT05149755
Ethics application status
Date submitted
24/11/2021
Date registered
8/12/2021
Date last updated
4/11/2024

Titles & IDs
Public title
Evolut™ EXPAND TAVR II Pivotal Trial
Scientific title
Evolut™ EXPAND TAVR II Pivotal Trial
Secondary ID [1] 0 0
D00411092
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)

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

No intervention: Clinical site determined guideline-directed management and therapy (GDMT) alone - Clinical site determined guideline-directed management and therapy (GDMT) alone


Treatment: Devices: 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).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.
Timepoint [2] 0 0
2 years
Secondary outcome [1] 0 0
Proportion of subjects alive and with moderately improved quality of life (= 10 points in KCCQ summary score from baseline)
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Composite of all-cause mortality and heart failure hospitalizations or events.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Heart failure hospitalizations or events.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
All-cause mortality
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Unplanned cardiovascular hospitalizations
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Days alive and free of unplanned cardiovascular hospitalizations
Timepoint [7] 0 0
2 years

Eligibility
Key inclusion criteria
Key

o 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:

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/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

Key
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2034
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiovascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
Trial website
https://clinicaltrials.gov/study/NCT05149755
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Sorajja, MD
Address 0 0
Allina Health System
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hang Nguyen
Address 0 0
Country 0 0
Phone 0 0
763-526-2832
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05149755