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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02592369




Registration number
NCT02592369
Ethics application status
Date submitted
20/10/2015
Date registered
30/10/2015
Date last updated
30/04/2020

Titles & IDs
Public title
CoreValve™ Evolut R™ FORWARD Study
Scientific title
The Medtronic CoreValve™ Evolut R™ FORWARD Study
Secondary ID [1] 0 0
Evolut R™ FORWARD Study
Universal Trial Number (UTN)
Trial acronym
FORWARD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Medtronic CoreValve™ Evolut R™ System

Treatment: Devices: Medtronic CoreValve™ Evolut R™ System
The Evolut R System is intended for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, to be at high or extreme risk for open heart surgery. The Evolut R TAV treats aortic stenosis by displacing and functionally replacing the dysfunctional native valve with a bioprosthetic valve delivered on a catheter while the heart is still beating, thus avoiding the risks of cardiopulmonary bypass. Its intended performance is to relieve aortic valve stenosis without inducing significant regurgitation, thereby restoring effective aortic valve function.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality rate
Timepoint [1] 0 0
30 days post implant
Secondary outcome [1] 0 0
Device success according to VARC2
Timepoint [1] 0 0
24h to 7 days post implant
Secondary outcome [2] 0 0
Hemodynamic performance
Timepoint [2] 0 0
24h to 7 days and 1 year post implant
Secondary outcome [3] 0 0
Hemodynamic performance
Timepoint [3] 0 0
24h to 7 days and 1 year post implant
Secondary outcome [4] 0 0
Hemodynamic performance
Timepoint [4] 0 0
24h to 7 days and 1 year post implant
Secondary outcome [5] 0 0
Early safety composite endpoint according to VARC2
Timepoint [5] 0 0
30 days post implant
Secondary outcome [6] 0 0
Event rates according to VARC2
Timepoint [6] 0 0
30 days post implant
Secondary outcome [7] 0 0
Rate of new permanent pacemaker implant
Timepoint [7] 0 0
30 days post implant

Eligibility
Key inclusion criteria
- Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined
surgical bioprosthetic valve failure necessitating valve replacement

- Acceptable candidate for elective treatment with the Evolut R System and in conformity
with the local regulatory and medico economic context

- Age =80 years OR considered to be at high or greater risk for surgical aortic valve
replacement (AVR) where high risk is defined as:

- Society of Thoracic Surgeons (STS) predicted risk of mortality =8% OR

- Documented heart team agreement of risk for AVR due to frailty or comorbidities.

- Geographically stable and willing to return to the implanting site for all follow-up
visits

- Of legal age to provide informed consent (patient Informed Consent or Data Release
Form) in the country where they enroll in the trial

- The patient has been informed of the nature of the study, is able and willing to
provide consent without assistance from a legal representative and has consented to
participate, and has authorized the collection and release of his/her medical
information by signing a Patient Informed Consent or Data Release Form.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and
bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to
contrast media, which cannot be adequately premedicated

- Preexisting mechanical heart valve in aortic position

- Ongoing sepsis, including active endocarditis

- Anatomically not suitable for the Evolut R system

- Estimated life expectancy of less than 1 year

- Participating in another trial that may influence the outcome of this trial

- Need for emergency surgery for any reason

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/02/2020
Sample size
Target
Accrual to date
Final
1060
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Fiona Stanley Hospital Perth - Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Canada
State/province [2] 0 0
London
Country [3] 0 0
Canada
State/province [3] 0 0
Toronto
Country [4] 0 0
Canada
State/province [4] 0 0
Vancouver
Country [5] 0 0
Colombia
State/province [5] 0 0
Cali
Country [6] 0 0
Czechia
State/province [6] 0 0
Trinec
Country [7] 0 0
France
State/province [7] 0 0
Creteil
Country [8] 0 0
France
State/province [8] 0 0
Lille
Country [9] 0 0
France
State/province [9] 0 0
Massy
Country [10] 0 0
France
State/province [10] 0 0
Paris
Country [11] 0 0
France
State/province [11] 0 0
Toulouse
Country [12] 0 0
Germany
State/province [12] 0 0
Bad Oeynhausen
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Bonn
Country [15] 0 0
Germany
State/province [15] 0 0
Cottbus
Country [16] 0 0
Germany
State/province [16] 0 0
Dresden
Country [17] 0 0
Germany
State/province [17] 0 0
Duesseldorf
Country [18] 0 0
Germany
State/province [18] 0 0
Essen
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt
Country [20] 0 0
Germany
State/province [20] 0 0
Hamburg
Country [21] 0 0
Germany
State/province [21] 0 0
Karlsruhe
Country [22] 0 0
Germany
State/province [22] 0 0
Leipzig
Country [23] 0 0
Germany
State/province [23] 0 0
Munich
Country [24] 0 0
Greece
State/province [24] 0 0
Athens
Country [25] 0 0
Hungary
State/province [25] 0 0
Budapest
Country [26] 0 0
Israel
State/province [26] 0 0
Tel-Aviv
Country [27] 0 0
Italy
State/province [27] 0 0
Brescia
Country [28] 0 0
Italy
State/province [28] 0 0
Catania
Country [29] 0 0
Italy
State/province [29] 0 0
Milan
Country [30] 0 0
Italy
State/province [30] 0 0
Pisa
Country [31] 0 0
Netherlands
State/province [31] 0 0
Amsterdam
Country [32] 0 0
Netherlands
State/province [32] 0 0
Eindhoven
Country [33] 0 0
Netherlands
State/province [33] 0 0
Nieuwegein
Country [34] 0 0
Netherlands
State/province [34] 0 0
Rotterdam
Country [35] 0 0
Norway
State/province [35] 0 0
Oslo
Country [36] 0 0
Panama
State/province [36] 0 0
Panama
Country [37] 0 0
Poland
State/province [37] 0 0
Warsaw
Country [38] 0 0
Portugal
State/province [38] 0 0
Vila Nova de Gaia
Country [39] 0 0
Saudi Arabia
State/province [39] 0 0
Riyadh
Country [40] 0 0
South Africa
State/province [40] 0 0
Cape Town
Country [41] 0 0
Spain
State/province [41] 0 0
Malaga
Country [42] 0 0
Spain
State/province [42] 0 0
Oviedo
Country [43] 0 0
Spain
State/province [43] 0 0
Santiago de Compostela
Country [44] 0 0
Sweden
State/province [44] 0 0
Uppsala
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Belfast
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Brighton
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Leeds
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiovascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prospective, single arm, multi-center, observational, post market study to document the
clinical and device performance outcomes of the Evolut R system used in routine hospital
practice in a large patient cohort for the treatment of symptomatic native aortic valve
stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure
necessitating valve replacement.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02592369
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eberhard Grube, Prof. Dr.
Address 0 0
University Hospital, Bonn
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02592369