CoreValve™ Evolut R™ FORWARD Study

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT02592369
• Lead Sponsor: Medtronic Cardiovascular

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.

Detailed Description

The study objective is 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.

Prospective, single arm, multi-center, observational, post market study. In Australia and Canada it is a prospective, single arm, multi-center pre-market study.

Up to 60 centers worldwide. Geographies may include Europe, Australia, Middle East and Africa, Latin America and Canada.

Approximately 1000 implanted subjects, consented for follow-up through three years.

For each subject, data will be collected preoperatively, intra-operatively, at hospital discharge, 30 days, 1, 2 and 3 years.

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-30
• Study Start: 2016-01
• Primary Completion: 2017-02
• Study Completion: 2020-02-06
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1060

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.

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality rate	30 days post implant	All-cause mortality rate at 30 days post procedure

Secondary Outcome Measures

Name	Time	Method
Rate of new permanent pacemaker implant	30 days post implant	Rate of new permanent pacemaker implant at 30 days post procedure
Device success according to VARC2	24h to 7 days post implant	Device success rate at 24 hours to 7 days, defined according to the Valve Academic Research Consortium-2 (VARC-2) guidelines as: * Absence of procedural mortality, AND; * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND; * Intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis mismatch and mean gradient \< 20 mmHg (or peak velocity \< 3 m/sec), AND No moderate or severe prosthetic valve regurgitation.
Early safety composite endpoint according to VARC2	30 days post implant	Early Safety composite endpoint at 30 days post procedure, defined according to the VARC-2 guidelines, defined as any of the following components: * All-cause mortality; * All stroke (disabling and non-disabling); * Life-threatening bleeding; * Acute kidney injury: stage 2 or 3 (including renal replacement therapy); * Coronary artery obstruction requiring intervention; * Major vascular complication; * Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
Hemodynamic performance	24h to 7 days and 1 year post implant	Hemodynamic performance at 24 hours to 7 days (discharge) and 1 year post procedure, including the degree of prosthetic valve regurgitation (transvalvular, paravalvular, and total) as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.
Event rates according to VARC2	30 days post implant	Event rates of the individual components of the VARC-2 composite Early Safety endpoint at 30 days post procedure

Trial Locations

Locations (54)

Flinders Medical Centre; 🇦🇺 Adelaide, Australia

Monash Medical Centre; 🇦🇺 Melbourne, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Australia

Fiona Stanley Hospital Perth; 🇦🇺 Perth, Australia

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

London Health Sciences Centre - University Campus; 🇨🇦 London, Canada

Sunnybrook Health Sciences Center; 🇨🇦 Toronto, Canada

Saint Paul's Hospital; 🇨🇦 Vancouver, Canada

Angiografia de Occidente S.A.; 🇨🇴 Cali, Colombia

Nemocnice Podlesi a.s.; 🇨🇿 Trinec, Czechia

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