Aortic Valve Stenosis
Conditions
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.
Interventions
DEVICEMedtronic 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.
Sponsors
Medtronic Cardiovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality rate | 30 days post implant | All-cause mortality rate at 30 days post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 mean prosthetic valve gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory. |
| 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) |
| 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 |
| Rate of new permanent pacemaker implant | 30 days post implant | Rate of new permanent pacemaker implant at 30 days post procedure |
Countries
Australia, Belgium, Canada, Colombia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Panama, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, United Kingdom
Outcome results
None listed