Aortic Valve Stenosis
Conditions
Brief summary
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system. The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.
Detailed description
Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device.
Interventions
DEVICEMedtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system
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 * High or greater risk for surgical aortic valve replacement as estimated by the heart team OR, 75 years or older and at intermediate risk for surgical AVR (STS risk score ≥4% or with an estimated hospital mortality ≥4% as assessed by the heart team) * Acceptable candidate for treatment with the Evolut™ PRO system in conformity with the Instructions for Use and the local regulations * Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year * Written informed consent obtained without assistance from a legal representative prior to enrollment in the study.
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™ PRO system * Estimated life expectancy of less than 1 year * Participating in another trial that may influence the outcome of this study * Need for emergency surgery for any reason * Inability to understand and respond to the quality of life questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 days post procedure | The all-cause mortality rate at 30 days post procedure meets a prespecified performance goal of 5.5%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VARC-2 composite safety endpoint | through 5 years from enrollment until end of study | Event rate of the VARC-2 composite safety endpoint through 5 years from enrollment until end of study, which includes 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) |
| Individual components of the VARC-2 composite safety endpoint | through 5 years from enrollment until end of study | Event rates of the individual components of the VARC-2 composite safety endpoint through 5 years until end of study |
| Rate of new permanent pacemaker implant | 30 days post procedure | Rate of new permanent pacemaker implant at 30 days post procedure |
| Total AR | 24 hours to 7 days post procedure (prior to discharge) | The percentage of subjects graded as none or trace total aortic regurgitation at discharge is greater than a prespecified performance goal of 67.1%. |
| Hemodynamic performance | 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post | Hemodynamic performance at 24 hours to 7 days (prior to discharge), 1-year, 3-year and 5-year post procedure, including the mean prosthetic valve gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory. |
| Change in NYHA functional status | From baseline to 30-day, 1-year, 3-year, and 5-year post procedure | Change in NYHA functional status from baseline to 30-day, 1-year, 3-year, and 5-year post procedure |
| Change in Quality of Life score | From baseline to 30-day, and 1-year, 3-year, and 5-year post procedure | Change in Quality of Life score (EQ-5D questionnaire) from baseline to 30-day, and 1-year, 3-year, and 5-year post procedure. The EQ-5D descriptive system comprises five dimensions and each dimension has five levels of severity. The subject is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the five dimensions. The EQ VAS records the subject's self-rated health on a 20 cm vertical, visual analogue scale. The subject marks an X on the scale to indicate how his/her health is TODAY and then writes the number they marked on the scale in the box below. |
| Device success rate | 24 hours to 7 days post procedure (prior to discharge) | Device success rate at 24 hours to 7 days post procedure (prior to discharge), defined according to the 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. |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Slovenia, Spain, Switzerland, United Kingdom
Outcome results
None listed