Aortic Stenosis
Conditions
Keywords
Transcatheter aortic valve implantation (TAVI), ACURATE neo2™ bioprosthetic aortic valve, ACURATE neo2™ transfemoral delivery system
Brief summary
Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve implantation). The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, hereafter referred to as the ACURATE neo2™ and transfemoral delivery system in the context of an observational investigator initiated trial (IIT).
Detailed description
There are four leading causes of valvular aortic valve stenosis, namely: calcific aortic stenosis, congenital aortic valve malformations, rheumatic aortic valve stenosis, and endocarditis. Calcific aortic valve stenosis is a chronic progressive disease, and the predominant cause of aortic valve stenosis in the Western world. Multiple mechanisms influencing the progression of aortic valve stenosis have been identified. However, there is still no sufficient drug therapy to stop or reverse the process. If high-grade aortic valve stenosis becomes symptomatic, death rates increase up to 50% in 2 years.Many patients with severe and symptomatic aortic stenosis are successfully treated with surgical aortic valve replacement (SAVR), which can reduce symptoms and improve survival. However, up to one-third of symptomatic patients are considered inoperable due to comorbidities and the high risk of surgery. This treatment gap forced the development of less invasive approaches for patients with aortic stenosis considered inoperable and led to the development of TAVI. Later, TAVI has also been considered in the European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2017 and American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the management of patients with valvular heart disease and intermediate surgical risk and recently, new landmark studies have expanded the use of TAVI into the low surgical risk field. For the establishment of TAVI as the first line treatment option in lower risk patients, further improvement with regard to adverse outcomes associated with TAVI (e.g. vascular complications, rates of paravalvular leak/aortic regurgitation and the need for permanent pacemakers) will be essential. Therefore, large registries are needed to detect rare events and tendencies in a real-world setting. The PROVE study will collect baseline, procedural and follow-up data. In addition, it will serve as an imaging library (angiography, echocardiography and cardiac computed tomography) to evaluate the potential advantages and disadvantages of the ACURATE neo2.
Interventions
DEVICEPlanned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.
The study will collect data from patients treated with the ACURATE neo2™ and its transfemoral delivery system following standard TAVI practice at each participating center. All patients will be followed to 12 months after the implant procedure. The study is divided into three periods: 1. Screening period: from screening to enrollment if study criteria are met. 2. Implantation procedure: immediately pre-implant to 24 hours post-procedure. 3. Follow-up period: at hospital discharge, at 30 days and at 12 months post-procedure.
Sponsors
National University of Ireland, Galway
University of Leipzig
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Planned transcatheter treatment of severe aortic stenosis with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system. * Age ≥ 18 years of age * Written informed consent by patient and/or legal representative
Exclusion criteria
* Patient is unlikely to be able or willing to follow the investigator's instructions during study participation. * Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients) * 3\. Patients placed in an institution by official or court order
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to all-cause death | through study completion, an average of 1 year | The individual survival time is calculated from the day of procedure up to death of any cause or up to the last last date on which the patient was known to be alive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vascular and access-related complications (count) | through study completion, an average of 1 year | Numbers by type and severity |
| Bioprosthetic valve dysfunction (rate) | through study completion, an average of 1 year | Rates by type |
| Clinically significant valve thrombosis (count) | through study completion, an average of 1 year | Numbers by timing period |
| Clinically significant valve thrombosis (rate) | through study completion, an average of 1 year | Rates by timing period |
| Patient-reported outcomes and health status | through study completion, an average of 1 year | Kansas City Cardiomyopathy Questionnaire (KCCQ) |
| Mortality (count) | through study completion, an average of 1 year | Numbers by cause and timing period |
| Mortality (rate) | through study completion, an average of 1 year | Rates, by cause and timing period |
| Neurological events (count) | through study completion, an average of 1 year | Numbers by type, grading and timing |
| Neurological events (rate) | through study completion, an average of 1 year | Rates by type, grading and timing |
| Myocardial infarction (count) | through study completion, an average of 1 year | Numbers by type |
| Myocardial infarction (rate) | through study completion, an average of 1 year | Rates, by type |
| Re-hospitalization (count) | through study completion, an average of 1 year | Re-hospitalization yes/no: numbers -\> Total number of re-hospitalization per patient, by type |
| Re-hospitalization (cumulative incidence) | through study completion, an average of 1 year | Re-hospitalization yes/no: rates Cumulative incidence of first re-hospitalization, by type |
| Bleeding events (count) | through study completion, an average of 1 year | Numbers by type |
| Bleeding events (rate) | through study completion, an average of 1 year | Rates by type |
| Transfusions | through study completion, an average of 1 year | Total number per patient, by timing period |
| Vascular and access-related complications (rate) | through study completion, an average of 1 year | Rates by type and severity |
| Cardiac structural complications (count) | through study completion, an average of 1 year | Numbers by severity |
| Cardiac structural complications (rate) | through study completion, an average of 1 year | Rates by severity |
| Other acute procedural and technical valve related complications (count) | through study completion, an average of 1 year | Numbers by category and type of clinical presentation |
| Other acute procedural and technical valve related complications (rate) | through study completion, an average of 1 year | Rates by category and type of clinical presentation |
| Conduction disturbances and arrhythmia (count) | through study completion, an average of 1 year | Numbers by type, timing and duration |
| Conduction disturbances and arrhythmia (rate) | through study completion, an average of 1 year | Rates by type, timing and duration |
| Acute kidney injury (count) | through study completion, an average of 1 year | Numbers by stage |
| Acute kidney injury (rate) | through study completion, an average of 1 year | Rates by stage |
| Bioprosthetic valve dysfunction (count) | through study completion, an average of 1 year | Numbers by type |
Other
| Measure | Time frame | Description |
|---|---|---|
| Early safety | at 30 days post procedure | Determined at 30 days post procedure |
| Clinical efficacy | at 12 months post procedure | Determined at 12 months post procedure |
| Composite endpoint: device success | at 30 days post procedure | According to VARC-3 criteria |
| Composite endpoint: technical success | at exit from procedure room | According to Valve Academic Research Consortium (VARC)-3 criteria |
Countries
France, Germany, Sweden, Switzerland
Outcome results
None listed