CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
- Conditions
- Symptomatic Degenerative Aortic StenosisSevere Aortic Stenosis
- Interventions
- Device: Portico™ Valve, Portico Delivery System(s) and Loading Systems(s)Device: Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s)
- Registration Number
- NCT03752866
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.
- Detailed Description
The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study.
Approximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), will undergo Portico™ Transcatheter Aortic Heart Valve implantation.
The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1001
- Subjects who are ≥18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant
- Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center
- Have sepsis, including active endocarditis
- Have any evidence of left ventricular or atrial thrombus
- Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
- Have a non-calcified aortic annulus
- Have congenital bicuspid or unicuspid leaflet configuration
- Are unable to tolerate antiplatelet/anticoagulant therapy
- Are pregnant at the time of signing informed consent
- Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Portico™ Valve, Delivery System(s) and Loading Systems(s) Portico™ Valve, Portico Delivery System(s) and Loading Systems(s) Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems Portico™ Valve, FlexNav Delivery and Loading System(s) Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s) Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems
- Primary Outcome Measures
Name Time Method Cardiovascular Mortality 30 days from the index procedure Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.
- Secondary Outcome Measures
Name Time Method Number Of Subjects With Valve Embolization At 30 days Number of Subjects With Myocardial Infarction At 30 days Number of Subjects With Stroke At 30 days Number of Subjects With Bleeding Events At 30 days Number of Subjects With Acute Kidney Injury At 30 days The increase in creatinine must occur within 48 hours.
Stage 1: Increase in serum creatinine to 150% to 199% (1.5 to 1.99 X increase compared with baseline) or increase of greater than or equal to 0.3 mg/dL (26.4 mmol/L) or Urine output \<0.5 mL/kg per hour for \>6 but \<12 hours.
Stage 2: Increase in serum creatinine to 200% to 299% (2.0 to 2.99 X increase compared with baseline) or Urine output \<0.5 mL/kg per hour for \>12 but \<24 hours.
Stage 3: Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output \<0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.Number of Subjects With Vascular Complications At 30 days Number of Subjects With Annular Rupture At 30 days Number of Subjects With Coronary Obstruction At 30 days Number of Subjects Undergoing Conversion To Open Surgery At 30 days Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment At 30 days Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion At 30 days Vessel Diameter At 30 days Introducer Sheath Used At 30 days This is a yes or no question on the CRF. Sites report if the implanter used an introducer sheath (a special device used to facilitate introduction of the investigational device into the subjects vasculature).
Implant Success At 30 days Effective Orifice Area At 30 days Effective orifice area is a measure of the working area of the implanted valve determined by echocardiograph.
Aortic Valve Mean Gradient At 30 days Aortic valve mean gradient is a measure of the pressure gradient across the aortic valve measured by echocardiograph.
Number of Subjects With Paravalvular Leak (PVL) At 30 days NYHA Classification At 30 days NYHA Functional Classification is a system used to assess patient heart failure severity based on their limitations of physical activity. The four classes are described below:
Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or shortness of breath.
Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Subjects' NYHA Classification based on above criteria was assessed during follow up, and subjects were assigned to one of four classifications. Results are presented as percentage of all available subjects who were assigned each functional class (I-IV).EQ5D-3L Visual Analog Scale Value At 30 days The EQ-5D-3L consists of EuroQoL 5 questions and 3 answering levels. The rating of questions includes: Level 1 no problems; Level 2 some problems; Level 3 Significant problems; Worst case is 15 points; and best case is 5 points using index. The Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state."
Kaplan-Meier Rate of All-cause Mortality At 12 months Kaplan-Meier (KM) percentage of subjects who died. KM is a statistical method that attempts to account for other factors that may have reduced the number of subjects evaluable at a given time point.
Trial Locations
- Locations (28)
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Hospital de la Santa Creu I Sant Pau
🇪🇸Barcelona, Catalonia, Spain
St.-Johannes-Hospital
🇩🇪Dortmund, Germany
Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV
🇩🇪Karlsruhe, Germany
Hospital General Juan Ramon Jimenez
🇪🇸Huelva, Spain
Kliniken der Friedrich-Alexander-Universitat
🇩🇪Erlangen, Bavaria, Germany
Policlinico San Donato
🇮🇹San Donato Milanese, Italy
Policlinico di Monza
🇮🇹Monza, Lombardy, Italy
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Samodzielny Publiczny Centralny Szpital Kliniczny
🇵🇱Warsaw, Mazovia, Poland
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
🇩🇪Frankfurt, Germany
Ospedale San Raffaele
🇮🇹Milano, Italy
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
James Cook University Hoospital
🇬🇧Middlesbrough, North East England, United Kingdom
AZ Middelheim
🇧🇪Antwerpen, Belgium
Heart Care Partners- Wesley Hospital
🇦🇺Woolloongabba, Queensland, Australia
Kerckhoff-Klinik gGmbH
🇩🇪Bad Nauheim, Germany
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
🇩🇪Berlin, Germany
Herzzentrum Dresden GmbH Universitätsklinik
🇩🇪Dresden, Germany
Charite Campus Virchow Klinikum
🇩🇪Berlin-Mitte, Germany
Universitätsmedizin Berlin - Charité Campus Mitte (CCM)
🇩🇪Berlin, Germany
UKE Hamburg (Universitatsklinik Eppendorf)
🇩🇪Hamburg, Germany
Ospedale San Bortolo
🇮🇹Vicenza, Italy
Royal Victoria Hospital
🇬🇧Belfast, Ireland, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Morriston Hospital - ABM University Health Board
🇬🇧Morriston, Swansea, United Kingdom