CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.

Abbott Medical Devices1,001 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,001

Conditions

Symptomatic Degenerative Aortic Stenosis Severe Aortic Stenosis

Interventions

Portico™ Valve, Portico Delivery System(s) and Loading System(s)DEVICE

Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.

Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)DEVICE

Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. 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 Exclusion Criteria: 1. Have sepsis, including active endocarditis 2. Have any evidence of left ventricular or atrial thrombus 3. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable 4. Have a non-calcified aortic annulus 5. Have congenital bicuspid or unicuspid leaflet configuration 6. Are unable to tolerate antiplatelet/anticoagulant therapy 7. Are pregnant at the time of signing informed consent 8. Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)

Locations (28)

Outcomes

Primary Outcomes

Cardiovascular Mortality

Death due to proximate cardiac cause, non-coronary vascular conditions, procedure-related deaths, valve-related deaths, sudden or unwitnessed death and unknown cause.

Time frame: 30 days from the index procedure

Secondary Outcomes

Number of Subjects With Myocardial Infarction

Time frame: At 30 days

Number of Subjects With Stroke

Time frame: At 30 days

Number of Subjects With Bleeding Events

Time frame: At 30 days

Number of Subjects With Acute Kidney Injury

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.

Time frame: At 30 days

Number of Subjects With Vascular Complications

Time frame: At 30 days

Number of Subjects With Annular Rupture

Time frame: At 30 days

Data from ClinicalTrials.gov

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NYHA Classification

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).

Time frame: At 30 days