JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

Not Applicable

Active, not recruiting

• Conditions: Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Heart Diseases; Cardiovascular Diseases
• Interventions: Device: JenaValve Pericardial TAVR System

• Registration Number: NCT02732691
• Lead Sponsor: JenaValve Technology, Inc.

Brief Summary

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Detailed Description

This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.

Study Timeline

• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-11
• Study Start: 2016-10-21
• Primary Completion: 2019-05-28
• Results First Submitted: 2022-09-07
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-28
• Last Update Submitted: 2022-10-28
• Results First Posted: 2022-11-22
• Last Update Posted: 2022-11-22
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Patient with severe degenerative native aortic stenosis (AS).
• Patient at high risk for open surgical valve replacement
• Patient symptomatic according to NYHA functional class II or higher

Exclusion Criteria

• Congenital uni- or bicuspid aortic valve morphology
• Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
• Endocarditis or other active infection
• Need for urgent or emergent TAVR procedure for any reason
• Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcatheter Aortic Valve Replacement (TAVR)	JenaValve Pericardial TAVR System	Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.

Primary Outcome Measures

Name	Time	Method
All-Cause Mortality	30 Day	All-cause mortality rate at 30 Day

Secondary Outcome Measures

Name	Time	Method
Myocardial Infarction	30 Day	Peri-procedural and spontaneous myocardial infarction
Major Vascular Complication	30 Day	Major vascular and bleeding complications
Conversion to Surgical Aortic Valve Replacement (SAVR)	30 Day	Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications
Major Bleeding	30 Day	Life threatening or major bleeding
Coronary Obstruction Requiring Intervention	30 Day	Coronary obstruction post-implant requiring intervention
Endocarditis	30 Day	Bacterial endocarditis
All Stroke/TIA	30 Day	Neurological Complications
Conduction Disturbance and Arrhythmias	30 Day	Conduction system injury (defect), including AV block, which may require a permanent pacemaker
Acute Kidney Injury (AKI)	30 Day	Number of patients who were diagnosed with AKI Stage 2 or 3: AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output \<0.5 mL/kg/h for \>12 but \<24 h; AKI Stage 3: Increase in serum creatinine to ≥300% (\>3 × 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/h for ≥24 h OR anuria for ≥12 h
THV Malpositioning	30 Day	Number of patients who experienced: Migration: After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences; Embolization: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus; Ectopic Valve Deployment: Permanent deployment of the valve prosthesis in a location other than the aortic root

Trial Locations

Locations (13)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Universitäts-Herzzentrum Freiburg/Bad Krozingen; 🇩🇪 Freiburg, Germany

Universitätsklinikum Halle; 🇩🇪 Halle (Saale), Germany

Herzzentrum der Universität zu Köln; 🇩🇪 Köln, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

Universitäres Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Waikato Hospital; 🇳🇿 Hamilton, New Zealand

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands