AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System

Not Applicable

Recruiting

• Conditions: Mitral Regurgitation; Mitral Valve Disease
• Interventions: Device: Cardiovalve Transfemoral Mitral Valve

• Registration Number: NCT03339115
• Lead Sponsor: Cardiovalve Ltd.

Brief Summary

This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation. Data collected in this clinical study will include 30-day safety and performance, and long-term clinical outcomes over a follow-up of 2 years.

Detailed Description

The Cardiovalve offers a mitral replacement valve delivered through a transfemoral access and transseptal approach, and is intended to reduce mortality and adverse event rates in selected patients for whom surgical options are not feasible.

Innovation: A truly trans femoral, trans venous delivery of the prosthetic mitral valve which minimizes procedural risk. The Cardiovalve Implant features a dual nitinol frame for robust radial strength with decoupling of the atrial flange and ventricular portion which contains 24 grasping legs designed for atraumatic anchoring of the device to the native mitral annulus. Valve leaflets are made of bovine pericardium. The Cardiovalve implant has a very low left ventricle (LV) protrusion footprint thus reducing the risk of LV outflow tract obstruction and/or interference with the LV. The Cardiovalve delivery system (DS) is designed for transfemoral delivery of the Implant with transseptal access to the left atrium. The catheter assembly is used to center the implant relative to the native mitral valve plane and align it with the left ventricual apex-to-base axis. After valve implantation, the delivery system is withdrawn.

Study Timeline

• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-13
• Study Start: 2018-04-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiovalve Transfemoral Mitral Valve	Cardiovalve Transfemoral Mitral Valve	Mitral replacement valve delivered through a transfemoral access and transseptal approach

Primary Outcome Measures

Name	Time	Method
The primary safety endpoint is freedom from all-cause mortality and major adverse events	30 days, 3 Months, 6 Months, 12 Months, and 24 Months	Freedom from all-cause mortality, all cause hospitalization, major adverse cardiac events (MACE), major device- or procedure- related serious adverse events

Secondary Outcome Measures

Name	Time	Method
Device Success	30 days, 3 Months, 6 Months, 12 Months, and 24 Months	IV. Continued intended safety and performance of the device including: 1. No evidence of structural or functional failure; 2. No specific device-related technical failure issues and complications; 3. Reduction in MR grade to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR). Number of patients with reduction in MR grade from baseline
Patient Success	30 days, 3 Months, 6 Months, 12 Months, and 24 Months	I. Device success (either optimal or acceptable) II. Patient returned to the pre-procedural setting; * III. Freedom from rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, worsening of heart failure); * IV. Improvement from baseline in NYHA functional class Number of patients with improvement in NYHA class; * V. Six minute walk test Increase in distance (m) from baseline; * VI. Improvement from baseline in quality-of-life (Kansas City Cardiomyopathy Questionnaire improvement by ≥ 10)
Technical success	Intraoperative, 30 Days	Technical success: I. Absence of procedural mortality; II. Delivery and deployment of the device in the correct position and retrieval of delivery catheter, without significant mitral stenosis, LVOT obstruction or paravalvular MR documented by intraoperative imaging \[Time Frame:Intraoperative\]; III. Freedom from emergency surgery or reintervention related to the device or access procedure \[Time Frame: 30 days\]

Trial Locations

Locations (11)

Herzzentrum der Uniklinik Köln; 🇩🇪 Köln, Germany

Universitaet_Mainz; 🇩🇪 Mainz, Germany

Studienzentrale der Medizinische Klinik II Universitäres Herzzentrum Lübeck; 🇩🇪 Lübeck, Germany

Klinikum der Universität München LMU; 🇩🇪 München, Germany

Maria Cecilia Hospital; 🇮🇹 Cotignola, Italy

Fondazione Toscana G. Monasterio-Ospedale del Cuore; 🇮🇹 Massa, Italy

Policlinico San Donato; 🇮🇹 Milano, Italy

A.O.U. Pisana; 🇮🇹 Pisa, Italy

San Raffaele Hospital; 🇮🇹 Milano, Italy

Universitätsklinikum Bonn; 🇩🇪 Bonn, Nordrhein-Westfalen, Germany

Hygea; 🇬🇷 Athens, Greece