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

NCT03339115 | Active Not Recruiting DMC

• 1 other identifier: CP 17-02
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 11

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.

Conditions

Mitral Regurgitation; Mitral Valve Disease

Keywords

Mitral Insufficiency; Heart Failure; Mitral Valve; Heart Diseases; Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

• The primary safety endpoint is freedom from all-cause mortality and major adverse events

  Freedom from all-cause mortality, all cause hospitalization, major adverse cardiac events (MACE), major device- or procedure- related serious adverse events

  30 days, 3 Months, 6 Months, 12 Months, and 24 Months

Secondary Outcomes (4)

• Technical success

  Intraoperative, 30 Days

• Device Success

  Intraoperative

• Device Success

  30 days, 3 Months, 6 Months, 12 Months, and 24 Months

• Patient Success

  30 days, 3 Months, 6 Months, 12 Months, and 24 Months

Study Arms (1)

Cardiovalve Transfemoral Mitral Valve

EXPERIMENTAL

Mitral replacement valve delivered through a transfemoral access and transseptal approach

Device: Cardiovalve Transfemoral Mitral Valve

Interventions

Cardiovalve Transfemoral Mitral Valve DEVICE

The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.

Cardiovalve Transfemoral Mitral Valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• NYHA functional II, III or ambulatory IV
• Severe mitral regurgitation (MR grade 3-4+)
• Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated.
• Elevated risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities.
• Able to undergo Transesophageal Echocardiography (TEE).
• Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
• The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
• Suitable for femoral access procedure and trans septal catheterization
• Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve (as assessed by the independent Screening Committee)

You may not qualify if:

• Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
• Acute myocardial infarction within the previous 30 days
• Any prior heart valve surgery or transcatheter mitral intervention
• Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
• Rheumatic heart disease or endocarditis within the previous 3 months
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
• Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
• Untreated clinically significant coronary artery disease requiring revascularization
• Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
• Aortic or pulmonic valve disease requiring surgery
• CRT/ICD implant within 30 days
• Left Ventricular Ejection Fraction (LVEF) \<30%
• LV end diastolic diameter \> 70mm
• Significant abnormalities of the mitral valve and sub-valvular apparatus.
• Severe mitral annular or leaflets calcification

Sponsors & Collaborators

• Cardiovalve Ltd.: lead
• Meditrial Europe Ltd.: collaborator
• Meditrial SrL: collaborator

Study Sites (11)

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Herzzentrum der Uniklinik Köln

Cologne, Germany

Location

Studienzentrale der Medizinische Klinik II Universitäres Herzzentrum Lübeck

Lübeck, Germany

Location

Universitaet_Mainz

Mainz, Germany

Location

Klinikum der Universität München LMU

München, Germany

Location

Hygea

Athens, Greece

Location

Maria Cecilia Hospital

Cotignola, Italy

Location

Fondazione Toscana G. Monasterio-Ospedale del Cuore

Massa, 54100, Italy

Location

San Raffaele Hospital

Milan, 20129, Italy

Location

Policlinico San Donato

Milan, Italy

Location

A.O.U. Pisana

Pisa, 56126, Italy

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Failure; Heart Diseases; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Georg Nickenig

  Bonn Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 13, 2017
• Study Start: April 23, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); IT (5); DE (5)