A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)

A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02478008

Enrollment

Registered

2015-06-23

Start date

2015-06-30

Completion date

2015-08-31

Last updated

2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Heart Disease, Heart Valve Disease, Mitral Insufficiency

Keywords

Transcatheter Mitral Valve Replacement, Mitral Regurgitation, Mitral Insufficiency, Transapical

Brief summary

The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.

Interventions

DEVICECardiAQ TMVI System (Transapical DS)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * NYHA Classification ≥ III * Left Ventricular Ejection Fraction ≥ 30% * Mitral regurgitation ≥ Grade 3+ * Subject meets anatomical eligibility criteria for the investigational device

Design outcomes

Primary

Measure	Time frame
Composite Major Adverse Event Rate	30-Day

Countries

Denmark, France, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026