Clinical Trials Logo
  1. Home
  2. Cardiovascular Disease
  3. NCT02478008
  4. Details
NCT02478008 Clinical Trial

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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02478008
Other study ID # CIP-3102-01
Secondary ID
Status Recruiting
Phase N/A
First received June 17, 2015
Last updated September 9, 2015
Start date June 2015

Study information
Verified date September 2015
Source CardiAQ Valve Technologies, Inc.
Contact Paul Cornelison
Phone 949.537.3842
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines AuthorityFrance: Agence Nationale de Sécurité du Médicament et des produits de santéNetherlands: Ministry of Health, Welfare and SportUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Key Inclusion Criteria:

- NYHA Classification = III

- Left Ventricular Ejection Fraction = 30%

- Mitral regurgitation = Grade 3+

- Subject meets anatomical eligibility criteria for the investigational device

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• CardiAQ TMVI System (Transapical DS)

Locations
Country Name City State
Denmark Rigshospitalet University Hospital Copenhagen
France Centre hospitalier régional universitaire de Lille Lille
France Hôpital Européen Georges-Pompidou Paris
France Centre Hospitalier Universiatier de Toulouse Toulouse
Netherlands Medisch Centrum Leeuwarden Leeuwarden
Netherlands St. Antonius Ziekenhuis Nieuwegein
Netherlands Erasmus University Medical Center Rotterdam
United Kingdom Leeds General Infirmary Leeds
United Kingdom New Cross Hospital Heart Center Wolverhampton

Sponsors (1)
Lead Sponsor Collaborator
CardiAQ Valve Technologies, Inc.

Countries where clinical trial is conducted

Denmark,  France,  Netherlands,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite Major Adverse Event Rate 30-Day Yes
Primary Composite Major Adverse Event Rate 12-Month Yes
See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Completed NCT02502812 - Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects Phase 1
Recruiting NCT04216342 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers Phase 1
Completed NCT03654313 - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus Phase 1
Completed NCT03646656 - Heart Health Buddies: Peer Support to Decrease CVD Risk N/A
Completed NCT02081066 - Identification of CETP as a Marker of Atherosclerosis N/A
Completed NCT02147626 - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia N/A
Recruiting NCT03095261 - Incentives in Cardiac Rehabilitation N/A
Completed NCT02589769 - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A
Completed NCT02711878 - Healing Hearts and Mending Minds in Older Adults Living With HIV N/A
Completed NCT02868710 - Individual Variability to Aerobic Exercise Training N/A
Completed NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL N/A
Recruiting NCT02885792 - Coronary Artery Disease in Patients Suffering From Schizophrenia N/A
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Completed NCT02272946 - Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk Phase 2
Completed NCT02657382 - Mental Stress Ischemia: Biofeedback Study N/A
Completed NCT02640859 - Investigation of Metabolic Risk in Korean Adults
Recruiting NCT02265250 - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Active, not recruiting NCT02600338 - Meta-analyses of the Effect of Legumes on Blood Pressure N/A