NCT02478008

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
4 countries

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

March 31, 2016

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

June 17, 2015

Last Update Submit

March 29, 2016

Conditions

Mitral InsufficiencyHeart Valve DiseaseCardiovascular DiseaseHeart Disease

Keywords

Transcatheter Mitral Valve ReplacementMitral RegurgitationMitral InsufficiencyTransapical

Outcome Measures

Primary Outcomes (2)

  • Composite Major Adverse Event Rate

    30-Day

  • Composite Major Adverse Event Rate

    12-Month

Study Arms (1)

CardiAQ TMVI System (Transapical DS)

EXPERIMENTAL
Device: CardiAQ TMVI System (Transapical DS)

Interventions

CardiAQ TMVI System (Transapical DS)DEVICE
CardiAQ TMVI System (Transapical DS)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Rigshospitalet University Hospital

Copenhagen, Denmark

Location

Centre hospitalier régional universitaire de Lille

Lille, France

Location

Hôpital Européen Georges-Pompidou

Paris, France

Location

Centre Hospitalier Universiatier de Toulouse

Toulouse, France

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

New Cross Hospital Heart Center

Wolverhampton, United Kingdom

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Valve DiseasesCardiovascular DiseasesHeart Diseases

Study Officials

  • Lars Søndergaard, MD, DMSc

    Rigshospitalet University Hospital (Copenhagen, Denmark)

    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

June 17, 2015

First Posted

June 23, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

March 31, 2016

Record last verified: 2015-09

Locations

FR(3)GB(2)DK(1)NL(3)