NCT02515539

Brief Summary

The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high risk for mortality and morbidity from conventional open-heart surgery.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Status
withdrawn

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

August 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

March 31, 2016

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

August 3, 2015

Last Update Submit

March 29, 2016

Conditions

Mitral InsufficiencyHeart Valve DiseaseCardiovascular DiseaseHeart Disease

Keywords

Transcatheter Mitral Valve ReplacementMitral RegurgitationMitral InsufficiencyTransapicalTransfemoral

Outcome Measures

Primary Outcomes (1)

  • Composite Major Adverse Event Rate

    30-Day

Study Arms (1)

CardiAQ TMVI System (Transapical & Transfemoral DS)

EXPERIMENTAL

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Device: CardiAQ TMVI System (Transapical & Transfemoral DS)

Interventions

CardiAQ TMVI System (Transapical & Transfemoral DS)DEVICE

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

CardiAQ TMVI System (Transapical & Transfemoral DS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • See Protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Valve DiseasesCardiovascular DiseasesHeart Diseases

Study Officials

  • Wilson Szeto, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Howard Herrmann, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Saibal Kar, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

  • Alfredo Trento, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR
0

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

August 3, 2015

First Posted

August 4, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

July 1, 2021

Last Updated

March 31, 2016

Record last verified: 2015-08