NCT03714412

Brief Summary

The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

October 7, 2018

Last Update Submit

April 29, 2019

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Freedom from major device- or procedure- related serious adverse events

    Evaluate the safety of the Cardiovalve with its associated procedure

    30 days

Secondary Outcomes (7)

  • Technical success of delivery and deployment of the device

    Intraoperative

  • Freedom from emergency surgery or reintervention

    30 days

  • Freedom from rehospitalizations or reinterventions due to the underlying condition

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

  • Reduction in MR grade

    30 days, 3-, 6-, 12 and 24-months

  • NYHA class

    30 days, 3-, 6-, 12 and 24-months

  • +2 more secondary outcomes

Study Arms (1)

Implantation

EXPERIMENTAL

Eligible patients will undergo implantation with the Cardiovalve system

Device: Implantation

Interventions

ImplantationDEVICE

Implantation of the Cardiovalve transfemoral mitral valve replacement system

Also known as: Cardiovalve
Implantation

Eligibility Criteria

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

You may qualify if:

  • \. NYHA functional II, III or ambulatory IV 3. Severe mitral regurgitation (MR grade 3-4+) with pronounced secondary MR etiology 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). 7. 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.

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
  • 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
  • Left atrial or LV thrombus or vegetation
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hygeia Hospital

Athens, Greece

Location

Silesian Center for Heart Diseases

Zabrze, 41-800, Poland

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases
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

October 7, 2018

First Posted

October 22, 2018

Study Start

September 1, 2019

Primary Completion

December 15, 2019

Study Completion

December 15, 2023

Last Updated

May 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)PL(1)