NCT03003481

Brief Summary

Collect patient data and to monitor the clinical use (safety and efficacy) of the device

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

4.6 years

First QC Date

October 24, 2016

Last Update Submit

April 13, 2022

Conditions

Mitral Paravalvular Leaks (PVL)Aortic Paravalvular Leaks (PVL)

Outcome Measures

Primary Outcomes (2)

  • Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.

    6 month following implantation

  • Absence of device -and/or procedure-related Serious Adverse Events (SAEs) including deaths, stroke (ischemic stroke that occurs within 24 hours following implantation), systemic embolism or device embolizations.

    6 month following implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with aortic or mitral PVL

You may qualify if:

  • \- Patients with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically significant heart failure

You may not qualify if:

  • The device is contraindicated for patients known to have any of the following:
  • Known coagulation dysfunction
  • Leak reversal with separate or significant residual or recurrent leak
  • Acute infection
  • Known intra-cardiac thrombi
  • Recent pelvic venous thrombosis
  • Recent myocardial infarction or a surgical bypass operation in the last 30 days
  • If adequate oral anticoagulation therapy / antiplatelet aggregation inhibition is not possible post-procedurally
  • Intolerance of contrast agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department

Bergamo, 24125, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

December 28, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

IT(1)