NCT02079129

Brief Summary

The study objective is to assess the agreement between cMRI PVL grading (based on regurgitant fraction) and TTE PVL grading (based on pressure half-time and the ratio of the jet arc to the circumference of the annulus).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

4.5 years

First QC Date

March 3, 2014

Last Update Submit

January 19, 2020

Conditions

Paravalvular LeakTranscatheter Valve Replacement

Keywords

agreement between cMRI PVL grading and TTE PVL gradingEdwards Sapien TAVR

Outcome Measures

Primary Outcomes (1)

  • Assess the agreement between cMRI PVL grading (based on regurgitant fraction) and TTE PVL grading (based on pressure half-time and the ratio of the jet arc to the circumference of the annulus).

    Up to 1 year +/- 60 days post TAVR.

Eligibility Criteria

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

The study cohort will consist of 50 patients who have undergone Edwards Sapien TAVR who meet the following eligibility criteria and have provided written informed consent.

You may qualify if:

  • Patients aged ≥18 years
  • Patients eligible for implantation of Edwards Sapien aortic valve.

You may not qualify if:

  • Pregnancy-Women of childbearing potential should have negative urine pregnancy test prior to enrollment
  • Patients with implanted pacemaker
  • Patients with implantable cardiac defibrillator
  • Patients with contraindication to MRI
  • Medically unable to provide consent
  • Any surgical prosthesis
  • Moderate or severe mitral regurgitation
  • Central aortic valve leak

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Heart Hospital Baylor

Plano, Texas, 75093, United States

Location

Study Officials

  • Deepika Gopal, MD

    Baylor Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

US(1)