NCT01966146

Brief Summary

Aim of the study is the definition of criteria for a standardized assessment of heart function by 3D echocardiographic procedures. Standardized criteria will be defined to assess aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 21, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

1.4 years

First QC Date

July 17, 2013

Last Update Submit

December 1, 2014

Conditions

Development of Standardized Assessment TAVI and MitraClip Procedures by EchocardiographyAortic StenosisMitral Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures

    Analysis will be performed after heart valve replacement or reconstruction procedures and after 6 month

Study Arms (2)

TAVI

EXPERIMENTAL

Echocardiography after TAVI

Device: Echography GE Healthcare Vivid E9

MitraClip

EXPERIMENTAL

Echocardiography after MitraClip procedure

Device: Echography GE Healthcare Vivid E9

Interventions

Echography GE Healthcare Vivid E9DEVICE

Echography GE Healthcare Vivid E9

MitraClipTAVI

Eligibility Criteria

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

You may qualify if:

  • patients with severe symptoms of an aortic stenosis who underwent catheter based implantation of an aortic valve
  • patients who are planned to undergo a reconstruction of the mitral valve with the MitraClip System
  • Patients who are aged above 18 years and legally competent
  • signed informed consent

You may not qualify if:

  • patients with previous myocard infarction, previous heart surgeries, malignity or valvular abnormities \> stage 1
  • patients with atrial fibrillation
  • pregnant and breast-feeding women
  • patients with disturbed central nerve system
  • patients with pacemaker, implants, ferrous clamps,insulin pump
  • patients with tattoo
  • patients with claustrophobia
  • patiens with asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Aortic Valve StenosisMitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

October 21, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

DE(1)