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Rule Out Transcatheter Aortic Valve Thrombosis With Post Implantation Computed Tomography (RETORIC)

NCT02826200 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-01-18

No results posted yet for this study

Summary

The RETORIC study is a prospective cohort study with a primary aim to assess the incidence and independent predictors of reduced leaflet motion and valve thrombosis after TAVI procedure using multimodality imaging strategy comprising cardiac CT, transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). As a secondary aim we will assess the incidence of stroke and transient ischemic attack (TIA) in patients with reduced leaflet motion and/or thrombosis when compared with those with normal leaflet function. In addition we will randomize patients with reduced leaflet motion and/or valve thrombosis to single antiplatelet therapy plus oral anticoagulation therapy versus standard therapy.

The primary outcome of the nested randomized trial will be the presence of reduced leaflet motion and/or valve thrombosis after 4 months, the secondary outcome is the presence of ischemic changes in brain demonstrated by MRI.

Conditions

  • Prosthetic Cardiac Valve Thrombosis
  • Cerebrovascular Accident
  • Prosthetic Valve Malfunction

Interventions

DRUG

Acenocoumarol

Standard of care plus oral anticoagulant therapy (acenocoumarol)

OTHER

Standard of care

Standard of care

Sponsors & Collaborators

  • Semmelweis University Heart and Vascular Center

    lead OTHER

Principal Investigators

  • Béla Merkely, MD, PhD, DSc · Semmelweis University Heart and Vascular Center

  • Pál Maurovich-Horvat, MD, PhD, MPH · Semmelweis University Heart and Vascular Center

  • Ronak Rajani, MD MRCP BM · Guy's and St Thomas' NHS Foundation Trust, Kings College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-07-31
Completion
2019-01-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02826200 on ClinicalTrials.gov