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CORolla™ TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction

NCT01956526 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-10-08

No results posted yet for this study

Summary

The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two treatment groups, "CORolla™ Stand-alone group" and " AVR \& CORolla™ Add on group".

Conditions

  • Diastolic Heart Failure NYHA Class III-IV
  • Diastolic Dysfunction Secondary to Aortic Stenosis

Interventions

DEVICE

CORolla™ TAA device

Sponsors & Collaborators

  • CorAssist Cadiovascular Ltd.

    lead INDUSTRY

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-09-30
Completion
2017-09-30

Countries

  • Italy

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 NCT01956526 on ClinicalTrials.gov