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ImCardia for DHF to Treat Diastolic Heart Failure (DHF) Patient a Pilot Study

NCT01347125 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2011-05-04

No results posted yet for this study

Summary

This study is designed to evaluate the ImCardia safety and to demonstrate system functionality in patients undergoing AV replacement with respect to 36 months follow up.

Conditions

  • Heart Failure With Normal Ejection Fraction

Interventions

DEVICE

ImCardia Device

The device operates by harnessing energy expended by the left ventricle (LV) during Systole and returning it to the heart during Diastole thereby making it available to augment diastolic performance

Sponsors & Collaborators

  • CorAssist Cadiovascular Ltd.

    lead INDUSTRY

Principal Investigators

  • Lea Lak, M.D. · CorAssist Cardiovascular

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-04-30
Completion
2012-05-31

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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 NCT01347125 on ClinicalTrials.gov