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

NCT01347125 | Terminated Early Phase 1 DMC

• 1 other identifier: CLD 0201
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

DHF (diastolic heart failure); HFNEF (heart failure with normal ejection fraction

Outcome Measures

Primary Outcomes (1)

• Safety: Adverse event reporting

  Adverse event reporting will continue up to 36 month follow up. Any complication attributed to the device will be recorded. Any Major Adverse Cardiac Event (MACE) will be evaluated in a safety committee composed from company representative and a cardiosurgeon which is not part of the company

  36 month

Secondary Outcomes (1)

• Functionality - Successful Device implantation

  Immediately post implantation day

Study Arms (2)

ImCardia

EXPERIMENTAL

Aortic Stenosis patients candidates for Aortic Valve Replacement (AVR) implanted with the ImCardia device

Device: ImCardia Device

AVR control group

NO INTERVENTION

Aortic stenosis patients candidates for aortic valve replacement

Interventions

ImCardia Device 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

Also known as: IMC 01

ImCardia

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female able to understand and sign a informed consent
• Be 50 years of age or older
• NYHA class III, IV
• EF \>55%
• Candidates for aortic valve replacement due to aortic stenosis.
• Agrees to attend all follow- up evaluations

You may not qualify if:

• Free wall thickness less than11.5mm
• Adhesions are expected from a previous surgery or medical condition (e.g. s/p chest radiation therapy etc.)
• Presence of significant myocardial scars (e.g. postinfarction) at proposed site for implant of ImCardia™device Attachment screw.
• Likely to be need CABG following the implantation of the ImCardia™
• Intra-cardiac thrombus/mass
• Myocarditis
• Acute/chronic pericarditis
• Not a candidate for sternotomy
• Active infection
• Stroke, surgery or ICD within 3 months
• Acute coronary syndrome during the past 6 months
• Left ventricular regional wall motion abnormalities
• Significant valvular disease other that aortic stenosis
• Significant pulmonary disease
• A history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the Principal Investigator

Sponsors & Collaborators

• CorAssist Cadiovascular Ltd.: lead

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Lea Lak, M.D.

  CorAssist Cardiovascular

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 4, 2011
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2012
• Last Updated: May 4, 2011

Record last verified: 2011-05