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

October 7, 2013 updated by: CorAssist Cadiovascular Ltd.
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".

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • Spedali Civili - Brescia Hospital
        • Contact:
          • Claudio Muneretto, M.D. Prof.
          • Phone Number: 39 030 3996401
        • Contact:
          • Laura Tononi
        • Principal Investigator:
          • Claudio Muneretto, M.D. Prof.
      • Milan, Italy, 20099
        • Not yet recruiting
        • Multimedica
        • Contact:
          • Edoardo Gronda, M.D. Prof.
          • Phone Number: +39 0224209460
        • Principal Investigator:
          • Edoardo Gronda, M.D. Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical criteria

    • Adult (age > 18 years)
    • Diagnosis of heart failure with preserved systolic function according with ESC 2008 Guidelines (ejection fraction ≥ 50%)
    • NYHA F. Class III or IV symptoms with history of previous heart failure hospitalization in the last year
    • Able to sign informed consent and return for follow-up visits.
    • No contraindication for anticoagualation and antiplatelet treatment.
    • Cardiac medications unchanged for greater than 4 weeks (not including diuretics)
    • Pulmonary Wedge pressure > 15 mmHg documented by right heart catheterization at enrollment.

  • Echocardiographic criteria

    • Preserved regional wall motion (no wall motion abnormalities).
    • Left ventricular ejection fraction ≥ 50%
    • LV end-diastolic volume index (LVEDVI) <97 ml/m2.
    • Left Atrial Volume Index: (LAVi >29 ml/m2).
    • E/E' ratio ( mean of septal and lateral ) ≥12 (applicable only to patients with sinus rhythm)
    • No intra-cardiac thrombus.
    • Minimal endocardial height from Apex to Mitral Annulus ≥ 70mm.

Exclusion Criteria:

  • Cardiovascular disease

    • Uncontrolled HTN defined as > 140/90 mmHg, or >160/90 mmHg for patients on 3-drug therapy
    • Current or anticipated need for ICD, currently implanted with a cardiac resynchronization device (CRT), left ventricular assist device (LVAD).
    • Within the past 3 months - Acute myocardial infarction (AMI), cerebral vascular accident (CVA), Transient Ischemic Attack (TIA) , Percutaneous coronary intervention (PCI or transmyocardial laser revascularization (TMR or PMR)
    • Valvular disease (unless add - on to aortic valve replacement due to aortic stenosis)
    • Hypertrophic cardiomiopathy
    • Pericardial disease
    • Cor pulmonale or other cause of isolated right heart failure.
    • Non reversible pulmonary hypertension.
    • Right ventricle failure or right ventricular myocardial infarction.
    • Infiltrative heart disease

  • Non-cardiovascular disease

    • Non-cardiovascular condition limiting ability to assess the 6-minute hall walk test
    • Prior surgery, radiation, or thoracic surgery limiting the ability to place the device
    • Body mass index of greater than 40
    • Uncontrolled hyperglycemic status as addressed by HbA1c >8.5%
    • Asthma COPD (e.g. FEV1 <1.5 liter), or severe restrictive lung disease
    • Severe chronic renal failure indicated by MDRD GFR <30 mL/min/1.73 m2
    • Liver impairment addressed by bilirubin > 2 mg/dl and or pseudo- colinesterasis plasma concentration < 1500 IU and/or abnormal coagulative profile
    • Severe anemia addressed by Hb concentration <10 gr/l.
    • Solid organ or hematologic transplant.
    • Previous Trans Apical procedures/implantation

  • Miscellaneous conditions

    • Unwilling to fulfill the protocol medication compliance, testing, and follow-up requirements
    • Co-morbid condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements
    • Pregnancy at the time of enrollment. (Women of child bearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices)
    • Enrolled in another investigational study
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CORolla™ TAA Stand Alone
Single arm study design including with patients with isolated HFpEF, in NYHA f. Cl. III-IV. These patients will receive the CORolla™ TAA device. For assessments of results, intra-patient comparisons of pre-procedure and follow-up data will be performed;
Device: CORolla™ TAA device
Experimental: AVR and CORolla™ TAA Add On group
patients who require aortic valve replacement (AVR) due to aortic stenosis and have diastolic dysfunction will receive the CORolla™ TAA device.
Device: CORolla™ TAA device
No Intervention: AVR and CORolla ADD On - Control
patients who require only the aortic valve replacement (AVR) due to aortic stenosis and have diastolic dysfunction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovasculare related SAEs
Time Frame: 12 month post surgery

Investigational device safety with the intended study population with respect to 12 months follow up will be demonstrated using the following:

Cardiovascular mortality and morbidity reports at 30 days post surgery.

Serious adverse events: death, arrhythmia, CVA, AMI, bleeding and valve injury at 12 months post-surgery.
12 month post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility
Time Frame: up to 36 month post surgery
Change in Quality of Life (QoL): Minnesota Living with Heart Failure.
up to 36 month post surgery
Feasibility
Time Frame: up to 36 month post surgery
Change in NYHA f. class
up to 36 month post surgery
Feasibility
Time Frame: up to 36 month post surgery
Change in exercise capacity as measured by the Six-Minute Walk test
up to 36 month post surgery
Feasibility
Time Frame: Up to 36 month post surgery
Composite rate of HF death and re-hospitalization at 6 months and 1 year.
Up to 36 month post surgery
Feasibility
Time Frame: up to 36 month post surgery
Impact of CORolla™ TAA therapy on markers of diastolic dysfunction assessed by conventional echocardiography imaging (e.g LAVI index etc)and novel approach including Tissue Doppler Imaging (TDI)
up to 36 month post surgery
Feasibility
Time Frame: up to 36 month post surgery
Change of Wedge pressure - for safety assessment and impact of CORolla™ TAA therapy on this marker of diastolic dysfunction
up to 36 month post surgery
Feasibility
Time Frame: up to 36 month post surgery
Changes in cardiac medical therapy including daily diuretic dose
up to 36 month post surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: intra procedural
Success of the implant surgical procedure will be determined according to Implantation Rating Questionnaire.
intra procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CorAssist Cadiovascular Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 7, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLD CRL 0403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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