Diastolic Dysfunction Secondary to Aortic Stenosis Clinical Trial
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".
| Status | Recruiting |
| Enrollment | 12 |
| Est. completion date | September 2017 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Spedali Civili - Brescia Hospital | Brescia | |
| Italy | Multimedica | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| CorAssist Cadiovascular Ltd. |
Italy,
Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Strömberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. Review. Erratum in: Eur Heart J. 2010 Apr;12(4):416. Dosage error in article text. Eur Heart J. 2010 Mar;31(5):624. Dosage error in article text. — View Citation
Paulus WJ, Tschöpe C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbély A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007 Oct;28(20):2539-50. Epub 2007 Apr 11. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Procedural success | Success of the implant surgical procedure will be determined according to Implantation Rating Questionnaire. | intra procedural | No |
| Primary | Cardiovasculare related SAEs | 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 | Yes |
| Secondary | feasibility | Change in Quality of Life (QoL): Minnesota Living with Heart Failure. | up to 36 month post surgery | No |
| Secondary | Feasibility | Change in NYHA f. class | up to 36 month post surgery | No |
| Secondary | Feasibility | Change in exercise capacity as measured by the Six-Minute Walk test | up to 36 month post surgery | No |
| Secondary | Feasibility | Composite rate of HF death and re-hospitalization at 6 months and 1 year. | Up to 36 month post surgery | No |
| Secondary | Feasibility | 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 | No |
| Secondary | Feasibility | 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 | No |
| Secondary | Feasibility | Changes in cardiac medical therapy including daily diuretic dose | up to 36 month post surgery | No |