Clinical trial NCT01956526: CORolla™ TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diastolic Heart Failure NYHA Class III-IV
Diastolic Dysfunction Secondary to Aortic Stenosis
Keywords: Heart Failure with Preserved Ejection Fraction (HFpEF)
Diastolic Heart Failure (DHF)
Diastolic Dysfunction (DD)
Lead sponsor: CorAssist Cadiovascular Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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".


Eligibility criteria: 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

Primary outcomes:
measure: Cardiovasculare related SAEs
timeFrame: 12 month post surgery
Secondary outcomes:
measure: feasibility
timeFrame: up to 36 month post surgery
measure: Feasibility
timeFrame: up to 36 month post surgery
measure: Feasibility
timeFrame: up to 36 month post surgery
measure: Feasibility
timeFrame: Up to 36 month post surgery
measure: Feasibility
timeFrame: up to 36 month post surgery
measure: Feasibility
timeFrame: up to 36 month post surgery
measure: Feasibility
timeFrame: up to 36 month post surgery
Other outcomes:
measure: Procedural success
timeFrame: intra procedural
Locations:
city: Brescia
country: Italy
facility: Spedali Civili - Brescia Hospital
city: Milan
country: Italy
facility: Multimedica
Study officials:
References:
citation: Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg 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. No abstract available.
citation: Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbely 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. doi: 10.1093/eurheartj/ehm037. Epub 2007 Apr 11.