Heart Failure, Systolic
Conditions
Keywords
Heart Failure, Quality of Life, Cardiac Contractility Modulation
Brief summary
Observational and perspective study with acute and chronic endpoint.
Detailed description
This registry includes patients who have undergone implantation of the cardiac contractility modulation device due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, as indicated in the guidelines of the ESC of 2016 and the Expert Consensus Document of the ESC Heart Failure group published in May 2019 for to assess the benefits after the CCM device.
Interventions
DEVICEDevice for Cardiac Contractility Modulation Therapy (CCM)
Evaluate the effect from CCM Therapy in HF population
Sponsors
Monaldi Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or non-pregnant female, aged 18 or older; * chronic heart failure with symptomatic left ventricular systolic function; (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker); * Appropriate and optimized medical therapy * Patient signed and dated informed consent form at enrollment; * life expectancy\> 1 year due to the absence of comorbidities that reduce the prognosis
Exclusion criteria
* absence of venous access available for implant; * contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale); * pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement Quality of Life | 12 months | Evaluatation of the impact on CCM Therapy on Quality of Life evaluated from the reduction of MLWHFQ score at FU post implant of CCM device compared to baseline |
| Functional Capacity | 12 months | Evaluation of the impact on CCM Therapy on Functional Capacity evaluated from the gain of distance traveled in the 6MWT at FU post implant of CCM device compared to baseline |
| Reduction of HF Hospitalizations and Emergency Ward accesses | 12 months | Reduction of HF Hospitalizations and Emergency Ward accesses at FU post implant of CCM device compared to number of HF hospitalization an Emergency Ward accesses collected 1 year before the implant of CCM therapy |
Countries
Italy
Contacts
Primary ContactAntonio D'Onofrio, MD
Backup ContactGiuliano D'Alterio, MD
Outcome results
None listed