Heart Failure, Lamin A/C Gene Mutation, Laminopathy
Conditions
Keywords
Heart Failure, Cardiac Contyractility Modulation, Quality of Life
Brief summary
Observational, retrospective registry with acute and chronic endpoints
Detailed description
This registry includes patients who have undergone CCM device implant and due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, with LMNA-DCM etiology for to assess the impact on CCM therapy in term of improvemente of QoL and reduction HF hospitalizations
Interventions
DEVICEImplant of the device for Cardiac Contractility Modulation (CCM) Therapy
The intervention is an implant of CCM therapy devices and it is similar to conventional dual chamber cardiac devices with only difference of to insert n 2 leads fixed in right ventricular septum
Sponsors
Monaldi Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 of QoL | 12 months | Evaluation of the effect of CCM therapy on Quality of Life evaluated from the reduction of MLWHFQ score 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 collected during the FU post implant of CCM device compared to number of Hospitalizations and Emergenncy Ward accesses collected 1 year before the implant of CCM therapy device |
| Improvement of Fuctional Capacity | 12 months | Evaluation of the impact of CCM therapy on Functional Capacity evaluated from the gain of the distance travelled in the 6MWT at FU post implant of CCM therapy device compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess of HF biomarkers trends | 12 months | Assess of HF biomarkers trends (laminine, NT-ProBNP, copeptine) during the FU compared to baseline |
Countries
Italy
Contacts
Primary ContactAntonio D'Onofrio, MD
Backup ContactGiuliano D'Alterio, MD
Outcome results
None listed