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Observational, retrospective registry with acute and chronic endpoints
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant of the device for Cardiac Contractility Modulation (CCM) Therapy | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of QoL | 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. | 12 months |
| Reduction of HF Hospitalizations and Emergency Ward accesses | 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 | 12 months |
| Improvement of Fuctional Capacity | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess of HF biomarkers trends | Assess of HF biomarkers trends (laminine, NT-ProBNP, copeptine) during the FU compared to baseline | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with standard indication to CCM therapy device implantation with Cardiolaminopahy aetiology and in HF status.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio D'Onofrio, MD | Contact | +39 0817062605 | donofrioant1@gmail.com | |
| Giuliano D'Alterio, MD | Contact | +39 0817062605 | gdalterio@libero.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonio D'Onofrio, MD | Ao dei Colli - Monaldi Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AO dei Colli - Monaldi Hospital | Recruiting | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D000083083 | Laminopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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