Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry

Study Overview
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Brief Summary
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Observational, retrospective registry with acute and chronic endpoints

Detailed Description
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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

Official Title
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Subanalysis in Patients With CARDIoLAMinopathy Enrolled to Retrospective and Observational Registy on Cardiac Contractility Modulation Therapy

Conditions
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Laminopathy, Lamin A/C Gene Mutation, Heart Failure

Intervention / Treatment
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* Device: Implant of the device for Cardiac Contractility Modulation (CCM) Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implant 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Cardiac Contyractility Modulation, Quality of Life