Cardiac Resynchronization Therapy Modular Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

Detailed Description
-----------------
Heart failure is a complex clinical syndrome characterized by a high prevalence and incidence in populations at greatest risk and, therefore, with a significant social and economic impact. Randomized clinical trials, meta-analyzes, observational studies and controlled trials clearly demonstrated that the neuro-hormonal therapy is highly effective in reducing mortality, hospitalization and improving quality of life. In recent years the electrical therapy is playing an increasingly important role in the treatment of patients with chronic heart failure. Such importance is mainly due to the possibility of preventing sudden cardiac death by implanting an ICD and to correct the deleterious effects of electrical dyssynchrony and / or left ventricular mechanics by CRT. The CRT has proven an effective tool in reducing mortality, reducing symptoms and improving quality of life in patients already receiving optimal medical therapy. Despite the undoubted benefits that the electrical treatment has added to conventional medical therapy, a high percentage of patients does not benefit in terms of clinical and echocardiographic. The identification of non-responders to CRT is crucial in order not to submit the patients to an unnecessary and costly device whose electrical therapy proves to be ineffective. The reason for lack of response is still unclear but factors such as lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

Official Title
-----------------
Cardiac Resynchronization Therapy Modular Registry

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Procedure: Cardiac Resynchronization Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic symptomatic HF despite stable, optimal drug therapy Indication for a cardiac resynchronisation device with or without defibrillator backup according to current guidelines Patients implanted with cardiac resynchronization device Exclusion Criteria: Patients participating in other studies that clearly impact the clinical practice of the center Patients who are unable to provide informed consent Patients who can not perform follow-up in the center

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart failure patients<br>Patients with a CRT device according to current guidelines | Procedure: Cardiac Resynchronization Therapy<br>* Any commercially available Cardiac Resynchronization Therapy devices with or without defibrillation backup (CRT-D/CRT-P) can be used upon discretion of the investigator according to current guidelines<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Improvement in functional class status by at least one NYHA Class or remain in functional class II | 24 months | 
| Echocardiographic response of absolute increase of ≥5% in LVEF | Patients at follow-up to 6-12 months show an increase of the absolute value of the LVEF than 5% | 24 months | 
| Echocardiographic response of ≥15% reduction in LVESV | Patients at follow-up to 6-12 months show a systolic volume (LVESV) reduction greater than 15% | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV lead/RV lead geometric distance | To investigate the correlation of LV lead/RV lead geometric distance (as measured by fluoroscopy) and reverse remodeling in cardiac resynchronization therapy (as measured by echocardiography as defined in primary outcome measure) at 12 months. The relation with LVESVi change between baseline and 12 months will be analyzed. | 12 months | 
| Change from baseline in R wave in 12-lead ECG at 12 months | To investigate the relationship between the ECG characteristics at baseline and response to cardiac resynchronization therapy (as measured by echocardiography as defined in primary outcome measure) at 12 months. The purpose of this objective is to evaluate the R wave in 12-lead ECG during BIV, RV and LV pacing and change from baseline at 12 months. | 12 months | 
| Number of ventricular arrhythmias after cardiac resynchronization therapy | To investigate the relationship between LV pacing and the number of ventricular tachycardia/fibrillation and/or appropriate/inappropriate shocks. The number and type of arrhythmia before and after upgrading to CRT device at 24 months will be analyzed | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac resynchronization therapy, Heart failure