Cardiac Resynchronization Therapy Modular Registry (CRT-MORE)

Giuseppe Ricciardi

Status: Completed

Conditions: Heart Failure

Treatments: Procedure: Cardiac Resynchronization Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT01573091

2011/0043537

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Heart failure patients

Description:

Patients with a CRT device according to current guidelines

Treatment:

Procedure: Cardiac Resynchronization Therapy