NCT01573091

Cardiac Resynchronization Therapy Modular Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Giuseppe Ricciardi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Cardiac Resynchronization Therapy	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

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-04-06
• Last updated: 2017-02-24

Locations

12 sites across 1 country: Italy