Cardiac Resynchronization Therapy Modular Registry

NCT ID: NCT01573091

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Heart failure patients

Patients with a CRT device according to current guidelines

Cardiac Resynchronization Therapy

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Giuseppe Ricciardi

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Ricciardi

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Luigi Padeletti, MD

Role: STUDY_CHAIR

Department of Heart and Vessels, University of Florence, Florence, Italy.

Locations

Ospedale Degli Infermi

Biella, Biella, Italy

San Giacomo e Cristoforo

Massa, Massa, Italy

Azienda Ospedaliera di Padova

Padua, Padova, Italy

Azienda Ospedaliera San Salvatore

Pesaro, Pesaro, Italy

Cardiovascular Department, Electrophysiology Unit, Istituto Ospedaliero Fondazione Poliambulanza

Brescia, , Italy

Department of Heart and Vessels, University of Florence

Florence, , Italy

Department of Cardiology and Coronary Care Unit, Azienda Ospedaliera S. Antonio Abate

Gallarate, , Italy

Department of Cardio, Thoracic and Vascular, Azienda Ospedaliera Carlo Poma

Mantova, , Italy

Department of Heart, Electrophysiology, Clinica Mediterranea

Naples, , Italy

Azienda Ospedale dei Colli - Monaldi

Napoli, , Italy

Policlinico Federico II

Napoli, , Italy

Department of Cardiology, Ospedale Civile "Misericordia e Dolce"

Prato, , Italy

Countries

Italy

References

Bertaglia E, Reggiani A, Palmisano P, D'Onofrio A, De Simone A, Caico SI, Pecora D, Arena G, Marini M, Ricciardi G, Badolati S, Spotti A, Solimene F, Ferraro A, Migliore F, Botto GL, Malacrida M, Stabile G. The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines reliably exclude patients with a worse prognosis in comparison with the 2013 ESC indication criteria. Int J Cardiol. 2018 Dec 15;273:162-167. doi: 10.1016/j.ijcard.2018.09.027. Epub 2018 Sep 8.

Reference Type: DERIVED

PMID: 30217421 (View on PubMed)

Stabile G, Pepi P, Palmisano P, D'Onofrio A, De Simone A, Caico SI, Pecora D, Rapacciuolo A, Arena G, Marini M, Pieragnoli P, Badolati S, Savarese G, Maglia G, Iuliano A, Botto GL, Malacrida M, Bertaglia E. Adherence to 2016 European Society of Cardiology guidelines predicts outcome in a large real-world population of heart failure patients requiring cardiac resynchronization therapy. Heart Rhythm. 2018 Nov;15(11):1675-1682. doi: 10.1016/j.hrthm.2018.04.011. Epub 2018 Apr 14.

Reference Type: DERIVED

PMID: 29665405 (View on PubMed)

Stabile G, D'Onofrio A, Pepi P, De Simone A, Santamaria M, Caico SI, Rapacciuolo A, Padeletti L, Pecora D, Giovannini T, Arena G, Spotti A, Iuliano A, Bertaglia E, Malacrida M, Botto GL. Interlead anatomic and electrical distance predict outcome in CRT patients. Heart Rhythm. 2015 Nov;12(11):2221-9. doi: 10.1016/j.hrthm.2015.05.020. Epub 2015 May 19.

Reference Type: DERIVED

PMID: 26001509 (View on PubMed)

Other Identifiers

2011/0043537

Identifier Type: -

Identifier Source: org_study_id