Cardiac Resynchronization Therapy Modular Registry (CRT MORE)

This study is currently recruiting participants.
Verified July 2012 by University of Florence
Sponsor:
Information provided by (Responsible Party):
Giuseppe Ricciardi, University of Florence
ClinicalTrials.gov Identifier:
NCT01573091
First received: April 2, 2012
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Heart Failure
Procedure: Cardiac Resynchronization Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Resynchronization Therapy Modular Registry

Resource links provided by NLM:


Further study details as provided by University of Florence:

Primary Outcome Measures:
  • Clinical response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Improvement in functional class status by at least one NYHA Class or remain in functional class II

  • Echocardiographic response of absolute increase of ≥5% in LVEF [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patients at follow-up to 6-12 months show an increase of the absolute value of the LVEF than 5%

  • Echocardiographic response of ≥15% reduction in LVESV [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patients at follow-up to 6-12 months show a systolic volume (LVESV) reduction greater than 15%


Secondary Outcome Measures:
  • LV lead/RV lead geometric distance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in R wave in 12-lead ECG at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Number of ventricular arrhythmias after cardiac resynchronization therapy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 500
Study Start Date: December 2011
Groups/Cohorts Assigned Interventions
Heart failure patients
Patients with a CRT device according to current guidelines
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients eligible for CRT device implanted according to current guidelines

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573091

Locations
Italy
Cardiovascular Department, Electrophysiology Unit, Istituto Ospedaliero Fondazione Poliambulanza Recruiting
Brescia, Italy, 25124
Contact: Domenico Pecora, MD       domenico.pecora@poliambulanza.it   
Principal Investigator: Domenico Pecora, MD         
Department of Heart and Vessels, University of Florence Recruiting
Florence, Italy, 50134
Contact: Luigi Padeletti, MD       crtmore@gmail.com   
Contact: Giuseppe Ricciardi, MD       crtmore@gmail.com   
Principal Investigator: Luigi Padeletti, MD         
Department of Cardiology and Coronary Care Unit, Azienda Ospedaliera S. Antonio Abate Recruiting
Gallarate, Italy, 21013
Contact: Ivan Caico, MD       ivan.caico@aogallarate.it   
Principal Investigator: Ivan Caico, MD         
Department of Cardio, Thoracic and Vascular, Azienda Ospedaliera Carlo Poma Recruiting
Mantova, Italy, 46100
Contact: Albino Reggiani, MD       albinoreggiani545@hotmail.com   
Principal Investigator: Albino Reggiani, MD         
Principal Investigator: Patrizia Pepi, MD         
Principal Investigator: Andrea Droghetti, MD         
Department of Heart, Electrophysiology, Clinica Mediterranea Recruiting
Naples, Italy, 80122
Contact: Giuseppe Stabile, MD       gmrstabile@tin.it   
Principal Investigator: Giuseppe Stabile, MD         
Department of Cardiology, Ospedale Civile "Misericordia e Dolce" Recruiting
Prato, Italy, 59100
Contact: Tiziana Giovannini, MD       Tigiova59@libero.it   
Principal Investigator: Tiziana Giovannini, MD         
Sponsors and Collaborators
Giuseppe Ricciardi
Investigators
Study Chair: Luigi Padeletti, MD Department of Heart and Vessels, University of Florence, Florence, Italy.
  More Information

No publications provided

Responsible Party: Giuseppe Ricciardi, Principal Investigator, University of Florence
ClinicalTrials.gov Identifier: NCT01573091     History of Changes
Other Study ID Numbers: 2011/0043537
Study First Received: April 2, 2012
Last Updated: July 11, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Florence:
Cardiac resynchronization therapy
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014