Cardiac Resynchronization Therapy Modular Registry (CRT-MORE)

February 22, 2017 updated by: Giuseppe Ricciardi
The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Biella, Italy, 61679
        • Ospedale Degli Infermi
      • Brescia, Italy, 25124
        • Cardiovascular Department, Electrophysiology Unit, Istituto Ospedaliero Fondazione Poliambulanza
      • Florence, Italy, 50134
        • Department of Heart and Vessels, University of Florence
      • Gallarate, Italy, 21013
        • Department of Cardiology and Coronary Care Unit, Azienda Ospedaliera S. Antonio Abate
      • Mantova, Italy, 46100
        • Department of Cardio, Thoracic and Vascular, Azienda Ospedaliera Carlo Poma
      • Massa, Italy, 54100
        • San Giacomo e Cristoforo
      • Naples, Italy, 80122
        • Department of Heart, Electrophysiology, Clinica Mediterranea
      • Napoli, Italy, 80131
        • Azienda Ospedale dei Colli - Monaldi
      • Napoli, Italy
        • Policlinico Federico II
      • Padova, Italy, 61353
        • Azienda Ospedaliera di Padova
      • Pesaro, Italy, 61998
        • Azienda Ospedaliera San Salvatore
      • Prato, Italy, 59100
        • Department of Cardiology, Ospedale Civile "Misericordia e Dolce"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients eligible for CRT device implanted according to current guidelines

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: 24 months
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
Time Frame: 24 months
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
Time Frame: 24 months
Patients at follow-up to 6-12 months show a systolic volume (LVESV) reduction greater than 15%
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
LV lead/RV lead geometric distance
Time Frame: 12 months
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
Time Frame: 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
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Giuseppe Ricciardi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Luigi Padeletti, MD, Department of Heart and Vessels, University of Florence, Florence, Italy.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011/0043537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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