Cardiac Arrhythmias Clinical Trial
— ARIAOfficial title:
Correlations Between Arrhythmias, Climatic Variables and Air Pollution in Patients With Pacemaker and ICD, Followed by Remote Monitoring.
Verified date | July 2015 |
Source | Effect Group, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
It is a clinical, observational study to evaluate the correlations among arrhythmias,
climatic variables and air pollution in patients with pacemaker and implantable
defibrillator (ICD), followed by remote monitoring.
Purpose of the Study: The purpose of this study is to test the hypothesis that changes in
climatic variables, such as temperature, pressure and humidity, and changes of particulate
matter <10µ (PM10), particulate matter <2.5µ (PM2.5), ozone (O3), carbon monoxide (CO),
sulfur dioxide (SO2), nitrogen dioxide (NO2), are associated with an increase of
supraventricular and ventricular arrhythmias.
Objectives: The aim of this study is to determine whether changes in variables conditions
affect the electrical stability of the myocardium in patients with pacemakers and ICDs.
Population: male and female subjects, aged ≥ 18 years, implanted by a dual-chamber
pacemaker, ICD or biventricular ICD (ICD-CRT). A total of 500 subjects from 15 cardiology
centers of the Veneto region will be included.
Status | Completed |
Enrollment | 473 |
Est. completion date | June 2015 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Stable subjects,> 18 years, who have been implanted with a dual-chamber pacemaker, an ICD or ICD-CRT, compatible with remote monitoring systems, with daily transmission of data. Exclusion Criteria: - Presence of heart failure clinically manifest. - Concomitant illness or a significant condition which severely limits the life expectancy. - Any medical or surgical condition that, at the discretion of the investigator, places the patient at higher risk for his participation in the study. - History of malignancy of any organ system in the last two years, whether treated or untreated, including leukemia and lymphoma (with the exception of basal cell carcinoma of the skin) if there is evidence of local recurrence of metastasis. - History of drug or alcohol abuse in the last 2 years. - Participation in another study of a drug or device within 30 days after randomization. - Inability to communicate and to comply with all such obligations including the unwillingness or inability to give an informed consent. - Residence in urban centers without environmental monitoring. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale S.Maria dei Battuti - Cardiologia | Conegliano | |
Italy | Ospedale di ESte | Este | |
Italy | Mater Salutis | Legnago | |
Italy | Dell'Angelo Hospital | Mestre | |
Italy | Ospedale Civile | Mirano | |
Italy | Ospedale S. Valentino | Montebelluna | |
Italy | Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova | Padova | |
Italy | Civic Hospital | Portogruaro | |
Italy | Ospedale Ca' Foncello - Divisione di Cardiologia | Treviso |
Lead Sponsor | Collaborator |
---|---|
Effect Group, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of atrial arrhythmias. | The arrhythmic events that will occur during follow-up period, detected by remote monitoring or through other clinical evaluations, will be recorded and classified as follows: atrial fibrillation or atrial flutter, supraventricular tachycardia. | 12- 24 months. | No |
Primary | incidence of ventricular arrhythmias | The arrhythmic events that will occur during follow-up period, detected by remote monitoring or through other clinical evaluations, will be recorded and classified as follows: ventricular tachycardia, ventricular fibrillation, premature ventricular beats. | 12-24 months | No |
Secondary | Mean heart rate | Mean heart rate obtained by remote monitoring of pacemaker and ICDs. | 12-24 months | No |
Secondary | Heart rate variability | Measures of heart rate variability calculated by devices and obtained by remote monitoring. | 12-24 months | No |
Secondary | Percentage of paced beats | Percentage of paced beats will be measured by devices diagnostic and obtained via remote monitoring. | 12-24 months | No |
Secondary | Mortality for myocardial infarction or heart failure. | 12-24 months | No | |
Secondary | Hospitalization for myocardial infarction or heart failure. | 12-24 months | No |
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