Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-24 @ 12:54 PM
NCT ID:
NCT01723761
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01723761
Study Brief:
Protocol Section:
NCT01723761