Status:
ACTIVE_NOT_RECRUITING
Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.
Lead Sponsor:
Biotronik SE & Co. KG
Collaborating Sponsors:
Irmandade Santa Casa de Misericórdia de Porto Alegre
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Brief Summary
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication...
Detailed Description
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication...
Eligibility Criteria
Inclusion
- Indication for implanting of a single chamber ICD (primary or secondary prevention) according to current guidelines;
- Sustained sinus rhythm as the current prevalent atrial rhythm;
- Planned de novo implantation with a BIOTRONIK single chamber DX ICD system;
- Patient is able to understand the nature of study and to provide written informed consent;
- Patient is willing and able to perform all follow up visits at the study site;
- Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Exclusion
- Age \< 18 years
- Any limitation to contractual capability;
- Female patients who are pregnant or breast feeding or planning pregnancy during the course of the study;
- Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment;
- Life expectancy \< 2 years;
- Patient is participating in any other interventional clinical investigation.
Key Trial Info
Start Date :
October 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04869527
Start Date
October 5 2021
End Date
April 30 2025
Last Update
October 15 2024
Active Locations (2)
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1
Santa Casa de Misericórdia de Porto Alegre - Brugada Institute
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
2
BIOTRONIK Coml Médica LTDA
São Paulo, Brazil, 01533-000