Status:
UNKNOWN
Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection
Lead Sponsor:
Trialance SCCL
Conditions:
Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
Eligibility:
All Genders
18+ years
Brief Summary
Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection
Detailed Description
Prospective, randomized, open-label, multicenter, international study in a population with an accepted indication for an implantable automatic defibrillator. The main objective is to know the differe...
Eligibility Criteria
Inclusion
- Patients with an indication of a single chamber ICD due to high risk of sudden death.
- Patients with and without a prior history of AF.
- Patients with indication for primary and secondary prevention.
- Device optimized for the discrimination of supraventricular events.
- DX device implant with single floating cable.
- Activation of "Home Monitoring" function.
- Over 18 years.
- Signature of informed consent
Exclusion
- Indication for permanent atrial pacing according to current pacing guidelines.
- Congestive heart failure grade IV.
- Candidates for Cardiac Resynchronization Therapy.
- Patients with a previous device.
- Permanent Atrial Fibrillation.
- Life expectancy less than 12 months.
- Pregnant or lactating women.
- Patients who are unable to understand the nature of the study.
- Subjects with irreversible brain damage caused by pre-existing brain disease.
- Heart transplant 6 months prior to recruitment or expected in the next 3 months.
- Cardiac surgery 3 months prior to recruitment or planned for the next 3 months.
Key Trial Info
Start Date :
November 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT04344704
Start Date
November 2 2018
End Date
March 1 2023
Last Update
April 14 2020
Active Locations (16)
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1
Hospital Universitario Clínico de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
2
Hospital Universitario de Araba
Vitoria-Gasteiz, Alava, Spain, 01009
3
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
4
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907