Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)

B

Biotronik

Status

Terminated

Conditions

Cardiac Pacing
Electric Countershock
Ventricular Tachyarrhythmia

Treatments

Device: Standard implantable cardioverter defibrillator
Device: Implantable cardioverter defibrillator with Home Monitoring function

Study type

Interventional

Funder types

Industry

Identifiers

NCT00858559
HS047

Details and patient eligibility

About

Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are uneventful, revealing no relevant changes related to the implanted device and in the patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up intervals are frequently used although they are not according to recommendations. This may increase the delay in detection of relevant changes in the disease and in deviations from optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet platform accessible by the attending physician. In the present study, the investigators evaluate safety and efficacy of 12-month follow-up intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month follow-up scheme.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Indication for a single-chamber implantable cardioverter-defibrillator (ICD)

Exclusion criteria

  • Contraindication for ICD
  • Indication for dual-chamber ICD or cardiac resynchronization therapy

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 2 patient groups

1
Experimental group
Description:
Home Monitoring
Treatment:
Device: Implantable cardioverter defibrillator with Home Monitoring function
2
Active Comparator group
Description:
Home Monitoring not used
Treatment:
Device: Standard implantable cardioverter defibrillator

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems