REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology

Last updated: December 15, 2021
Sponsor: Federico II University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Hyponatremia

Chest Pain

Treatment

N/A

Clinical Study ID

NCT05175937
137/21
  • Ages > 18
  • All Genders

Study Summary

The objective of this observational study is to assess clinical benefits of innovative features (e.g. Bluetooth technology and smartphone patient applications) in a patient population that is implanted with standard indication for implantable cardiac defibrillator.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients implanted with an ICD as for standard indications
  • Over 18 years of age
  • Ability to provide informed consent for registry participation and be willing and ableto comply with the protocol described evaluations

Exclusion

Exclusion Criteria:

  • Subject who is, or is expected to be inaccessible for follow-up
  • pregnancy

Study Design

Total Participants: 1104
Study Start date:
September 22, 2021
Estimated Completion Date:
April 01, 2025

Study Description

REACTION is an observational study in which patients will be followed as for clinical practice and no specific study tests/procedures will be perfprmed. After implanting a device, the patient will be assigned to an arm or to the other based on the technology of the device (bluetooth or RF) he/she wears, if he/she gives the consent to partecipate. It is not a randomized study. Patients will be enrolled consecutively until reaching the sample defined for both the arms.

Connect with a study center

  • Prof Antonio Rapacciuolo,MD, PhD

    Naples, 80128
    Italy

    Active - Recruiting

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