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Not yet recruiting NCT07256678

Jewel P-WCD Post-Approval Study (PAS)

Observational Jewel-P WCD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: This study is an observational registry study of the Jewel P-WCD in post-market use, Jewel.
Who it may be relevant to
Registry conditions: Jewel-P WCD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The objective of this PAS is to demonstrate the continued safety and clinical effectiveness of the Jewel P-WCD.

Detailed description

This study is an observational registry study of the Jewel P-WCD in post-market use

Interventions

  • Other This study is an observational registry study of the Jewel P-WCD in post-market use
    This study is an observational registry study of the Jewel P-WCD in post-market use
  • Other Jewel
    This study is an observational registry study of the Jewel P-WCD in post-market use

Primary outcome measures

  • Percent of VT/VF events successfully detected by the Jewel P-WCD [Time frame: From enrollment to the end of treatment at approximately 90 days]

Eligibility criteria

Inclusion criteria

  • N/A - registry will collect data already obtained commercially from patients prescribed the Jewel P-WCD.

Exclusion criteria

  • N/A - registry will collect data already obtained through commercial consent from patients prescribed the Jewel P-WCD

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07256678 · PR-3162

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗