Not yet recruiting NCT07256678
Jewel P-WCD Post-Approval Study (PAS)
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 →
Unsure about the terms? Read our patient guide →
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