VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
NCT ID: NCT06384599
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
130 participants
INTERVENTIONAL
2024-06-01
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VT Cryoablation Arm
all subjects will receive a cryoablation procedure with the VT System and be followed up for 6-month
VT Cryoablation System
All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console)
Interventions
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VT Cryoablation System
All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console)
Eligibility Criteria
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Inclusion Criteria
* IC 2 Planned ablation procedure according to the indication for use of the Adagio VT Cryoablation System
* IC 3 Subject willing to comply with study requirements and give informed consent
* IC4 Subject has or will be receiving an ICD prior to hospital discharge
Exclusion Criteria
* EC 2 Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor
* EC 3 Any other condition that, in the judgement of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than six months, extensive travel away from the research center)
18 Years
ALL
No
Sponsors
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Adagio Medical
INDUSTRY
Responsible Party
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Locations
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Essex Cardiothoracic Centre
Basildon, Essex, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Neil Srinivasan
Role: primary
Other Identifiers
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CS-190
Identifier Type: -
Identifier Source: org_study_id
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