Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL, United Kingdom
Location contact
Neil Srinivasan
CONTACT
NCT Number: NCT06384599
The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Basildon, Essex, SS16 5NL, United Kingdom
Neil Srinivasan
CONTACT
This VT Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical VT Cryoablation System in real world clinical settings.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console)
Time frame: 6 months
Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period
Time frame: 30 Days
Freedom from device / procedure related major adverse events (MAE) during and after the ablation procedure through 30 days follow up. MAEs include:
Time frame: During the procedure
Analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryotherapy ablation procedure.
Time frame: 6 months
Freedom from serious adverse events at 6M following discharge.
Contact information is provided by the study sponsor or research team.
Doug Kurschinski
CONTACT
Nabil Jubran
CONTACT
Adagio Medical
Industry
Adagio Medical VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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