VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
ConditionVentricular Tachycardia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdagio Medical
About this trial
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.
Eligibility criteria
Qualifiers
IC 1 Male or female the ages of ≥ 18 years
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
Disqualifiers
EC 1 In the opinion of the investigator, any known contraindication to a ventricular tachycardia procedure with the Adagio VT Cyroablation System as indicated in the device Instructions For Use (IFU)
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)
Trial design
Treatments tested in this trial
- VT Cryoablation System
Treatment groups
130 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov