Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • VT Cryoablation System

    Device

    All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console)

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: VT Cryoablation ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Performance Endpoint

Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period

Time frame
6 months
2

Primary Safety Endpoint

Freedom from device / procedure related major adverse events (MAE) during and after the ablation procedure through 30 days follow up. MAEs include: * Death * MI * Cardiac perforation / pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion * Heart valve damage resulting in moderate to severe regurgitation * Access site complications requiring surgical intervention * Pericarditis * Heart block requiring a pacemaker implant * Other serious adverse device effects (SADEs).

Time frame
30 Days

Secondary outcomes

1

Secondary Performance Endpoint

Analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryotherapy ablation procedure.

Time frame
During the procedure
2

Secondary Safety Endpoint

Freedom from serious adverse events at 6M following discharge.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adagio Medical

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: