Prospective, Multicenter, Investigation of the Adagio Cryoablation System in Subjects With Atrial Flutter

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02355106
• Date of registration: 27/01/2015
• Prospective Registration: No
• Primary sponsor: Adagio Medical
• Public title: Prospective, Multicenter, Investigation of the Adagio Cryoablation System in Subjects With Atrial Flutter
• Scientific title: A Prospective, Multicenter, Investigation of the Adagio PolarStar System in Subjects With Atrial Flutter
• Date of first enrolment: January 2015
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02355106
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium, Netherlands

Key inclusion & exclusion criteria

Inclusion Criteria:

- Two symptomatic episodes of typical AFl (or chronic atrial flutter) during the
one-year period prior to enrollment. This may include typical AFl occurring while
receiving anti-arrhythmic drug (AAD) therapy for non-AFl tachyarrhythmia, including
atrial fibrillation (AF).

- At least one episode of typical (clockwise or counterclockwise) atrial flutter
documented by 12 lead electrocardiogram (ECG) within 6 months prior to enrollment.

- Subject has been diagnosed with symptomatic AFl

- Subject is at least 18 and =75 years of age.

- Subject is able and willing to give informed consent

Exclusion Criteria:

- Intra-cardiac thrombus has not been eliminated in subjects exposed to less than 4
weeks of therapeutic anticoagulation and a TEE (trans-esophageal echocardiogram)
and/or CT did not conclusively rule out thrombus

- Subject developed persistent AF at least once in history (electrical or
pharmacological cardioversion after 48h or episode duration >7 days).

Subject had any previous left atrial ablation.

- Subject had any previous cardiac surgery, e.g. prosthetic valves, except in the case
of an isolated coronary bypass surgery performed more than three months prior to the
procedure.

- Subject has permanent pacemaker or defibrillator implant.

- Subject has 2° type II, 3° degree atrioventricular (AV) block or left/right bundle
branch block pattern

- Subject has unstable angina pectoris.

- Subject has history of previous myocardial infarction (MI) or percutaneous
intervention during the last three months or planned in the next 3 months.

Subject has symptomatic carotid stenosis.

- Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension
or any other evidence of significant lung disease.

- Subject has any contraindication for oral anticoagulation.

- Subject has any history of previous transient ischemic attack (TIA) or stroke.

- Subject has known intra-cardiac thrombus formation.

- Subject has any significant congenital heart defect corrected or not (except for
patent foramen ovale that is allowed).

- Subject has evidence of congestive heart failure (NYHA class II, III or IV) in sinus
rhythm.

- Subject has hypertrophic cardiomyopathy.

- Subject has abnormal long or short QT interval, signs of Brugada syndrome, known
inheriting ion channel disease on the family, arrhythmogenic right ventricular
dysplasia.

- Subject has sarcoidosis.

- Subject has myxoma.

- Subject has thrombocytosis (platelet count > 600,000 / µl) or thrombocytopenia
(platelet count <100,000 / µl).

- Subject has any untreated or uncontrolled hyperthyroidism or hypothyroidism.

- Subject has renal dysfunction with glomerular filtration rate < 60 ml/min/1.72m2.

- Subject has a reversible causes for AF like alcoholism.

- Subject is a pregnant woman or woman of childbearing potential not on adequate birth
control: only woman with a highly effective method of contraception [oral
contraception or intra-uterine device] (who must have a negative pregnancy test within
1 week of randomization) or sterile woman can be enrolled.

- Subject is a breastfeeding woman.

- Subject has an active systemic infection.

- Subject is unwilling or unable to comply fully with study procedures and follow-up due
to any disease condition, which can raise doubt about compliance and influencing the
study outcome especially any kind of cancer requiring ongoing in-hospital treatment,
severe bleeding in history or a suspected pro-coagulant state.

- Legal incapacity or evidence that a subject cannot understand the purpose and risks of
the study or inability to comply fully with study procedures and follow up.

- Subject has a life expectancy of = 1 year.

- Subject is participating in any other clinical study



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Flutter

Intervention(s)

Device: PolarStart System

Primary Outcome(s)

Safety measured by the percentage of subjects experiencing cardiovascular specific adverse events (CSAE) within thirty 30 days of the ablation procedure. [Time Frame: 30 DAYS]

Secondary Outcome(s)

Acute Success measured by Percentage of subjects with termination of AFl and complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus at the end of the ablation procedure. [Time Frame: 30 minutes]

Outcome success [Time Frame: 30 days]

Secondary ID(s)

CS-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors