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

Atrial Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355106
• Other study ID #: CS-001
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: May 21, 2019

Study information

• Verified date: December 2017
• Source: Adagio Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 21, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Device:
• PolarStart System
Atrial flutter Ablation

Locations

Country	Name	City	State
Belgium	OLV Hospital	Aalst
Netherlands	St. Antonius Hospital	Nieuwegein,

Sponsors (1)

Lead Sponsor	Collaborator
Adagio Medical

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by the percentage of subjects experiencing cardiovascular specific adverse events (CSAE) within thirty 30 days of the ablation procedure.		30 DAYS
Secondary	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.		30 minutes
Secondary	Outcome success	Percent of subjects with absence of AFl at 30 days (30 day ECG and as reported by subject or holter monitor)	30 days