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

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Flutter
• Intervention / Treatment: Device: PolarStart System

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • OLV Hospital
• Netherlands
  • Nieuwegein,, Netherlands
    • St. Antonius Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Atrial flutter Ablation	Device: PolarStart System; Atrial flutter Ablation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Adagio Medical

Publications and helpful links

General Publications

• Klaver MN, De Potter TJR, Iliodromitis K, Babkin A, Cabrita D, Fabbricatore D, Boersma LVA. Ultralow temperature cryoablation using near-critical nitrogen for cavotricuspid isthmus-ablation, first-in-human results. J Cardiovasc Electrophysiol. 2021 Aug;32(8):2025-2032. doi: 10.1111/jce.15142. Epub 2021 Jul 9.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 21, 2019

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Actual): May 22, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: CS-001