A Prospective, Multicenter Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation

Adagio Medical3 sites in 3 countries80 target enrollmentJuly 2016

ConditionsAtrial Fibrillation Atrial Flutter

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Adagio Medical
Enrollment: 80
Locations: 3
Primary Endpoint: Technical performance assessed by complete electrical isolation of all pulmonary veins (entrance block).
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

March 31, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Adagio Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is diagnosed with paroxysmal (PAF), persistent, or long standing persistent atrial fibrillation (PsAF) for which an ablation procedure was deemed most appropriate therapy. Paroxysmal AF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven (7) days. Persistent AF is defined as: an episode lasting longer than seven (7) days, but less than one (1) year documented by consecutive ECG recordings of 100% AF greater than seven (7) days apart or an episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording. Long-Standing Persistent AF is defined as continuous AF that lasts longer than one (1) year.
•Reported incidence of at least one (1) documented episode of symptomatic atrial fibrillation (AF) during the twelve months preceding trial entry (should be documented by rhythm strip or ECG).
•Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation \[class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)\] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation, or intolerable side effects due to AAD.
•Left atrial size \<55 mm in largest dimension as measured and image documented by preoperative imaging (CT, MRI and/or TTE)
•Left Ventricular Ejection Fraction ≥ 40% (obtained within 12 months prior to the procedure).
•Anticoagulation therapy: patient is receiving anticoagulation therapy four (4) weeks prior to the ablation procedure (where appropriate) according to 2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation.
•Patient is at least 18 and ≤80 years of age.
•Patient is able and willing to comply with mandatory pre and post follow-up testing.
•Patient is able and willing to give informed consent.

Exclusion Criteria

•Patient had any previous left atrial ablation.
•History of any valvular cardiac surgical procedure, atrial septal defect closure device; or left atrial appendage closure device.
•Coronary artery bypass grafting (CABG) procedure within the last 3 months.
•Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
•Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) performed within 48 hours of the procedure if deemed appropriate by the investigator.
•History of a documented thromboembolic event within the past one (1) year.
•Diagnosed atrial myxoma.
•Patient has defibrillator implant.
•Patient has known cryoglobulinemia.
•Patient has any contraindication for oral anticoagulation.

Outcomes

Primary Outcomes

Technical performance assessed by complete electrical isolation of all pulmonary veins (entrance block).

Time Frame: 1 day

Technical performance assessed by complete linear block of linear lesions if deployed

Time Frame: 1 day

The primary safety endpoint will be determined by evaluating the incidence of serious adverse events > 30 days after the procedure

Time Frame: 12 months

Technical performance assessed by AF termination targeting driver regions, when applicable

Time Frame: 1 day

The primary safety endpoint will be determined by evaluating the incidence of procedural adverse events.

Time Frame: 1 day

The primary safety endpoint will be determined by evaluating the incidence of serious adverse events > 7 days after the procedure

Time Frame: 30 days

The primary safety endpoint will be determined by evaluating the incidence of serious adverse events within 7 days of procedure

Time Frame: 7 days

Secondary Outcomes

Performance assessed by total procedure times)(1 day)
Performance assessed by procedural fluoroscopy times(1 day)
Performance assessed by ablation times(1 day)
Performance assessed by complete freedom from documented AF or other atrial tachycardia (>30s), using a Holter monitor at 6-, 9-, and 12 months post ablation, after a single procedure and off AAD (following a 3 month blanking period).(12 months)
Performance assessed by percentage of RF focal ablation (touch up) to reach the primary performance endpoint.(1 day)