ArcticLine Feasibility Study

Completed · Not applicable

Conditions studied: Atrial Fibrillation, Atrial Flutter

In brief

The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.

Key facts

Study ID

NCT03604263

Run by

Medtronic Cardiac Ablation Solutions

People needed

17

Starts

2018-10-18

Expected to finish

2019-11-18

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documentation of symptomatic persistent AF:
• Defined as having a continuous episode that is sustained beyond 7 days documented via consecutive ECG recordings, or
• Defined as having a continuous episode that is sustained beyond 7 days documented by an ECG recording and one doctor note indicating the patient had symptoms consistent with AF
• Age 18 through 80 years old
• Failure or intolerance of at least one Class I or III antiarrhythmic drug
• Subject is able and willing to consent to participate in the study and will commit to completion of all follow-up requirements

You may not qualify if…

• Longstanding persistent AF, defined as continuous AF greater than 12 month duration
• Left atrial diameter greater than 5.0 cm
• Active systemic infection
• History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
• Prior left atrial ablation attempt, with exception of:
• Any pulmonary vein isolation attempt to treat AF, or
• Successful ablation to treat Wolff-Parkinson White syndrome
• History of left atrial tachycardia
• History of cardiac ablation within 90 days of planned clinical study procedure
• Planned concomitant ventricular ablation
• Cryoglobulinemia
• Structural heart disease of clinical significance including:
• NYHA Class IV Heart Failure
• Diagnosed with NYHA Class III Heart Failure for more than six months at time of the study ablation procedure
• LVEF less than 35%
• Any cardiac surgery (e.g. CABG) within 3 months of the ablation procedure
• Any mechanical heart valve, prior aortic or tricuspid valve replacement (e.g. valvotomy, valve replacement), or tricuspid valve repair
• Severe mitral valve regurgitation or stenosis
• Significant congenital anomaly or anatomy unable to accommodate device
• Prior surgical maze procedure
• Unstable angina
• Myocardial infarction within 3 months of the ablation procedure
• Presence of primum or secundum atrial septal defect
• Anomalous pulmonary venous return
• Prior surgery for congenital heart disease, including atrial septal defect repair

Where it is running

• BayCare Medical Group Cardiology — Tampa, Florida, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
• Montreal Heart Institute — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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