ArcticLine Feasibility Study

Medtronic Cardiac Ablation Solutions

Status: Completed

Conditions: Atrial Flutter; Atrial Fibrillation

Treatments: Device: ArcticLine Cardiac Cryoablation Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT03604263

MDT16015

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

• Hypertrophic cardiomyopathy with LV septal wall thickness >1.5 cm

• Uncontrolled hyperthyroidism

• Thrombocytosis, thrombocytopenia (including history of heparin-induced thrombocytopenia)

• Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate

• History of blood clotting or bleeding abnormalities

• Contraindication to all anticoagulation (e.g. novel oral anticoagulants, heparin or warfarin)

• Pregnant, nursing or planning to become pregnant during study duration

• Enrollment in another clinical trial without prior approval from Medtronic

• Presence or use of left atrial appendage closure device

• Presence of or planned implantation of a pacemaker, implantable cardiac defibrillator, implantable loop recorder or cardiac resynchronization device with permanent lead placement

• Pre-existing hemidiaphragmatic paralysis

• Life expectancy less than one year

• Known drug or alcohol dependency

• Existing pulmonary vein stent(s)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter

Treatment:

Device: ArcticLine Cardiac Cryoablation Catheter