ArcticLine Feasibility Study

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Atrial Flutter
• Intervention / Treatment: Device: ArcticLine Cardiac Cryoablation Catheter

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

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Montreal Heart Institute
• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • BayCare Medical Group Cardiology
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center (UPMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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 Arm; Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter	Device: ArcticLine Cardiac Cryoablation Catheter; Cryoablation; Other Names: Arctic Front Advance Cardiac Cryoablation Catheter; Freezor MAX Cardiac Cryoablation Catheter; FlexCath Advance Steerable Sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Primary Safety Events With an Onset Date Within 7 Days Post-procedure.	A primary safety event is defined as: An ArcticLine Catheter-related or ArcticLine cryoablation procedure-related SAE with an onset date within 7 days post-procedure (except as noted below), as adjudicated by the Clinical Events Committee (CEC), described as follows: Atrioesophageal fistula** Includes atrioesophageal fistula with an onset date at any time after the study cryoablation procedure and is adjudicated by the CEC as either ArcticLine Catheter-related or ArcticLine cryoablation procedure-related.; Cardiac perforation/tamponade; Cerebrovascular accident; Death; Esophageal injury; Major bleeding; Myocardial infarction; Pericarditis; Phrenic nerve injury (ongoing at hospital discharge); Transient ischemic attack; Vagal nerve injury resulting in esophageal dysmotility or gastroparesis; Vascular access complications	7 days

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Frank Pelosi, M.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): November 18, 2019
• Study Completion (Actual): November 18, 2019

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: MDT16015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes