ArcticLine Feasibility Study

NCT03604263 | Completed Results FDA Device

• 1 other identifier: MDT16015
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter

Device: ArcticLine Cardiac Cryoablation Catheter

Interventions

ArcticLine Cardiac Cryoablation Catheter DEVICE

Cryoablation

Also known as: Arctic Front Advance Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Catheter, FlexCath Advance Steerable Sheath

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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%

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (4)

BayCare Medical Group Cardiology

Tampa, Florida, 33607, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Krestyn Thomas
• Organization: Medtronic CRHF

krestyn.j.thomas@medtronic.com

6123236613

Study Officials

• Frank Pelosi, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: October 18, 2018
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: February 13, 2025
• Results First Posted: May 20, 2020

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (1)