ArcticLine Feasibility Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-18

Study Completion Date

2019-11-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation

NCT01803438

Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases

COMPLETED PHASE4

Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System

NCT01687036

Atrial Fibrillation

COMPLETED NA

Assess Differences in Pain Following Cryo and Radiofrequency Atrial Fibrillation Ablation

NCT03148392

Atrial Fibrillation

UNKNOWN

Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation

NCT01645917

Paroxysmal Atrial Fibrillation

COMPLETED PHASE4

Arrhythmia Cohort Study

NCT07123896

Arrhythmia

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Atrial Flutter

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Arm

Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter

Group Type EXPERIMENTAL

ArcticLine Cardiac Cryoablation Catheter

Intervention Type DEVICE

Cryoablation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ArcticLine Cardiac Cryoablation Catheter

Cryoablation

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Arctic Front Advance Cardiac Cryoablation Catheter Freezor MAX Cardiac Cryoablation Catheter FlexCath Advance Steerable Sheath

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No