Clinical trial NCT03604263: ArcticLine Feasibility Study
Official title: ArcticLine Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Primary Safety Events With an Onset Date Within 7 Days Post-procedure.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: BayCare Medical Group Cardiology
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: University of Michigan
name: Frank Pelosi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: