STOP Persistent AF

Description

To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation.

Study Start Date

March, 02 2017

Estimated Completion Date

July 2020

Interventions

  • Device: Arctic Front Advance Cardiac CryoAblation Catheter

Study ID

Medtronic Atrial Fibrillation Solutions -- STOP Persistent AF

Status

Recruiting

Trial ID

NCT03012841

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

225

Sponsor

Medtronic Atrial Fibrillation Solutions

Inclusion Criteria

  • Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings
  • Failure or intolerance of at least one Class I or III antiarrhythmic drug
  • Age 18 (or older if required by local law) to 80

Exclusion Criteria

  • Left atrial diameter > 5.0 cm (anteroposterior)
  • Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
  • Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
  • Body mass index (BMI) >40
  • Presence of any pulmonary vein stents
  • Presence of any pre-existing pulmonary vein stenosis
  • Pre-existing hemidiaphragmatic paralysis
  • Presence of any cardiac valve prosthesis
  • Moderate or severe mitral valve regurgitation or stenosis
  • Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the consent date
  • Unstable angina
  • NYHA Class IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) less than 45% measure by acceptable cardiac testing (e.g. TTE)
  • Primary pulmonary hypertension
  • Rheumatic heart disease
  • Thrombocytosis, thrombocytopenia
  • Any condition contraindicating chronic anticoagulation
  • Active systemic infection
  • Hypertrophic cardiomyopathy
  • Cryoglobulinemia
  • Uncontrolled hyperthyroidism
  • Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the consent date
  • Any woman known to be pregnant or breastfeeding, or any woman of child bearing potential who is not on a reliable form of birth regulation method or abstinence
  • Life expectancy less than one year
  • Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
  • Known allergies or hypersensitivities to adhesives
  • Known drug or alcohol dependency
  • Unwilling or unable to comply fully with study procedures and follow-up

Gender

All

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (46)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Jagmeet Singh MD 617-643-2887 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Jagmeet Singh MD 617-643-2887 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Jagmeet Singh MD 617-643-2887 None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Jagmeet Singh MD 617-643-2887 None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Alexandra ShadeSilver 212-824-8929 None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Alexandra ShadeSilver 212-824-8929 None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Alexandra ShadeSilver 212-824-8929 None
Icahn School of Medicine at Mount Sinai - New York, New York 183.2 miles Alexandra ShadeSilver 212-824-8929 None
Doylestown Health Cardiology - Doylestown, Pennsylvania 251.7 miles Linda Schwarz 267-893-9700 None
Doylestown Health Cardiology - Doylestown, Pennsylvania 251.7 miles Linda Schwarz 267-893-9700 None
Doylestown Health Cardiology - Doylestown, Pennsylvania 251.7 miles Linda Schwarz 267-893-9700 None
Asheville Cardiology Associates - Asheville, North Carolina 774.5 miles Olivia Lim 828-274-6000 None
Asheville Cardiology Associates - Asheville, North Carolina 774.5 miles Olivia Lim 828-274-6000 None
Asheville Cardiology Associates - Asheville, North Carolina 774.5 miles Olivia Lim 828-274-6000 None
Northwestern University - Chicago, Illinois 847.9 miles Albert Lin MD 312-695-1806 None
Northwestern University - Chicago, Illinois 847.9 miles Albert Lin MD 312-695-1806 None
Northwestern University - Chicago, Illinois 847.9 miles Albert Lin MD 312-695-1806 None
Northwestern University - Chicago, Illinois 847.9 miles Albert Lin MD 312-695-1806 None
Cardiac Arrhythmia Service - Boca Raton, Florida 1,221.1 miles E Martin Kloosterman MD 561-266-0190 None
Cardiac Arrhythmia Service - Boca Raton, Florida 1,221.1 miles E Martin Kloosterman MD 561-266-0190 None
Cardiac Arrhythmia Service - Boca Raton, Florida 1,221.1 miles E Martin Kloosterman MD 561-266-0190 None
Cardiac Arrhythmia Service - Boca Raton, Florida 1,221.1 miles E Martin Kloosterman MD 561-266-0190 None
St Lukes Health System - Kansas City, Missouri 1,250.3 miles Sanjaya Gupta MD 816-931-1883 None
St Lukes Health System - Kansas City, Missouri 1,250.3 miles Sanjaya Gupta MD 816-931-1883 None
St Lukes Health System - Kansas City, Missouri 1,250.3 miles Sanjaya Gupta MD 816-931-1883 None
St Lukes Health System - Kansas City, Missouri 1,250.3 miles Sanjaya Gupta MD 816-931-1883 None
Baylor Research Institute - Dallas, Texas 1,549.9 miles Peter Wells MD 214-820-7108 None
Baylor Research Institute - Dallas, Texas 1,549.9 miles Peter Wells MD 214-820-7108 None
Baylor Research Institute - Dallas, Texas 1,549.9 miles Peter Wells MD 214-820-7108 None
Baylor Research Institute - Dallas, Texas 1,549.9 miles Peter Wells MD 214-820-7108 None
Medical Center of the Rockies - Loveland, Colorado 1,759.6 miles Ethan Ellis MD 970-624-5296 None
Medical Center of the Rockies - Loveland, Colorado 1,759.6 miles Ethan Ellis MD 970-624-5296 None
Medical Center of the Rockies - Loveland, Colorado 1,759.6 miles Ethan Ellis MD 970-624-5296 None
Medical Center of the Rockies - Loveland, Colorado 1,759.6 miles Ethan Ellis MD 970-624-5296 None
Colorado Heart and Vascular - Lakewood, Colorado 1,777.0 miles J Thomas Svinarich MD 303-595-2619 None
Colorado Heart and Vascular - Lakewood, Colorado 1,777.0 miles J Thomas Svinarich MD 303-595-2619 None
Colorado Heart and Vascular - Lakewood, Colorado 1,777.0 miles J Thomas Svinarich MD 303-595-2619 None
Colorado Heart and Vascular - Lakewood, Colorado 1,777.0 miles J Thomas Svinarich MD 303-595-2619 None
Swedish Medical Center - Seattle, Washington 2,488.3 miles Darryl Wells MD 206-320-3917 None
Swedish Medical Center - Seattle, Washington 2,488.3 miles Darryl Wells MD 206-320-3917 None
Swedish Medical Center - Seattle, Washington 2,488.3 miles Darryl Wells MD 206-320-3917 None
Swedish Medical Center - Seattle, Washington 2,488.3 miles Darryl Wells MD 206-320-3917 None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Christopher Fellows MD 206-341-8907 None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Christopher Fellows MD 206-341-8907 None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Christopher Fellows MD 206-341-8907 None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Christopher Fellows MD 206-341-8907 None

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