ArcticLine Feasibility Study
Primary Purpose
Atrial Fibrillation, Atrial Flutter
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ArcticLine Cardiac Cryoablation Catheter
Sponsored by
About this trial
This is an interventional device feasibility trial for Atrial Fibrillation
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)
Sites / Locations
- BayCare Medical Group Cardiology
- University of Michigan
- University of Pittsburgh Medical Center (UPMC)
- Montreal Heart Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03604263
First Posted
July 19, 2018
Last Updated
May 8, 2020
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT03604263
Brief Title
ArcticLine Feasibility Study
Official Title
ArcticLine Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
November 18, 2019 (Actual)
Study Completion Date
November 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter
Intervention Type
Device
Intervention Name(s)
ArcticLine Cardiac Cryoablation Catheter
Other Intervention Name(s)
Arctic Front Advance Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Catheter, FlexCath Advance Steerable Sheath
Intervention Description
Cryoablation
Primary Outcome Measure Information:
Title
Number of Participants With Primary Safety Events With an Onset Date Within 7 Days Post-procedure.
Description
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
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Pelosi, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
BayCare Medical Group Cardiology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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ArcticLine Feasibility Study
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