ArcticLine Feasibility Study

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03604263
• Collaborator: (none)
• Enrollment: 17
• Locations: 4
• Arm: 1
• Actual Duration (Months): 13
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Atrial Flutter	Device: ArcticLine Cardiac Cryoablation Catheter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: ArcticLine Feasibility Study
• Actual Study Start Date: Oct 18, 2018
• Actual Primary Completion Date: Nov 18, 2019
• Actual Study Completion Date: Nov 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter	Device: ArcticLine Cardiac Cryoablation Catheter; Cryoablation; Other Names: Arctic Front Advance Cardiac Cryoablation Catheter Freezor MAX Cardiac Cryoablation Catheter FlexCath Advance Steerable Sheath

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Primary Safety Events With an Onset Date Within 7 Days Post-procedure. [7 days]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BayCare Medical Group Cardiology	Tampa	Florida	United States	33607
2	University of Michigan	Ann Arbor	Michigan	United States	48109
3	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania	United States	15213
4	Montreal Heart Institute	Montréal	Quebec	Canada

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: Frank Pelosi, M.D., University of Michigan

Study Documents (Full-Text)

• Statistical Analysis Plan - Sep 24, 2019
• Study Protocol: CIP version 1.0 - Jun 14, 2017
• Study Protocol: CIP version 3.0 - Mar 18, 2018
• Study Protocol: CIP version 4.0 - Jun 14, 2018
• Study Protocol: CIP version 5.0 - Apr 24, 2019

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT03604263
• Other Study ID Numbers: MDT16015
• First Posted: Jul 27, 2018
• Last Update Posted: May 20, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Atrial Fibrillation; Atrial Flutter

Study Results

Participant Flow

Arm/Group Title	Treatment Arm
Arm/Group Description	Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter ArcticLine Cardiac Cryoablation Catheter: Cryoablation
Period Title: Overall Study
STARTED	17
COMPLETED	15
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Treatment Arm
Arm/Group Description	Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter ArcticLine Cardiac Cryoablation Catheter: Cryoablation
Overall Participants	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.1 (6.3)
Sex: Female, Male (Count of Participants)
Female	2 13.3%
Male	13 86.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.7%
Not Hispanic or Latino	14 93.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	15 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Baseline BMI (kg/meter-squared) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/meter-squared]	31.6 (4.6)
Baseline Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	145.1 (12.4)
Baseline Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	81.8 (12.2)
Heart Rate (beats/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [beats/min]	74.7 (19.2)
LVEF (%) (percentage of ejected blood) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of ejected blood]	56.3 (8.1)
Left Atrial Diameter (mm) (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	44.7 (4.1)
NYHA Class (Count of Participants)
Class I	4 26.7%
Class II	2 13.3%
Subject Does Not Have Heart Failure	9 60%
Time from Initial AF Diagnosis (months) (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	97.6 (68.6)
Months of Continuous AF (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	1.8 (1.7)
Time from First Documented Persistent AF (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	18.7 (20.2)
Number of Failed AADs (drugs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [drugs]	1.9 (1.1)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Arm
Arm/Group Description	Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter ArcticLine Cardiac Cryoablation Catheter: Cryoablation
Measure Participants	15
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	6 months
Arm/Group Title	Treatment Arm
Arm/Group Description	Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter ArcticLine Cardiac Cryoablation Catheter: Cryoablation
All Cause Mortality
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	1/15 (6.7%)
Serious Adverse Events
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	6/15 (40%)
Cardiac disorders
Atrial Fibrillation	3/15 (20%)	3
Gastrointestinal disorders
Anal Fissure	1/15 (6.7%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/15 (6.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma	1/15 (6.7%)	1
Respiratory, thoracic and mediastinal disorders
Epistaxis	1/15 (6.7%)	1
Vascular disorders
Hypotension	1/15 (6.7%)	1
Other (Not Including Serious) Adverse Events
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	13/15 (86.7%)
Blood and lymphatic system disorders
Anaemia	1/15 (6.7%)	1
Cardiac disorders
Atrial Fibrillation	4/15 (26.7%)	5
Atrial Flutter	1/15 (6.7%)	1
Palpitations	1/15 (6.7%)	1
Ventricular Extrasystoles	1/15 (6.7%)	1
Gastrointestinal disorders
Abdominal Pain Upper	1/15 (6.7%)	1
Gastrointestinal Disorder	1/15 (6.7%)	1
General disorders
Chest Discomfort	1/15 (6.7%)	1
Fatigue	1/15 (6.7%)	1
Oedema Peripheral	1/15 (6.7%)	1
Peripheral Swelling	1/15 (6.7%)	1
Infections and infestations
Bronchitis	1/15 (6.7%)	1
Cellulitis	1/15 (6.7%)	1
Pneumonia	1/15 (6.7%)	1
Urinary Tract Infection	1/15 (6.7%)	1
Investigations
Heart Rate Irregular	1/15 (6.7%)	1
Musculoskeletal and connective tissue disorders
Pain in Extremity	1/15 (6.7%)	1
Nervous system disorders
Dizziness	1/15 (6.7%)	1
Psychiatric disorders
Anxiety Disorder	1/15 (6.7%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/15 (6.7%)	1
Throat Irritation	1/15 (6.7%)	1
Skin and subcutaneous tissue disorders
Ecchymosis	1/15 (6.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.