Trial Outcomes & Findings for ArcticLine Feasibility Study (NCT NCT03604263)
NCT ID: NCT03604263
Last Updated: 2025-02-13
Results Overview
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
COMPLETED
NA
17 participants
7 days
2025-02-13
Participant Flow
Participant milestones
| Measure |
Treatment Arm
Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter
ArcticLine Cardiac Cryoablation Catheter: Cryoablation
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ArcticLine Feasibility Study
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=15 Participants
Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter
ArcticLine Cardiac Cryoablation Catheter: Cryoablation
|
|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Baseline BMI
|
31.6 kg/meter-squared
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Baseline Systolic Blood Pressure
|
145.1 mmHg
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Baseline Diastolic Blood Pressure
|
81.8 mmHg
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Heart Rate
|
74.7 beats/min
STANDARD_DEVIATION 19.2 • n=5 Participants
|
|
LVEF (%)
|
56.3 percentage of ejected blood
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Left Atrial Diameter (mm)
|
44.7 mm
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
NYHA Class
Class I
|
4 Participants
n=5 Participants
|
|
NYHA Class
Class II
|
2 Participants
n=5 Participants
|
|
NYHA Class
Subject Does Not Have Heart Failure
|
9 Participants
n=5 Participants
|
|
Time from Initial AF Diagnosis (months)
|
97.6 months
STANDARD_DEVIATION 68.6 • n=5 Participants
|
|
Months of Continuous AF
|
1.8 months
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Time from First Documented Persistent AF
|
18.7 months
STANDARD_DEVIATION 20.2 • n=5 Participants
|
|
Number of Failed AADs
|
1.9 drugs
STANDARD_DEVIATION 1.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysA 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
Outcome measures
| Measure |
Treatment Arm
n=15 Participants
Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter
ArcticLine Cardiac Cryoablation Catheter: Cryoablation
|
|---|---|
|
Number of Participants With Primary Safety Events With an Onset Date Within 7 Days Post-procedure.
|
0 Participants
|
Adverse Events
Treatment Arm
Serious adverse events
| Measure |
Treatment Arm
n=15 participants at risk
Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter
ArcticLine Cardiac Cryoablation Catheter: Cryoablation
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
20.0%
3/15 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Anal Fissure
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.7%
1/15 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Treatment Arm
n=15 participants at risk
Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter
ArcticLine Cardiac Cryoablation Catheter: Cryoablation
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
26.7%
4/15 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Anxiety Disorder
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Cardiac disorders
Atrial Flutter
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
General disorders
Chest Discomfort
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Investigations
Heart Rate Irregular
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
General disorders
Oedema Peripheral
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
General disorders
Peripheral Swelling
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
1/15 • Number of events 1 • 6 months
|
|
Cardiac disorders
Ventricular Extrasystoles
|
6.7%
1/15 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place