Atrial FibrillationNCT03604263
ArcticLine Feasibility Study
A study testing ArcticLine Cardiac Cryoablation Catheter in people with Atrial Fibrillation and Atrial Flutter, run by Medtronic Cardiac Ablation Solutions at 4 sites in 2 countries.
Trial summary
The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- ArcticLine Cardiac Cryoablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 18 Oct 2018to 18 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
BayCare Medical Group Cardiology
Tampa, Florida, 33607
About this study
The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- ArcticLine Cardiac Cryoablation Catheter
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArcticLine Cardiac Cryoablation CatheterDevice
Also called Arctic Front Advance Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Catheter, FlexCath Advance Steerable Sheath
Cryoablation
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter Receives: Device: ArcticLine Cardiac Cryoablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start18 Oct 2018
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Pelosi, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604263
- Sponsor's protocol ID
- MDT16015
- Status last verified
- Feb 2025
- First submitted
- 19 Jul 2018
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ArcticLine Feasibility Study
- ClinicalTrials.gov ID
- NCT03604263
- Acronym / sponsor ID
- MDT16015
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Posted 20 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: ArcticLine Cardiac Cryoablation CatheterSubjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documentation of symptomatic persistent 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
Key exclusion criteria (39 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArcticLine Cardiac Cryoablation CatheterAlso: Arctic Front Advance Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Catheter, FlexCath Advance Steerable SheathCryoablation | Device | Treatment Arm |
Primary outcome
Number of Participants With Primary Safety Events With an Onset Date Within 7 Days Post-procedure.
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Pelosi, M.D. principal investigator
University of Michigan
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArcticLine Cardiac Cryoablation Catheter in people with Atrial Fibrillation and Atrial Flutter, run by Medtronic Cardiac Ablation Solutions at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Primary Safety Events With an Onset Date Within 7 Days Post-procedure. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.