Paroxysmal Atrial FibrillationPhase 4SUPIRNCT01645917
Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation
A Phase 4 study testing Arctic Front Advance Cardiac CryoAblation system in people with Paroxysmal Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Czechia.
Trial summary
The purpose of the study is to determine the permanency of PV isolation with the Arctic Front Advance cryoablation system in paroxysmal AF patients. It will also provide data on acute procedural outcomes and measures as well as clinical AF recurrence in these patients approximately 3 months post-ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Arctic Front Advance Cardiac CryoAblation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCzechia
- Study dates
- Aug 2012to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years old
- Subject has been diagnosed with recurrent, symptomatic paroxysmal atrial fibrillation, documented as per institutional practice
- Left atrial diameter is no larger than 5.5cm
- Subject has failed one or more anti-arrhythmic drugs
- Subject is indicated for a pulmonary vein ablation using Arctic Front Advance
- Subject (or subject's legally authorized representative) is able and willing to give informed consent
Who cannot join
- Subject has persistent (>7 days) or permanent AF
- Subject has a left atrial thrombus detected on TEE
- Subject has had a prior left atrial ablation
- Subject has an intracardiac thrombus
- Subject is contraindicated for EP study
- Subject is unable to tolerate heparin or oral anti-coagulation
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- Subject has a cardiac valve prosthesis
- Subject has advanced structural heart disease, congenital heart disease (repaired or not), left ventricular ejection fraction (LVEF) <45%, coronary artery bypass graft within 3 months of the procedure
- Subject has presence of any pulmonary vein stents
- Subject has presence of any pre-existing pulmonary vein stenosis
- Subject has had a cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date
- Subject is a woman known to be pregnant, as documented in medical record
- Subject is unwilling or unable to comply fully with study procedures and follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SUstained PV Isolation With aRctic Front Advance
The purpose of the study is to determine the permanency of PV isolation with the Arctic Front Advance cryoablation system in paroxysmal AF patients. It will also provide data on acute procedural outcomes and measures as well as clinical AF recurrence in these patients approximately 3 months post-ablation.
Read the detailed description
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. It is estimated that more than 7 million people worldwide have the disease. Over the past decade, catheter ablation has become an accepted treatment for patients with AF. Ablation strategies that target the pulmonary vein are considered the cornerstone for treatment. The innovative Arctic Front cryoballoon is used for the treatment of drug refractory recurrent symptomatic paroxysmal AF (PAF). The system was designed to overcome many of the challenges of point-by-point catheter ablation by providing an anatomical approach for pulmonary vein isolation (PVI), creating long contiguous circumferential lesions surrounding the pulmonary vein. The cryoballoon system has a low risk of complications and proven efficacy in treating PAF.
AF recurrence rates have been reported up to 30% after initial ablation with PVI technologies including point-by-point RF catheter ablation. Arrhythmia recurrence can be caused by non-contiguous ablation lines that allow conduction gaps. Arctic Front Advance™ Cardiac CryoAblation Catheter (Arctic Front Advance), the second-generation cryoballoon which has recently been introduced following clearance by regulatory agencies in both the US and EU, is positioned to address this challenge with PVI technologies. The new catheter features the EvenCool™ Cryo Technology, which optimizes how the refrigerant is distributed inside the balloon, providing more uniform, distal cooling around the circumference of the balloon. The purpose of this study is to examine the rate of electrical PV isolation with the next generation system .
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Arctic Front Advance Cardiac CryoAblation system
- Keywords
- paroxysmal atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arctic Front Advance Cardiac CryoAblation systemDevice
Standard of care ablation for indicated paroxysmal AF patients with Medtronic's Arctic Front Advance Cardiac CryoAblation system
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Ablation with Arctic Front Advance Cardiac CryoAblation system Receives: Device: Arctic Front Advance Cardiac CryoAblation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
electrical pulmonary vein isolation
Electrical PV isolation will be determined upon mapping with multielectrode catheter approximately 3 months post-treatment
Measured: approximately 3 months postablation
Secondary outcomes (1)
Clinical AF recurrence
ECG-documented clinical AF recurrence will be measured by ambulatory monitoring approximately 3 months post-treatment
Measured: approximately 3 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic International Trading Sarl
- Responsible party
- Sponsor
- Investigators
- Vivek Y. Reddy, Principal investigator, Nemocnice Na Homolce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645917
- Sponsor's protocol ID
- SUPIR001
- Acronym
- SUPIR
- Status last verified
- Sep 2018
- First submitted
- 18 Jul 2012
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ahmed H, Neuzil P, Skoda J, D'Avila A, Donaldson DM, Laragy MC, Reddy VY. The permanency of pulmonary vein isolation using a balloon cryoablation catheter. J Cardiovasc Electrophysiol. 2010 Jul;21(7):731-7. doi: 10.1111/j.1540-8167.2009.01703.x. Epub 2010 Feb 1.
PubMed 20132391Reddy VY, Sediva L, Petru J, Skoda J, Chovanec M, Chitovova Z, Di Stefano P, Rubin E, Dukkipati S, Neuzil P. Durability of Pulmonary Vein Isolation with Cryoballoon Ablation: Results from the Sustained PV Isolation with Arctic Front Advance (SUPIR) Study. J Cardiovasc Electrophysiol. 2015 May;26(5):493-500. doi: 10.1111/jce.12626. Epub 2015 Apr 15.
PubMed 25644659
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUstained PV Isolation With aRctic Front Advance
- ClinicalTrials.gov ID
- NCT01645917
- Acronym / sponsor ID
- SUPIR / SUPIR001
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- paroxysmal atrial fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic International Trading Sarl
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
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 study is to determine the permanency of PV isolation with the Arctic Front Advance cryoablation system in paroxysmal AF patients. It will also provide data on acute procedural outcomes and measures as well as clinical AF recurrence in these patients approximately 3 months post-ablation.
Detailed description
Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. It is estimated that more than 7 million people worldwide have the disease. Over the past decade, catheter ablation has become an accepted treatment for patients with AF. Ablation strategies that target the pulmonary vein are considered the cornerstone for treatment. The innovative Arctic Front cryoballoon is used for the treatment of drug refractory recurrent symptomatic paroxysmal AF (PAF). The system was designed to overcome many of the challenges of point-by-point catheter ablation by providing an anatomical approach for pulmonary vein isolation (PVI), creating long contiguous circumferential lesions surrounding the pulmonary vein. The cryoballoon system has a low risk of complications and proven efficacy in treating PAF.
AF recurrence rates have been reported up to 30% after initial ablation with PVI technologies including point-by-point RF catheter ablation. Arrhythmia recurrence can be caused by non-contiguous ablation lines that allow conduction gaps. Arctic Front Advance™ Cardiac CryoAblation Catheter (Arctic Front Advance), the second-generation cryoballoon which has recently been introduced following clearance by regulatory agencies in both the US and EU, is positioned to address this challenge with PVI technologies. The new catheter features the EvenCool™ Cryo Technology, which optimizes how the refrigerant is distributed inside the balloon, providing more uniform, distal cooling around the circumference of the balloon. The purpose of this study is to examine the rate of electrical PV isolation with the next generation system .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Device: Arctic Front Advance Cardiac CryoAblation systemAblation with Arctic Front Advance Cardiac CryoAblation system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is at least 18 years old
- Subject has been diagnosed with recurrent, symptomatic paroxysmal atrial fibrillation, documented as per institutional practice
- Left atrial diameter is no larger than 5.5cm
- Subject has failed one or more anti-arrhythmic drugs
- Subject is indicated for a pulmonary vein ablation using Arctic Front Advance
Key exclusion criteria (13 listed)
- Subject has persistent (>7 days) or permanent AF
- Subject has a left atrial thrombus detected on TEE
- Subject has had a prior left atrial ablation
- Subject has an intracardiac thrombus
- Subject is contraindicated for EP study
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 |
|---|---|---|
| Arctic Front Advance Cardiac CryoAblation systemStandard of care ablation for indicated paroxysmal AF patients with Medtronic's Arctic Front Advance Cardiac CryoAblation system | Device | Ablation |
Primary outcome
electrical pulmonary vein isolation
Time frame: approximately 3 months postablation
Electrical PV isolation will be determined upon mapping with multielectrode catheter approximately 3 months post-treatment
1 secondary outcome
Clinical AF recurrence
Time frame: approximately 3 months post-ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Background: PubMed 20132391Ahmed H, Neuzil P, Skoda J, D'Avila A, Donaldson DM, Laragy MC, Reddy VY. The permanency of pulmonary vein isolation using a balloon cryoablation catheter. J Cardiovasc Electrophysiol. 2010 Jul;21(7):731-7. doi: 10.1111/j.1540-8167.2009.01703.x. Epub 2010 Feb 1.
- Derived from this study: PubMed 25644659Reddy VY, Sediva L, Petru J, Skoda J, Chovanec M, Chitovova Z, Di Stefano P, Rubin E, Dukkipati S, Neuzil P. Durability of Pulmonary Vein Isolation with Cryoballoon Ablation: Results from the Sustained PV Isolation with Arctic Front Advance (SUPIR) Study. J Cardiovasc Electrophysiol. 2015 May;26(5):493-500. doi: 10.1111/jce.12626. Epub 2015 Apr 15.
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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.
Vivek Y. Reddy principal investigator
Nemocnice Na Homolce
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arctic Front Advance Cardiac CryoAblation system in people with Paroxysmal Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Czechia.
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 13 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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
electrical pulmonary vein isolation (time frame: approximately 3 months postablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01645917, which also lists 2 linked publications.
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 19 Sep 2018.