Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation (SUPIR)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Czechia
Study Type
Interventional
Intervention
Arctic Front Advance Cardiac CryoAblation system
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring paroxysmal atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Homolka Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ablation
Arm Description
Ablation with Arctic Front Advance Cardiac CryoAblation system
Outcomes
Primary Outcome Measures
electrical pulmonary vein isolation
Electrical PV isolation will be determined upon mapping with multielectrode catheter approximately 3 months post-treatment
Secondary Outcome Measures
Clinical AF recurrence
ECG-documented clinical AF recurrence will be measured by ambulatory monitoring approximately 3 months post-treatment
Full Information
NCT ID
NCT01645917
First Posted
July 18, 2012
Last Updated
September 17, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic International Trading Sarl
1. Study Identification
Unique Protocol Identification Number
NCT01645917
Brief Title
Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation
Acronym
SUPIR
Official Title
SUstained PV Isolation With aRctic Front Advance
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic International Trading Sarl
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
paroxysmal atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ablation
Arm Type
Experimental
Arm Description
Ablation with Arctic Front Advance Cardiac CryoAblation system
Intervention Type
Device
Intervention Name(s)
Arctic Front Advance Cardiac CryoAblation system
Intervention Description
Standard of care ablation for indicated paroxysmal AF patients with Medtronic's Arctic Front Advance Cardiac CryoAblation system
Primary Outcome Measure Information:
Title
electrical pulmonary vein isolation
Description
Electrical PV isolation will be determined upon mapping with multielectrode catheter approximately 3 months post-treatment
Time Frame
approximately 3 months postablation
Secondary Outcome Measure Information:
Title
Clinical AF recurrence
Description
ECG-documented clinical AF recurrence will be measured by ambulatory monitoring approximately 3 months post-treatment
Time Frame
approximately 3 months post-ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Y. Reddy
Organizational Affiliation
Nemocnice Na Homolce
Official's Role
Principal Investigator
Facility Information:
Facility Name
Homolka Hospital
City
Prague
Country
Czechia
12. IPD Sharing Statement
Citations:
PubMed Identifier
20132391
Citation
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.
Results Reference
background
PubMed Identifier
25644659
Citation
Reddy 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.
Results Reference
derived
Learn more about this trial
Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation
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