Paroxysmal Atrial FibrillationIRASE-AFNCT01056328
Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
A study testing SJM Irrigated Cardiac Ablation System and FDA approved Open Irrigated RF Ablation System in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 30 sites in 3 countries.
Trial summary
The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation. 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?
- SJM Irrigated Cardiac Ablation System and FDA approved Open Irrigated RF Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 30 sitesin 3 countries
- Study dates
- Feb 2010to Jan 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Signed Patient Informed Consent Form
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
- Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation* [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation*, or intolerable side effects due to AAD
- Subjects with symptomatic paroxysmal atrial fibrillation (PAF)*
- PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.
Who cannot join
- Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous ablation for AF
- History of any valvular cardiac surgical procedure
- Coronary artery bypass grafting (CABG) procedure within the last six months
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
- Left atrial thrombus
Show all 25Show fewer
- History of a documented thromboembolic event within the past one (1) year
- Diagnosed atrial myxoma
- An implanted implantable cardioverter defibrillator (ICD)
- Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable)
- Acute illness or active systemic infection or sepsis
- Unstable angina
- Myocardial infarction within the previous two months
- Left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure transthoracic echocardiogram (TTE)
- History of blood clotting or bleeding abnormalities
- Contraindication to anticoagulation (i.e. heparin or warfarin)
- Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure
- Life expectancy less than 12 months
- Enrollment in an investigational study evaluating another device or drug
- Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure
- An intramural thrombus tumor, or other abnormality that precludes catheter introduction or manipulation
- Presence of a condition that precludes vascular access
- Left atrial size ≥ 50 mm as determined by pre-procedure TTE
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States27 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78746
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Virginia Health System
Charlottesville, Virginia, 22908
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Colorado Cardiac Alliance
Colorado Springs, Colorado, 80907
The Ohio State University Medical Center
Columbus, Ohio, 43210
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Emory University Hospital, Midtown
Emory, Georgia, 30308
Inova Fairfax Hospital / Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
Spectrum Health
Grand Rapids, Michigan, 49503
The Methodist Hospital Research Institute
Houston, Texas, 77030
Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center
Jacksonville, Florida, 32204
University of Kansas Hospital
Kansas City, Kansas, 66160
MAHI, Saint Luke's Hospital
Kansas City, Missouri, 64111
Good Samaritan Hospital
Los Angeles, California, 90017
Centennial Medical Center
Nashville, Tennessee, 37203
NYU Langone Medical Center
New York, New York, 10016
Mount Sinai Hospital
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Rochester
Rochester, New York, 14642
Intermountain Medical Center
Salt Lake City, Utah, 84157
University of Californai, San Diego Medical Center
San Diego, California, 92037
Arizona Arrhythmia Consultants/Scottsdale Healthcare
Scottsdale, Arizona, 85251
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Tampa General Hospital
Tampa, Florida, 33606
South Korea2 sites
Severance Hospital
Seoul, 120-752
Korea University Anam Hospital
Seoul, 136-705
About this study
Official title: Irrigated Ablation System Evaluation for AF
The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- SJM Irrigated Cardiac Ablation System, FDA approved Open Irrigated RF Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJM Irrigated Cardiac Ablation SystemDevice
Irrigated ablation catheter
FDA approved Open Irrigated RF Ablation SystemDevice
Irrigated ablation catheter
| Study group | Role | What they receive |
|---|---|---|
| St. Jude Medical Cardiac Ablation System | Experimental | Not described Receives: Device: SJM Irrigated Cardiac Ablation System |
| FDA approved Open Irrigated Radio Frequency Ablation System | Active comparator | Not described Receives: Device: FDA approved Open Irrigated RF Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of Entrance Block in the Pulmonary Veins
Measured: 20 minutes after initial isolation
Incidence of Adverse Events Included in the Pre-specified Composite
Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.
Measured: 7 days
Incidence of Adverse Events Included in the Pre-specified Composite.
Measured: 12 months
Secondary outcomes (2)
Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
Measured: 12 months
Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs
Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2013
- Study completionJan 2013
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 Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056328
- Sponsor's protocol ID
- 90030928
- Acronym
- IRASE-AF
- Status last verified
- Feb 2019
- First submitted
- 22 Jan 2010
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irrigated Ablation System Evaluation for AF
- ClinicalTrials.gov ID
- NCT01056328
- Acronym / sponsor ID
- IRASE-AF / 90030928
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 23 May 2014
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 this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| St. Jude Medical Cardiac Ablation System | Experimental | Device: SJM Irrigated Cardiac Ablation System |
| FDA approved Open Irrigated Radio Frequency Ablation System | Active comparator | Device: FDA approved Open Irrigated RF Ablation 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)
- Age 18 years or older
- Signed Patient Informed Consent Form
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
- Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation* [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation*, or intolerable side effects due to AAD
- Subjects with symptomatic paroxysmal atrial fibrillation (PAF)*
Key exclusion criteria (25 listed)
- Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous ablation for AF
- History of any valvular cardiac surgical procedure
- Coronary artery bypass grafting (CABG) procedure within the last six months
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
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 |
|---|---|---|
| SJM Irrigated Cardiac Ablation SystemIrrigated ablation catheter | Device | St. Jude Medical Cardiac Ablation System |
| FDA approved Open Irrigated RF Ablation SystemIrrigated ablation catheter | Device | FDA approved Open Irrigated Radio Frequency Ablation System |
Primary outcome
Confirmation of Entrance Block in the Pulmonary Veins
Time frame: 20 minutes after initial isolation
Incidence of Adverse Events Included in the Pre-specified Composite
Time frame: 7 days
Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.
Incidence of Adverse Events Included in the Pre-specified Composite.
Time frame: 12 months
2 secondary outcomes
Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
Time frame: 12 months
Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SJM Irrigated Cardiac Ablation System and FDA approved Open Irrigated RF Ablation System in people with Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 30 sites in 3 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 25 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, South Korea, 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 23 May 2014). 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?
Confirmation of Entrance Block in the Pulmonary Veins (time frame: 20 minutes after initial isolation). The study lists 3 primary outcomes in all. 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 26 Feb 2019.