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Irrigated Ablation System Evaluation for AF (IRASE-AF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01056328
First received: January 22, 2010
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Paroxysmal Atrial Fibrillation
 Device: SJM Irrigated Cardiac Ablation System
Device: FDA approved Open Irrigated RF Ablation System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Irrigated Ablation System Evaluation for AF

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from symptomatic AF during nine months following the blanking period [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Confirmation of entrance block in the pulmonary veins [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Incidence of adverse events included in the pre-specified composite [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events included in the pre-specified composite. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Documented (> 30 seconds) asymptomatic episodes of AF, AFL or AT after the blanking period [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Early onset (within 90 days) of SAE/Non-serious AEs and late onset (after 90 days) SAEs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 324
Study Start Date: February 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SJM Cardiac Ablation System Device: SJM Irrigated Cardiac Ablation System
Irrigated ablation catheter
Active Comparator: FDA approved Open Irriagated RF Ablation System Device: FDA approved Open Irrigated RF Ablation System
Irrigated ablation catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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*

    • Paroxysmal AF is defined as recurrent AF that terminates spontaneously within seven days.

Exclusion Criteria:

  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Previous ablation for AF
  • History of any valvular cardiac surgical procedure
  • CABG procedure within the last six months
  • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
  • Left atrial thrombus
  • History of a documented thromboembolic event within the past one (1) year
  • Diagnosed atrial myxoma
  • An implanted 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 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056328

  Show 30 Study Locations
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01056328     History of Changes
Other Study ID Numbers: 90030928
Study First Received: January 22, 2010
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013