Irrigated Ablation System Evaluation for AF - Full Text View

Sponsor:	St. Jude Medical
Information provided by (Responsible Party):	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT01056328

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

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 23, 2012