Clinical trial NCT00116428: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
Official title: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Diseases
Arrhythmia
Atrial Fibrillation
Keywords: Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2005-06-30
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.


Eligibility criteria: You may be eligible to participate in this study if you: Have failed to respond to drug treatment for your AFib, or find the side effects of your medication intolerable.

Inclusion Criteria

* Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to randomization, one of which must be documented. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
* Failure of at least one AAD for PAF \[class I or III or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)\] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD.
* Signed Patient Informed Consent Form.
* Age 18 years or older.
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Exclusion Criteria

* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
* Previous ablation for atrial fibrillation.
* Patients on amiodarone therapy at any time during the previous six (6) months.
* AF episodes that last longer than 30 days and are terminated via cardioversion.
* Any valvular cardiac surgical procedure.
* CABG procedure within the last 180 days (six months).
* Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months).
* Documented left atrial thrombus on imaging (e.g. TEE).
* History of a documented thromboembolic event within the past one (1) year.
* Diagnosed atrial myxoma.
* Presence of 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 60 days (two months).
* LVEF \< 40%.
* History of blood clotting or bleeding abnormalities.
* Contraindication to anticoagulation (i.e. heparin or warfarin).
* Contraindication to CT/MRA procedure.
* Life expectancy less than 360 days (12 months).
* Enrollment in an investigational study evaluating another device or drug.
* Uncontrolled heart failure or NYHA class III or IV heart failure.
* Presence of 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

Primary outcomes:
measure: The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)
timeFrame: The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure.
measure: The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events
timeFrame: Within 7 Days of Ablation Procedure
Secondary outcomes:
measure: The Percentage of Subjects Who Achieved Acute Success.
timeFrame: 90 days post study procedure
measure: Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.
timeFrame: During the two years of post procedure
measure: Percentage of Subjects Responded to Each of the Four Health Status Categories.
timeFrame: During the two years of post procedure
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Marin General Hospital
state: California
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: New York
country: United States
facility: St. Lukes Roosevelt Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano Baylor Research Institute
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Sao Paulo
country: Brazil
facility: Hospital Sao Paulo
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Praha 5
country: Czechia
facility: Na Homolce Hospital
state: Motol
city: Milan
country: Italy
facility: Hospital San Raffaele
Study officials:
affiliation: Loyola University
name: David Wilber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):333-40. doi: 10.1001/jama.2009.2029.
citation: Reynolds MR, Walczak J, White SA, Cohen DJ, Wilber DJ. Improvements in symptoms and quality of life in patients with paroxysmal atrial fibrillation treated with radiofrequency catheter ablation versus antiarrhythmic drugs. Circ Cardiovasc Qual Outcomes. 2010 Nov;3(6):615-23. doi: 10.1161/CIRCOUTCOMES.110.957563. Epub 2010 Oct 12.