Atrial Fibrillation MedDRA version: 16.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Biosense Webster, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with recurrent AF for 2 years, with = 2 episodes over the last 6 months; 1 episode within the last 1 year (12 months) must be documented by electrocardiogram (ECG), TTM, HM, or telemetry strip. • HATCH Score of at least =1 and = 4. • Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug). • Age 60 years or older. • LA diameter = 55mm by TTE. • LV ejection fraction = 50% when in sinus rhythm or LV ejection fraction = 35% when in AF. • Signed Patient Informed Consent Form. • Able and willing to comply with protocol requirements, including all baseline and followup testing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 280
Exclusion criteria
Exclusion criteria: • Patients awaiting cardiac transplantation or other cardiac surgery. • Acute illness (ongoing) or active systemic infection or sepsis. • Reversible causes of AF, including thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma. • Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months. • Heart failure decompensation. • Previous stroke. • Pulmonary embolism or recent atrial embolism/thrombosis. • Hypertrophic obstructive cardiomyopathy. • Class IV angina or Class IV CHF (including past or planned heart transplantation). • Mandated anti-arrhythmic drug therapy for disease conditions other than AF. • Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs. • Prior LA catheter ablation with the intention of treating AF; prior surgical interventions for AF such as the MAZE procedure. • Prior AV nodal ablation. • Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use. • Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications. • Medical conditions limiting expected survival to < 3 years. • Concurrent participation in any other clinical study. • Prior history of non-adherence to prescribed drug regimens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to determine whether early RF ablation treatment, using the CARTO® 3 or CARTO ® XP System, and THERMOCOOL ® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with Paroxysmal AF (PAF), delays progression of AF compared with drug therapy (either rate or rhythm control) using current AF management guidelines.;Secondary Objective: Not applicable;Primary end point(s): Time to persistent AF/AT (excluding isthmus-dependent atrial flutter) at 3 years. Persistent AF/AT is defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effectiveness: • Rate and time to persistent AF/AT at 1 year and 2 years, rate of persistent AF/AT by number of ablations at 3 years. • Number of repeat ablations and new AAD drugs per subject throughout 3 years followup. • Rhythm (% subjects in SR, % subjects with recurrent AF) throughout 3 years follow-up. • Subject’s pre-existing or new onset/worsened condition(s), that may be associated with AF progression, will be collected at baseline and at each follow up visit throughout the 3-year study period; parameters include subject’s age and gender and the following assessments of non-AF health status: LA size; HATCH Score; blood pressure; NYHA Functional of heart disease; diabetes; lipid profile; renal function and, dementia. Safety: • Catheter-related complications (ablation); adverse drug reactions (AAD). Health Economics (HE) Outcomes: • Health care utilization (number and length of hospitalizations and unscheduled cardiovascular-related visits). • Quality of Life (QoL) at 3 months, 6 months, 1 year,2 years and 3 years by EQ-5D and AFEQT Questionnaire and change from baseline.;Timepoint(s) of evaluation of this end point: secondary end points are evaluated at 3 months, 6 months, 1 year, 2 years and 3 years as described above | — |
Countries
Austria, China, Czech Republic, Germany, Ireland, Russian Federation, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactClinical Study Information
Biosense Webster, Inc
Outcome results
None listed