Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.

Detailed Description
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This study is a prospective, multi-center, randomized (2:1), controlled, two-arm, unblinded, clinical study, which will evaluate the efficacy, safety, and efficiency of CARTO® 3 System-guided RF ablation (using the THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter) compared to fluoroscopy-guided RF ablation (using the PVAC®). Patients with symptomatic PAF who meet the inclusion criteria will be considered for study participation and may be enrolled if no exclusion criteria apply. Eligible subjects who signed the study informed consent form will be randomized into one of two treatment groups: THERMOCOOL® Group: RF ablation to achieve PVI using the CARTO® 3 System, THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter PVAC® Group: RF ablation to achieve PVI using fluoroscopy and the PVAC®

Official Title
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CARTO® 3 System-guided RF Ablation Using the THERMOCOOL® Catheter Versus Fluoroscopy-guided RF Ablation Using the Pulmonary Vein Ablation Catheter® (PVAC®) in Subjects With Paroxysmal Atrial Fibrillation: A Prospective, Multi-center, Randomized (2:1), Controlled, Two-arm, Unblinded Clinical Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Radiofrequency Ablation procedure
* Device: Radiofrequency Ablation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF (supported by the consensus statement2). At least one AF episode should be documented either on ECG, TTM, HM or telemetry strip. Failure of at least one AAD for PAF [class I or III] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to the AAD. Signed Patient Informed Consent Form. Age 18 years or older. Able and willing to comply with all pre- and follow-up testing and requirements. Exclusion Criteria: Longstanding persistent atrial fibrillation Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion Previous ablation for AF LA size > 55 mm LVEF < 40% (ejection fraction) AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause CABG procedure within the last six (6) months Awaiting cardiac transplantation or other cardiac surgery Documented left atrial thrombus on imaging (eg, TEE) Diagnosed atrial myxoma Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable) or breastfeeding Acute illness or active systemic infection or sepsis Unstable angina Uncontrolled heart failure Myocardial infarction within the previous two (2) months History of blood clotting or bleeding abnormalities Contraindication to anticoagulation therapy (ie. heparin or warfarin) Life expectancy less than 12 months Enrollment in any other study evaluating another device or drug Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: THERMOCOOL® group<br>Radiofrequency ablation to achieve PVI using the CARTO® 3 System, the THERMOCOOL® Catheter and the LASSO® Circular Mapping Catheter. | Device: Radiofrequency Ablation procedure<br>* Radiofrequency Ablation procedure Application of radiofrequency energy with the THERMOCOOL® catheter used in combination with the CARTO® 3 System and the LASSO® Circular Mapping Catheter to eliminate potentials arising from the pulmonary veins.<br>* Other names: THERMOCOOL® Catheter;|
| Active Comparator: PVAC® group<br>Radiofrequency ablation to achieve PVI using fluoroscopy and the PVAC® | Device: Radiofrequency Ablation procedure<br>* Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.<br>* Other names: PVAC®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from documented AF/AT recurrences without new AADs | Subjects will be considered a success for the primary efficacy endpoint if the subject is free from documented recurrences of AF or AT lasting more than 30s as measured with Transtelephonic Monitoring and Standard of Care arrhythmia monitoring during a 3-12 month follow-up period post-ablation. | 1 year follow-up post-ablation | 
| Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI) |  | at 6 months post-ablation | 
| Total procedure time |  | at the time of the initial ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute procedural success | Measured by the number (%) of subjects with confirmed entrance block at the end of the ablation procedure | at the time of the initial ablation procedure | 
| Repeat ablation procedures for AF/AT recurrences | Measured by % of subjects undergoing repeat ablation procedures for Recurring AF/AT | through 3-12 month follow-up period post-ablation | 
| Freedom from documented AF/AT recurrences without AAD(s) | Measured by % achieving freedom from documented AF/AT recurrences | through 3-12 month follow-up period post-ablation | 
| Freedom from documented AF/AT recurrences with AAD(s) | Measured by % achieving freedom from documented AF/AT recurrences | through 3-12 month follow-up period post-ablation | 
| Freedom from documented AF/AT recurrences after more than one ablation procedure | Measured by % achieving freedom from documented AF/AT recurrences | through 3-12 month follow-up period post-ablation | 
| Freedom from documented AF recurrences without AADs | Measured by % achieving freedom from documented AF/AT recurrences | through 3-12 month follow-up period post-ablation | 
| Freedom from documented AF recurrences with AAD(s) | Measured by % achieving freedom from documented AF/AT recurrences | through 3-12 month follow-up period post-ablation | 
| Freedom from documented symptomatic AF/AT recurrences without new AAD(s) | Measured by % achieving freedom from documented symptomatic AF/AT recurrences | through 3-12 month follow-up period post-ablation | 
| Freedom from documented symptomatic AF/AT recurrences with AAD(s) |  | through 3-12 month follow-up period post-ablation | 
| Incidence of any procedure-related and/or device-related adverse events occurring during the study |  | through 1 year follow-up | 
| Incidence of any catheter-related adverse events |  | during 7 days follow-up post-ablation | 
| Total Fluoroscopy exposure time | Measured by fluoroscopy and cine-fluoroscopy time throughout procedure | at the time of the ablation procedure | 
| Total Fluoroscopy Dose-Area Product/Source Intensifier Distance |  | at the time of the ablation procedure | 
| Incidence of any phrenic nerve paralysis |  | through 1 year follow-up post-ablation | 
| Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA) |  | through 1 year follow-up post-ablation | 
| Number of mapping and ablation catheters used per subject |  | through 1 year follow-up post-ablation | 
| Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment |  | Baseline, 3, 6 and 12 months | 
| Total procedure hospital visit and ablation procedure costs |  | during hospitalization stay for study treatment | 
| Total number of initial or prolonged hospitalizations and unscheduled arrhythmia-related health care provider visits (including emergency department visits) |  | through 1 year follow-up post-ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiofrequency, ablation, atrial fibrillation, CARTO, THERMOCOOL, LASSO, PVAC