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

Phase 4

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Device: Radiofrequency Ablation procedure

• Registration Number: NCT01116557
• Lead Sponsor: Biosense Webster, Inc.

Brief Summary

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

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®

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
PVAC® group	Radiofrequency Ablation procedure	Radiofrequency ablation to achieve PVI using fluoroscopy and the PVAC®
THERMOCOOL® group	Radiofrequency Ablation procedure	Radiofrequency ablation to achieve PVI using the CARTO® 3 System, the THERMOCOOL® Catheter and the LASSO® Circular Mapping Catheter.

Primary Outcome Measures

Name	Time	Method
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
Freedom from documented AF/AT recurrences without new AADs	1 year follow-up post-ablation	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.
Total procedure time	at the time of the initial ablation procedure

Secondary Outcome Measures

Name	Time	Method
Number of mapping and ablation catheters used per subject	through 1 year follow-up post-ablation
Freedom from documented AF/AT recurrences with AAD(s)	through 3-12 month follow-up period post-ablation	Measured by % achieving freedom from documented AF/AT recurrences
Incidence of any catheter-related adverse events	during 7 days follow-up post-ablation
Total Fluoroscopy Dose-Area Product/Source Intensifier Distance	at the time of the ablation procedure
Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA)	through 1 year follow-up post-ablation
Acute procedural success	at the time of the initial ablation procedure	Measured by the number (%) of subjects with confirmed entrance block at the end of the ablation procedure
Freedom from documented AF/AT recurrences without AAD(s)	through 3-12 month follow-up period post-ablation	Measured by % achieving freedom from documented AF/AT recurrences
Freedom from documented AF recurrences with AAD(s)	through 3-12 month follow-up period post-ablation	Measured by % achieving freedom from documented AF/AT recurrences
Freedom from documented symptomatic AF/AT recurrences without new AAD(s)	through 3-12 month follow-up period post-ablation	Measured by % achieving freedom from documented symptomatic AF/AT recurrences
Total Fluoroscopy exposure time	at the time of the ablation procedure	Measured by fluoroscopy and cine-fluoroscopy time throughout procedure
Incidence of any phrenic nerve paralysis	through 1 year follow-up post-ablation
Freedom from documented AF/AT recurrences after more than one ablation procedure	through 3-12 month follow-up period post-ablation	Measured by % achieving freedom from documented AF/AT recurrences
Repeat ablation procedures for AF/AT recurrences	through 3-12 month follow-up period post-ablation	Measured by % of subjects undergoing repeat ablation procedures for Recurring AF/AT
Freedom from documented AF recurrences without AADs	through 3-12 month follow-up period post-ablation	Measured by % achieving freedom from documented AF/AT recurrences
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
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

Trial Locations

Locations (8)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Southlake Regional Health Centre; 🇨🇦 Ontario, Canada

Krankenhaus Porz Cologne; 🇩🇪 Köln, Germany

A.Z. St Jan AV; 🇧🇪 Brugge, Belgium

Isala Klinieken; 🇳🇱 Zwolle, Netherlands

Essex Cardiothoracic Centre; 🇬🇧 Basildon, Essex, United Kingdom

Heart Center Varde; 🇩🇰 Värde, Denmark

A.Z. Middelheim; 🇧🇪 Antwerpen, Belgium