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

NCT ID: NCT01116557

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-12-31

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®

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

THERMOCOOL® group

Radiofrequency ablation to achieve PVI using the CARTO® 3 System, the THERMOCOOL® Catheter and the LASSO® Circular Mapping Catheter.

Group Type: OTHER

Radiofrequency Ablation procedure

Intervention Type: DEVICE

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.

PVAC® group

Radiofrequency ablation to achieve PVI using fluoroscopy and the PVAC®

Group Type: ACTIVE_COMPARATOR

Radiofrequency Ablation procedure

Intervention Type: DEVICE

Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.

Interventions

Radiofrequency Ablation procedure

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.

Intervention Type: DEVICE

Radiofrequency Ablation procedure

Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.

Intervention Type: DEVICE

Other Intervention Names

CARTO®3 System; LASSO® Circular Mapping Catheter; THERMOCOOL® Catheter; PVAC®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mattias Duytschaever, MD

Role: PRINCIPAL_INVESTIGATOR

A.Z. St Jan AV

Yves De Greef, MD

Role: PRINCIPAL_INVESTIGATOR

A.Z. Middelheim

Stuart Harris, MD

Role: PRINCIPAL_INVESTIGATOR

Essex Cardiothoracic Centre

Peter Steen Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Varde

Pepijn Van Der Voort, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis

Thomas Deneke, MD

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus Porz Cologne

Atul Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Southlake Regional Health Centre

Arif Elvan, MD

Role: PRINCIPAL_INVESTIGATOR

Isala

Yaariv Khaykin, MD

Role: PRINCIPAL_INVESTIGATOR

Southlake Regional Health Centre

Other Identifiers

BWI130

Identifier Type: -

Identifier Source: org_study_id