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

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

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Radiofrequency Ablation procedure; Device: Radiofrequency Ablation procedure

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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2020
    • A.Z. Middelheim
  • Brugge, Belgium, 8000
    • A.Z. St Jan AV
• Canada
  • Ontario, Canada, L3Y 2P9
    • Southlake Regional Health Centre
  • Ontario
    • Newmarket, Ontario, Canada, L3Y2P9
      • Southlake Regional Health Centre
• Denmark
  • Värde, Denmark, 6800
    • Heart Center Varde
• Germany
  • Köln, Germany, 51149
    • Krankenhaus Porz Cologne
• Netherlands
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Zwolle, Netherlands, 8011
    • Isala Klinieken
• United Kingdom
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • Essex Cardiothoracic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Principal Investigator: Mattias Duytschaever, MD, A.Z. St Jan AV; Principal Investigator: Yves De Greef, MD, A.Z. Middelheim; Principal Investigator: Stuart Harris, MD, Essex Cardiothoracic Centre; Principal Investigator: Peter Steen Hansen, MD, Heart Center Varde; Principal Investigator: Pepijn Van Der Voort, MD, Catharina Ziekenhuis; Principal Investigator: Thomas Deneke, MD, Krankenhaus Porz Cologne; Principal Investigator: Arif Elvan, MD, Isala; Principal Investigator: Yaariv Khaykin, MD, Southlake Regional Health Centre; Principal Investigator: Atul Verma, MD, Southlake Regional Health Centre

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimated): May 5, 2010

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: atrial fibrillation; ablation; radiofrequency; CARTO; PVAC; THERMOCOOL; LASSO
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BWI130