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)

This study has been terminated.
(Biosense stopped Study enrollment following publications that reported PVAC ablation is linked with a higher incidence of asymptomatic cerebral embolic lesions)
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01116557
First received: May 3, 2010
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Device: Radiofrequency Ablation procedure
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Freedom from documented AF/AT recurrences without new AADs [ Time Frame: 1 year follow-up post-ablation ] [ Designated as safety issue: No ]
    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.

  • Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI) [ Time Frame: at 6 months post-ablation ] [ Designated as safety issue: Yes ]
  • Total procedure time [ Time Frame: at the time of the initial ablation procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute procedural success [ Time Frame: at the time of the initial ablation procedure ] [ Designated as safety issue: No ]
    Measured by the number (%) of subjects with confirmed entrance block at the end of the ablation procedure

  • Repeat ablation procedures for AF/AT recurrences [ Time Frame: through 3-12 month follow-up period post-ablation ] [ Designated as safety issue: No ]
    Measured by % of subjects undergoing repeat ablation procedures for Recurring AF/AT

  • Freedom from documented AF/AT recurrences without AAD(s) [ Time Frame: through 3-12 month follow-up period post-ablation ] [ Designated as safety issue: No ]
    Measured by % achieving freedom from documented AF/AT recurrences

  • Freedom from documented AF/AT recurrences with AAD(s) [ Time Frame: through 3-12 month follow-up period post-ablation ] [ Designated as safety issue: No ]
    Measured by % achieving freedom from documented AF/AT recurrences

  • Freedom from documented AF/AT recurrences after more than one ablation procedure [ Time Frame: through 3-12 month follow-up period post-ablation ] [ Designated as safety issue: No ]
    Measured by % achieving freedom from documented AF/AT recurrences

  • Freedom from documented AF recurrences without AADs [ Time Frame: through 3-12 month follow-up period post-ablation ] [ Designated as safety issue: No ]
    Measured by % achieving freedom from documented AF/AT recurrences

  • Freedom from documented AF recurrences with AAD(s) [ Time Frame: through 3-12 month follow-up period post-ablation ] [ Designated as safety issue: No ]
    Measured by % achieving freedom from documented AF/AT recurrences

  • Freedom from documented symptomatic AF/AT recurrences without new AAD(s) [ Time Frame: through 3-12 month follow-up period post-ablation ] [ Designated as safety issue: No ]
    Measured by % achieving freedom from documented symptomatic AF/AT recurrences

  • Freedom from documented symptomatic AF/AT recurrences with AAD(s) [ Time Frame: through 3-12 month follow-up period post-ablation ] [ Designated as safety issue: No ]
  • Incidence of any procedure-related and/or device-related adverse events occurring during the study [ Time Frame: through 1 year follow-up ] [ Designated as safety issue: Yes ]
  • Incidence of any catheter-related adverse events [ Time Frame: during 7 days follow-up post-ablation ] [ Designated as safety issue: Yes ]
  • Total Fluoroscopy exposure time [ Time Frame: at the time of the ablation procedure ] [ Designated as safety issue: Yes ]
    Measured by fluoroscopy and cine-fluoroscopy time throughout procedure

  • Total Fluoroscopy Dose-Area Product/Source Intensifier Distance [ Time Frame: at the time of the ablation procedure ] [ Designated as safety issue: Yes ]
  • Incidence of any phrenic nerve paralysis [ Time Frame: through 1 year follow-up post-ablation ] [ Designated as safety issue: Yes ]
  • Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA) [ Time Frame: through 1 year follow-up post-ablation ] [ Designated as safety issue: Yes ]
  • Number of mapping and ablation catheters used per subject [ Time Frame: through 1 year follow-up post-ablation ] [ Designated as safety issue: No ]
  • Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Total procedure hospital visit and ablation procedure costs [ Time Frame: during hospitalization stay for study treatment ] [ Designated as safety issue: No ]
  • Total number of initial or prolonged hospitalizations and unscheduled arrhythmia-related health care provider visits (including emergency department visits) [ Time Frame: through 1 year follow-up post-ablation ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: PVAC® group
Radiofrequency ablation to achieve PVI using fluoroscopy and the PVAC®
Device: Radiofrequency Ablation procedure
Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.
Other Name: PVAC®

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®
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116557

Locations
Belgium
A.Z. Middelheim
Antwerpen, Belgium, 2020
A.Z. St Jan AV
Brugge, Belgium, 8000
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y2P9
Canada
Southlake Regional Health Centre
Ontario, Canada, L3Y 2P9
Denmark
Heart Center Varde
Värde, Denmark, 6800
Germany
Krankenhaus Porz Cologne
Köln, Germany, 51149
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Isala Klinieken
Zwolle, Netherlands, 8011
United Kingdom
Essex Cardiothoracic Centre
Basildon, Essex, United Kingdom, SS16 5NL
Sponsors and Collaborators
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: Atul Verma, MD Southlake Regional Health Centre
Principal Investigator: Arif Elvan, MD Isala Klinieken
Principal Investigator: Yaariv Khaykin, MD Southlake Regional Health Centre
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01116557     History of Changes
Other Study ID Numbers: BWI130
Study First Received: May 3, 2010
Last Updated: October 1, 2014
Health Authority: Belgium: Commissie voor Medische Ethiek A.Z. St Jan AV

Keywords provided by Biosense Webster, Inc.:
radiofrequency
ablation
atrial fibrillation
CARTO
THERMOCOOL
LASSO
PVAC

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014