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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)

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Radiofrequency Ablation procedure
Radiofrequency Ablation procedure
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring radiofrequency, ablation, atrial fibrillation, CARTO, THERMOCOOL, LASSO, PVAC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.Z. Middelheim
  • A.Z. St Jan AV
  • Southlake Regional Health Centre
  • Southlake Regional Health Centre
  • Heart Center Varde
  • Krankenhaus Porz Cologne
  • Catharina Ziekenhuis
  • Isala Klinieken
  • Essex Cardiothoracic Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

THERMOCOOL® group

PVAC® group

Arm Description

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

Radiofrequency ablation to achieve PVI using fluoroscopy and the PVAC®

Outcomes

Primary Outcome Measures

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.
Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI)
Total procedure time

Secondary Outcome Measures

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

Full Information

First Posted
May 3, 2010
Last Updated
October 1, 2014
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01116557
Brief Title
Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)
Acronym
CLARITY-AF
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Biosense stopped Study enrollment following publications that reported PVAC ablation is linked with a higher incidence of asymptomatic cerebral embolic lesions
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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®

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
radiofrequency, ablation, atrial fibrillation, CARTO, THERMOCOOL, LASSO, PVAC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THERMOCOOL® group
Arm Type
Other
Arm Description
Radiofrequency ablation to achieve PVI using the CARTO® 3 System, the THERMOCOOL® Catheter and the LASSO® Circular Mapping Catheter.
Arm Title
PVAC® group
Arm Type
Active Comparator
Arm Description
Radiofrequency ablation to achieve PVI using fluoroscopy and the PVAC®
Intervention Type
Device
Intervention Name(s)
Radiofrequency Ablation procedure
Other Intervention Name(s)
CARTO®3 System, LASSO® Circular Mapping Catheter, THERMOCOOL® Catheter
Intervention Description
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
Intervention Name(s)
Radiofrequency Ablation procedure
Other Intervention Name(s)
PVAC®
Intervention Description
Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.
Primary Outcome Measure Information:
Title
Freedom from documented AF/AT recurrences without new AADs
Description
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.
Time Frame
1 year follow-up post-ablation
Title
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
Title
Total procedure time
Time Frame
at the time of the initial ablation procedure
Secondary Outcome Measure Information:
Title
Acute procedural success
Description
Measured by the number (%) of subjects with confirmed entrance block at the end of the ablation procedure
Time Frame
at the time of the initial ablation procedure
Title
Repeat ablation procedures for AF/AT recurrences
Description
Measured by % of subjects undergoing repeat ablation procedures for Recurring AF/AT
Time Frame
through 3-12 month follow-up period post-ablation
Title
Freedom from documented AF/AT recurrences without AAD(s)
Description
Measured by % achieving freedom from documented AF/AT recurrences
Time Frame
through 3-12 month follow-up period post-ablation
Title
Freedom from documented AF/AT recurrences with AAD(s)
Description
Measured by % achieving freedom from documented AF/AT recurrences
Time Frame
through 3-12 month follow-up period post-ablation
Title
Freedom from documented AF/AT recurrences after more than one ablation procedure
Description
Measured by % achieving freedom from documented AF/AT recurrences
Time Frame
through 3-12 month follow-up period post-ablation
Title
Freedom from documented AF recurrences without AADs
Description
Measured by % achieving freedom from documented AF/AT recurrences
Time Frame
through 3-12 month follow-up period post-ablation
Title
Freedom from documented AF recurrences with AAD(s)
Description
Measured by % achieving freedom from documented AF/AT recurrences
Time Frame
through 3-12 month follow-up period post-ablation
Title
Freedom from documented symptomatic AF/AT recurrences without new AAD(s)
Description
Measured by % achieving freedom from documented symptomatic AF/AT recurrences
Time Frame
through 3-12 month follow-up period post-ablation
Title
Freedom from documented symptomatic AF/AT recurrences with AAD(s)
Time Frame
through 3-12 month follow-up period post-ablation
Title
Incidence of any procedure-related and/or device-related adverse events occurring during the study
Time Frame
through 1 year follow-up
Title
Incidence of any catheter-related adverse events
Time Frame
during 7 days follow-up post-ablation
Title
Total Fluoroscopy exposure time
Description
Measured by fluoroscopy and cine-fluoroscopy time throughout procedure
Time Frame
at the time of the ablation procedure
Title
Total Fluoroscopy Dose-Area Product/Source Intensifier Distance
Time Frame
at the time of the ablation procedure
Title
Incidence of any phrenic nerve paralysis
Time Frame
through 1 year follow-up post-ablation
Title
Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA)
Time Frame
through 1 year follow-up post-ablation
Title
Number of mapping and ablation catheters used per subject
Time Frame
through 1 year follow-up post-ablation
Title
Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment
Time Frame
Baseline, 3, 6 and 12 months
Title
Total procedure hospital visit and ablation procedure costs
Time Frame
during hospitalization stay for study treatment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias Duytschaever, MD
Organizational Affiliation
A.Z. St Jan AV
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yves De Greef, MD
Organizational Affiliation
A.Z. Middelheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stuart Harris, MD
Organizational Affiliation
Essex Cardiothoracic Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Steen Hansen, MD
Organizational Affiliation
Heart Center Varde
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pepijn Van Der Voort, MD
Organizational Affiliation
Catharina Ziekenhuis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Deneke, MD
Organizational Affiliation
Krankenhaus Porz Cologne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Atul Verma, MD
Organizational Affiliation
Southlake Regional Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arif Elvan, MD
Organizational Affiliation
Isala
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yaariv Khaykin, MD
Organizational Affiliation
Southlake Regional Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.Z. Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
A.Z. St Jan AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y2P9
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Heart Center Varde
City
Värde
ZIP/Postal Code
6800
Country
Denmark
Facility Name
Krankenhaus Porz Cologne
City
Köln
ZIP/Postal Code
51149
Country
Germany
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8011
Country
Netherlands
Facility Name
Essex Cardiothoracic Centre
City
Basildon
State/Province
Essex
ZIP/Postal Code
SS16 5NL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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