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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01116557
• Other study ID #: BWI130
• Status: Terminated
• Phase: Phase 4
• First received: May 3, 2010
• Last updated: October 1, 2014
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2014
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Commissie voor Medische Ethiek A.Z. St Jan AV
• Study type: Interventional

Clinical Trial 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.

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®

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Belgium	A.Z. Middelheim	Antwerpen
Belgium	A.Z. St Jan AV	Brugge
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Southlake Regional Health Centre	Ontario
Denmark	Heart Center Varde	Värde
Germany	Krankenhaus Porz Cologne	Köln
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Isala Klinieken	Zwolle
United Kingdom	Essex Cardiothoracic Centre	Basildon	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Primary	Total procedure time		at the time of the initial ablation procedure	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Freedom from documented symptomatic AF/AT recurrences with AAD(s)		through 3-12 month follow-up period post-ablation	No
Secondary	Incidence of any procedure-related and/or device-related adverse events occurring during the study		through 1 year follow-up	Yes
Secondary	Incidence of any catheter-related adverse events		during 7 days follow-up post-ablation	Yes
Secondary	Total Fluoroscopy exposure time	Measured by fluoroscopy and cine-fluoroscopy time throughout procedure	at the time of the ablation procedure	Yes
Secondary	Total Fluoroscopy Dose-Area Product/Source Intensifier Distance		at the time of the ablation procedure	Yes
Secondary	Incidence of any phrenic nerve paralysis		through 1 year follow-up post-ablation	Yes
Secondary	Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA)		through 1 year follow-up post-ablation	Yes
Secondary	Number of mapping and ablation catheters used per subject		through 1 year follow-up post-ablation	No
Secondary	Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment		Baseline, 3, 6 and 12 months	No
Secondary	Total procedure hospital visit and ablation procedure costs		during hospitalization stay for study treatment	No
Secondary	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	No