Clinical trial NCT01116557: Efficacy, Safety and Efficiency Study of CARTO® 3 System Guided THERMOCOOL® Catheter Ablation Versus Fluoroscopy Guided Ablation With the Pulmonary Vein Ablation Catheter® (PVAC®)
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: radiofrequency
ablation
atrial fibrillation
CARTO
THERMOCOOL
LASSO
PVAC
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-05
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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®

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

Primary outcomes:
measure: Freedom from documented AF/AT recurrences without new AADs
timeFrame: 1 year follow-up post-ablation
measure: Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI)
timeFrame: at 6 months post-ablation
measure: Total procedure time
timeFrame: at the time of the initial ablation procedure
Secondary outcomes:
measure: Acute procedural success
timeFrame: at the time of the initial ablation procedure
measure: Repeat ablation procedures for AF/AT recurrences
timeFrame: through 3-12 month follow-up period post-ablation
measure: Freedom from documented AF/AT recurrences without AAD(s)
timeFrame: through 3-12 month follow-up period post-ablation
measure: Freedom from documented AF/AT recurrences with AAD(s)
timeFrame: through 3-12 month follow-up period post-ablation
measure: Freedom from documented AF/AT recurrences after more than one ablation procedure
timeFrame: through 3-12 month follow-up period post-ablation
measure: Freedom from documented AF recurrences without AADs
timeFrame: through 3-12 month follow-up period post-ablation
measure: Freedom from documented AF recurrences with AAD(s)
timeFrame: through 3-12 month follow-up period post-ablation
measure: Freedom from documented symptomatic AF/AT recurrences without new AAD(s)
timeFrame: through 3-12 month follow-up period post-ablation
measure: Freedom from documented symptomatic AF/AT recurrences with AAD(s)
timeFrame: through 3-12 month follow-up period post-ablation
measure: Incidence of any procedure-related and/or device-related adverse events occurring during the study
timeFrame: through 1 year follow-up
measure: Incidence of any catheter-related adverse events
timeFrame: during 7 days follow-up post-ablation
measure: Total Fluoroscopy exposure time
timeFrame: at the time of the ablation procedure
measure: Total Fluoroscopy Dose-Area Product/Source Intensifier Distance
timeFrame: at the time of the ablation procedure
measure: Incidence of any phrenic nerve paralysis
timeFrame: through 1 year follow-up post-ablation
measure: Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA)
timeFrame: through 1 year follow-up post-ablation
measure: Number of mapping and ablation catheters used per subject
timeFrame: through 1 year follow-up post-ablation
measure: Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment
timeFrame: Baseline, 3, 6 and 12 months
measure: Total procedure hospital visit and ablation procedure costs
timeFrame: during hospitalization stay for study treatment
measure: Total number of initial or prolonged hospitalizations and unscheduled arrhythmia-related health care provider visits (including emergency department visits)
timeFrame: through 1 year follow-up post-ablation
Other outcomes:
Locations:
Study officials:
affiliation: A.Z. St Jan AV
name: Mattias Duytschaever, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: A.Z. Middelheim
name: Yves De Greef, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Essex Cardiothoracic Centre
name: Stuart Harris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Varde
name: Peter Steen Hansen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis
name: Pepijn Van Der Voort, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Krankenhaus Porz Cologne
name: Thomas Deneke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southlake Regional Health Centre
name: Atul Verma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Isala
name: Arif Elvan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southlake Regional Health Centre
name: Yaariv Khaykin, MD
role: PRINCIPAL_INVESTIGATOR
References: