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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01116557
Other study ID # BWI130
Secondary ID
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


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
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