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Study prematurely terminated due to randomization imbalance.
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The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating additional lines of block with the aid of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System. Effectiveness will be determined by comparing the chronic success of ablation therapy versus antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the first 24 months after a run-in phase of 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Catheter ablation |
|
| 2 | Active Comparator | Antiarrhythmic drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF ablation | Device | Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months). | Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions. | within first 24 months after a 2-month run-in phase |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months) | within first 24 months after a 2-month run-in phase | |
| Percentage of Procedural Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuele Bertaglia, MD | ULSS n.13, Mirano (VE), Italy | Principal Investigator |
| Giuseppe Stabile, MD | Casa di Cura San Michele, Maddaloni, Italy | Principal Investigator |
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One hundred twenty-nine (129) subjects were enrolled in the study at the time of termination. Ten of 13 study sites were in Italy, thus the majority of subjects were recruited from Italian sites. The sponsor's decision at study termination was to report primary and secondary endpoints for which meaningful data analysis was possible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Catheter Ablation | Catheter Ablation |
| FG001 | Antiarrhythmic Drug Treatment | Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Catheter Ablation | Catheter Ablation |
| BG001 | Antiarrhythmic Drug Treatment | Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months). | Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions. | Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data. | Posted | Number | percentage of participants | within first 24 months after a 2-month run-in phase |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Catheter Ablation | Catheter Ablation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| coronary angiography | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| corneal deposit of amiodarone | Eye disorders | Systematic Assessment |
The study was terminated early due to randomization imbalance. The relatively small number of subjects enrolled limited the amount of data available for analysis. Because the study did not reach its targeted enrollment, the study is underpowered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pat Ticknor, Clinical Operations | Biosense Webster, Inc. | 909-839-8500 | PTicknor@its.jnj.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000889 | Anti-Arrhythmia Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Antiarrhythmic drugs | Drug | Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study |
|
Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following:
If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success.
| The day of the procedure |
| Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase | day 61 through 790 |
| Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs | at 26 months and at each patients last follow-up visit |
| Quality of Life | at 14, 26 and 38 months |
| Health-economics Parameters (Days of Hospitalization) | at 26 months and at each patients last follow-up visit |
| Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor | at each patients last follow-up visit |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
|
| Secondary | Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months) | Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data. | Posted | Number | percentage of participants | within first 24 months after a 2-month run-in phase |
|
|
|
| Secondary | Percentage of Procedural Success | Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following:
If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success. | Procedural success was only calculated for the catheter ablation group. Intention to Treat (ITT) analysis of procedural success for the catheter ablation group was performed using available data. The "0" below the Antiarrhythmic Drug treatment group represents "not available." | Posted | Number | percentage of participants | The day of the procedure |
|
|
|
| Secondary | Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase | Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data. The upper bound of the confidence interval for the drug treatment group could not be calculated because of the high censoring rate. Therefore, "NA" is more appropriate in place of the maximum duration of follow-up (790.0) as the upper bound. | Posted | Median | 95% Confidence Interval | days | day 61 through 790 |
|
|
|
| Secondary | Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs | Study termination due to randomization imbalance. Data not analyzed since enrollment limited and therefore insufficient data to identify meaningful differences and draw significant conclusions. The "0" below represents "not available." | Posted | at 26 months and at each patients last follow-up visit |
|
|
| Secondary | Quality of Life | Study termination due to randomization imbalance. Data not analyzed since enrollment limited and therefore insufficient data to identify meaningful differences and draw significant conclusions. The "0" below represents "not available." | Posted | at 14, 26 and 38 months |
|
|
| Secondary | Health-economics Parameters (Days of Hospitalization) | Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions. | Posted | at 26 months and at each patients last follow-up visit |
|
|
| Secondary | Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor | Intention to Treat (ITT)analysis of sinus rhythm was performed for subjects with available Holter Monitor data. | Posted | Number | percentage of participants | at each patients last follow-up visit |
|
|
|
| 25 |
| 87 |
| 0 |
| 87 |
| EG001 | Antiarrhythmic Drug Treatment | Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study | 22 | 42 | 3 | 42 |
| all types of atrial flutter including, but not limited to atypical and left atrial flutter | Cardiac disorders | Systematic Assessment |
|
| worsening ventricular function | Cardiac disorders | Systematic Assessment |
|
| sinusal arrest | Cardiac disorders | Systematic Assessment |
|
| bradycardia | Cardiac disorders | Systematic Assessment |
|
| torsade de pointes | Cardiac disorders | Systematic Assessment |
|
| heart failure | Cardiac disorders | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| low hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| lipotimia and hyperkaliemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| hyperthyroidism | Endocrine disorders | Systematic Assessment |
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| reduced visual acuity secondary to cataract | Eye disorders | Systematic Assessment |
|
| sudden death | General disorders | Systematic Assessment |
|
| lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| increased tumor size | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| tremens | Nervous system disorders | Systematic Assessment |
|
| renal failure | Renal and urinary disorders | Systematic Assessment |
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| hemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ablate and pace procedure | Surgical and medical procedures | Systematic Assessment |
|
| silent ischemic heart disease | Cardiac disorders | Systematic Assessment |
|
| carotid atrery stenosis | Vascular disorders | Systematic Assessment |
|
| sinus pause | Cardiac disorders | Systematic Assessment |
|
| dyspnea | Cardiac disorders | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| diabetes | Endocrine disorders | Systematic Assessment |
|
| colon polyp | Gastrointestinal disorders | Systematic Assessment |
|
| cardiac tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
|
| inguinal hernia | Injury, poisoning and procedural complications | Systematic Assessment |
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| cerebral aneurism | Injury, poisoning and procedural complications | Systematic Assessment |
|
| right knee trauma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| brain injury secondary to facial trauma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| genital-urinary area neoplastic mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| nasal bleeding | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pacemaker implantation | Surgical and medical procedures | Systematic Assessment |
|
| atrioventricular node ablation | Surgical and medical procedures | Systematic Assessment |
|
| transient ischemic attack | Vascular disorders | Systematic Assessment |
|
| artero-venious fistula | Injury, poisoning and procedural complications | Systematic Assessment |
|
There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
| D013568 |
| Pathological Conditions, Signs and Symptoms |