Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes
Brief summary
The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.
Detailed description
Eligible PAF subjects with recurrent AF for 2 years who have failed no more than 2 prescribed drugs (with either anti-arrhythmic or rate control drug) are randomized into one of two study arms (catheter ablation or drug therapy).
Interventions
DEVICECatheter Ablation
Treat subjects with Paroxysmal Atrial Fibrillation (PAF)
DRUGDrug Treatment
Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.
Sponsors
Biosense Webster, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with ≥ 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous 6 episodes ) 2. HATCH Score of at least ≥1 and ≤4. 3. Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug). 4. Age 60 years or older. 5. Left atrium (LA) diameter ≤ 55mm by TTE. 6. Left ventricle (LV) ejection fraction ≥50% when in sinus rhythm or LV ejection fraction ≥35% when in atrial fibrillation. NOTE: For patients entering the study in AF with an ejection fraction ≥35% and \<50%; the ejection fraction should be re-checked when in sinus rhythm. In case the ejection fraction is \>50% the subject can continue in the study. 7. Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow-up testing.
Exclusion criteria
1. Patients awaiting cardiac transplantation or other cardiac surgery. 2. Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study. 3. Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma, etc. 4. Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months. 5. Heart failure decompensation. 6. Previously diagnosed with persistent/permanent atrial fibrillation/ atrial flutter. 7. Previously required cardioversion \>48 hours after onset of atrial fibrillation/ atrial flutter. 8. Subject having previous transischemic attack (TIA) or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery. 9. Pulmonary embolism or recent atrial embolism/thrombosis. 10. Hypertrophic obstructive cardiomyopathy. 11. Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation). 12. Mandated anti-arrhythmic drug therapy for disease conditions other than atrial fibrillation. 13. Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs. 14. Prior left atrial catheter ablation with the intention of treating atrial fibrillation; prior surgical interventions for AF such as the MAZE procedure. 15. Prior AV nodal ablation. 16. Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use. 17. Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications. 18. Medical conditions limiting expected survival to \<3 years. 19. Concurrent participation in any other clinical study. 20. Prior history of non-adherence to prescribed drug regimens. 21. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial NOTE: Prior ablation of the cavo-tricuspid isthmus is not a reason to exclude, if the patient develops subsequent recurrent atrial fibrillation. NOTE: For patients randomized to the PVI group (Test Group), a Transesophageal Echocardiography (TEE) should be performed (as per standard of care), within 48 hours pre-procedure, to exclude atrial thrombus or other structural contraindications for an ablation procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years | 3 years | Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years | 2 years | Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. |
| Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year | 1 year | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. |
| Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years | 2 Years | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. |
| Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year | 3 year | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. |
| Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year | 1 year | Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. |
| Number of Repeat Ablations | 3 years | Number of repeat ablations refers to the total number of ablation procedures (including initial ablation procedure). If the number of repeat ablations =1 then subject only had one ablation procedure (initial ablation procedure in test group as randomized or cross-over procedure in cross-over subjects). If the number of repeat ablations is \>= 2, then subject had at least one repeat procedure. |
| Number of New Antiarrhythmic Drugs | 3 years | Number of new antiarrhythmic drugs were administered as per investigator's discretion and 2006 AF management guidelines. |
| Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 3 months, 6 months, 1 year, 2 years, 3 years | Subject in sinus rhythm: no other rhythms documented at specific visit, based on ECG, Holter and event recorder. Percentages are calculated with respect to number of subjects with data available at corresponding visit |
| Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 3 months, 6 months, 1 year, 2 year and 3 years | Subjects with recurrent AF/AT: any AF/AT documented between previous visit up to visit analyzed at any TTM, Holter or ECG. Percentages are calculated with respect to number of subjects with data available at corresponding visit |
| Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations | 3 years | Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year by number of repeat ablations were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. |
Participant flow
Recruitment details
The first subject was enrolled on 13-Feb-2012. On 27-Feb-2018, study was terminated early due to enrollment not proceeding in accordance with expectations, independently from the study outcome. The last subject completed the last visit on 29-May-2018.
Pre-assignment details
Before randomization and signing inform consent forms, all subjects were screened according protocol defined inclusion and exclusion criteria. Screening failures were excluded from the study and were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency (RF) Ablation Treatment Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™). | 128 |
| Antiarrhythmic Drug (AAD) Therapy Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Participants who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment). | 127 |
| Total | 255 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 5 | 4 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Other | 0 | 2 |
| Overall Study | Sponsor closing the study | 51 | 50 |
| Overall Study | Subject discontinued | 1 | 2 |
| Overall Study | Subject excluded | 5 | 3 |
| Overall Study | Subject withdrew consent | 14 | 9 |
Baseline characteristics
| Characteristic | Radiofrequency (RF) Ablation Treatment | Antiarrhythmic Drug (AAD) Therapy | Total |
|---|---|---|---|
| Age, Continuous | 67.8 Year STANDARD_DEVIATION 4.83 | 67.6 Year STANDARD_DEVIATION 4.64 | 67.7 Year STANDARD_DEVIATION 4.73 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 74 Participants | 74 Participants | 148 Participants |
| Sex: Female, Male Male | 54 Participants | 53 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 102 | 4 / 108 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 37 / 102 | 43 / 108 | 6 / 15 | 4 / 15 |
| serious Total, serious adverse events | 38 / 102 | 30 / 108 | 7 / 15 | 4 / 15 |
Outcome results
Primary
Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time frame: 3 years
Population: Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years | NA Months |
| Antiarrhythmic Drug (AAD) Therapy | Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years | NA Months |
p-value: 0.0009Log Rank
Secondary
Number of New Antiarrhythmic Drugs
Number of new antiarrhythmic drugs were administered as per investigator's discretion and 2006 AF management guidelines.
Time frame: 3 years
Population: Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Number of New Antiarrhythmic Drugs | 0.8 AAD drug | Standard Deviation 1.05 |
| Antiarrhythmic Drug (AAD) Therapy | Number of New Antiarrhythmic Drugs | 1.0 AAD drug | Standard Deviation 1.23 |
Secondary
Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up
Subject in sinus rhythm: no other rhythms documented at specific visit, based on ECG, Holter and event recorder. Percentages are calculated with respect to number of subjects with data available at corresponding visit
Time frame: 3 months, 6 months, 1 year, 2 years, 3 years
Population: Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. The number of participants analyzed at each visit is the number of participants with available data at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 6 month follow up | 49 Participants |
| Radiofrequency (RF) Ablation Treatment | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 2 year follow up | 37 Participants |
| Radiofrequency (RF) Ablation Treatment | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 1 year follow up | 41 Participants |
| Radiofrequency (RF) Ablation Treatment | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 3 year follow up | 20 Participants |
| Radiofrequency (RF) Ablation Treatment | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 3 month follow up | 51 Participants |
| Antiarrhythmic Drug (AAD) Therapy | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 3 year follow up | 23 Participants |
| Antiarrhythmic Drug (AAD) Therapy | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 3 month follow up | 55 Participants |
| Antiarrhythmic Drug (AAD) Therapy | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 6 month follow up | 42 Participants |
| Antiarrhythmic Drug (AAD) Therapy | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 1 year follow up | 35 Participants |
| Antiarrhythmic Drug (AAD) Therapy | Number of Participants in Sinus Rhythm at Each Visit Throughout the Follow-up | 2 year follow up | 30 Participants |
Secondary
Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up
Subjects with recurrent AF/AT: any AF/AT documented between previous visit up to visit analyzed at any TTM, Holter or ECG. Percentages are calculated with respect to number of subjects with data available at corresponding visit
Time frame: 3 months, 6 months, 1 year, 2 year and 3 years
Population: Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. The number of participants analyzed at each visit is the number of participants with available data at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 2 year follow up | 16 Participants |
| Radiofrequency (RF) Ablation Treatment | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 1 year follow up | 20 Participants |
| Radiofrequency (RF) Ablation Treatment | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 3 month follow up | 17 Participants |
| Radiofrequency (RF) Ablation Treatment | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 6 month follow up | 17 Participants |
| Radiofrequency (RF) Ablation Treatment | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 3 year follow up | 10 Participants |
| Antiarrhythmic Drug (AAD) Therapy | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 3 year follow up | 17 Participants |
| Antiarrhythmic Drug (AAD) Therapy | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 3 month follow up | 20 Participants |
| Antiarrhythmic Drug (AAD) Therapy | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 6 month follow up | 45 Participants |
| Antiarrhythmic Drug (AAD) Therapy | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 1 year follow up | 38 Participants |
| Antiarrhythmic Drug (AAD) Therapy | Number of Participants With Recurrent AF/AT at Each Visit Throughout the Follow-up | 2 year follow up | 30 Participants |
Secondary
Number of Repeat Ablations
Number of repeat ablations refers to the total number of ablation procedures (including initial ablation procedure). If the number of repeat ablations =1 then subject only had one ablation procedure (initial ablation procedure in test group as randomized or cross-over procedure in cross-over subjects). If the number of repeat ablations is \>= 2, then subject had at least one repeat procedure.
Time frame: 3 years
Population: Subjects in the Intent to treat population (ITT) who were randomized to RF ablation or who received any RF ablations as Cross-Over Patients randomized to AAD group. ITT population includes all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Number of Repeat Ablations | 0.9 Event of ablation | Standard Deviation 0.57 |
| Antiarrhythmic Drug (AAD) Therapy | Number of Repeat Ablations | 1.1 Event of ablation | Standard Deviation 0.26 |
Secondary
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time frame: 1 year
Population: ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year | 1.3 Percentage of Participants |
| Antiarrhythmic Drug (AAD) Therapy | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year | 6.5 Percentage of Participants |
Secondary
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time frame: 2 Years
Population: ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years | 2.4 Percentage of participants |
| Antiarrhythmic Drug (AAD) Therapy | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years | 12.4 Percentage of participants |
Secondary
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time frame: 3 year
Population: ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year | 2.4 Percentage of Participants |
| Antiarrhythmic Drug (AAD) Therapy | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year | 17.5 Percentage of Participants |
Secondary
Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations
Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year by number of repeat ablations were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time frame: 3 years
Population: Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. Endpoint applicable only to subjects randomized into the test group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations | Number of ablations = 0 | 0.0 Percentage of participants |
| Radiofrequency (RF) Ablation Treatment | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations | Number of ablations = 1 | 1.5 Percentage of participants |
| Radiofrequency (RF) Ablation Treatment | Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations | 2 or more ablations | 7.7 Percentage of participants |
Secondary
Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time frame: 1 year
Population: Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year | NA Months |
| Antiarrhythmic Drug (AAD) Therapy | Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year | NA Months |
p-value: 0.0118Log Rank
Secondary
Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years
Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.
Time frame: 2 years
Population: Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency (RF) Ablation Treatment | Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years | NA Months |
| Antiarrhythmic Drug (AAD) Therapy | Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years | NA Months |
p-value: 0.0041Log Rank