Trial Outcomes & Findings for CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation (NCT NCT00227344)
NCT ID: NCT00227344
Last Updated: 2025-02-04
Results Overview
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.
TERMINATED
PHASE4
129 participants
within first 24 months after a 2-month run-in phase
2025-02-04
Participant Flow
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.
Participant milestones
| Measure |
Catheter Ablation
Catheter Ablation
|
Antiarrhythmic Drug Treatment
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
42
|
|
Overall Study
COMPLETED
|
75
|
37
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
| Measure |
Catheter Ablation
Catheter Ablation
|
Antiarrhythmic Drug Treatment
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
|---|---|---|
|
Overall Study
study terminated early
|
12
|
5
|
Baseline Characteristics
CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Catheter Ablation
n=87 Participants
Catheter Ablation
|
Antiarrhythmic Drug Treatment
n=42 Participants
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
64.3 years
STANDARD_DEVIATION 4.7 • n=107 Participants
|
59.6 years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: within first 24 months after a 2-month run-in phasePopulation: Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.
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.
Outcome measures
| Measure |
Catheter Ablation
n=75 Participants
Catheter Ablation
|
Antiarrhythmic Drug Treatment
n=37 Participants
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
|---|---|---|
|
Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).
|
36.0 percentage of participants
|
45.9 percentage of participants
|
SECONDARY outcome
Timeframe: within first 24 months after a 2-month run-in phasePopulation: Intention to treat (ITT) analysis includes subjects with available transtelephonic monitoring data.
Outcome measures
| Measure |
Catheter Ablation
n=75 Participants
Catheter Ablation
|
Antiarrhythmic Drug Treatment
n=37 Participants
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
|---|---|---|
|
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)
|
16.0 percentage of participants
|
24.3 percentage of participants
|
SECONDARY outcome
Timeframe: The day of the procedurePopulation: 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."
Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following: 1. "Has a validation of the lesions been performed by taking 3 points inside each circular lesion?" 2. "If YES to #1, did you observe that none of them exceed 0.1 mV?" 3. "Did you observe any adverse event during the procedure?" If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success.
Outcome measures
| Measure |
Catheter Ablation
n=84 Participants
Catheter Ablation
|
Antiarrhythmic Drug Treatment
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
|---|---|---|
|
Percentage of Procedural Success
|
70.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: day 61 through 790Population: 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.
Outcome measures
| Measure |
Catheter Ablation
n=75 Participants
Catheter Ablation
|
Antiarrhythmic Drug Treatment
n=36 Participants
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
|---|---|---|
|
Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase
|
302.0 days
Interval 133.0 to 436.0
|
328.0 days
Interval 165.0 to
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.
|
SECONDARY outcome
Timeframe: at 26 months and at each patients last follow-up visitPopulation: 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."
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 14, 26 and 38 monthsPopulation: 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."
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 26 months and at each patients last follow-up visitPopulation: Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at each patients last follow-up visitPopulation: Intention to Treat (ITT)analysis of sinus rhythm was performed for subjects with available Holter Monitor data.
Outcome measures
| Measure |
Catheter Ablation
n=82 Participants
Catheter Ablation
|
Antiarrhythmic Drug Treatment
n=39 Participants
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
|---|---|---|
|
Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor
|
75.6 percentage of participants
|
51.3 percentage of participants
|
Adverse Events
Catheter Ablation
Antiarrhythmic Drug Treatment
Serious adverse events
| Measure |
Catheter Ablation
n=87 participants at risk
Catheter Ablation
|
Antiarrhythmic Drug Treatment
n=42 participants at risk
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
|---|---|---|
|
Cardiac disorders
coronary angiography
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
all types of atrial flutter including, but not limited to atypical and left atrial flutter
|
3.4%
3/87 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
worsening ventricular function
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
sinusal arrest
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
bradycardia
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
torsade de pointes
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
heart failure
|
2.3%
2/87 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
low hemoglobin
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
lipotimia and hyperkaliemia
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Endocrine disorders
hyperthyroidism
|
0.00%
0/87
|
4.8%
2/42 • Number of events 2
|
|
Eye disorders
reduced visual acuity secondary to cataract
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
General disorders
sudden death
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
increased tumor size
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
tremens
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Surgical and medical procedures
ablate and pace procedure
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
silent ischemic heart disease
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Vascular disorders
carotid atrery stenosis
|
0.00%
0/87
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
sinus pause
|
2.3%
2/87 • Number of events 2
|
0.00%
0/42
|
|
Cardiac disorders
dyspnea
|
2.3%
2/87 • Number of events 2
|
0.00%
0/42
|
|
Cardiac disorders
myocardial infarction
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Endocrine disorders
diabetes
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
colon polyp
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
cardiac tamponade
|
2.3%
2/87 • Number of events 2
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
inguinal hernia
|
2.3%
2/87 • Number of events 2
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
cerebral aneurism
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
right knee trauma
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
brain injury secondary to facial trauma
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
genital-urinary area neoplastic mass
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
nasal bleeding
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Surgical and medical procedures
pacemaker implantation
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Surgical and medical procedures
atrioventricular node ablation
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Vascular disorders
transient ischemic attack
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
|
Injury, poisoning and procedural complications
artero-venious fistula
|
1.1%
1/87 • Number of events 1
|
0.00%
0/42
|
Other adverse events
| Measure |
Catheter Ablation
n=87 participants at risk
Catheter Ablation
|
Antiarrhythmic Drug Treatment
n=42 participants at risk
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
|
|---|---|---|
|
Eye disorders
corneal deposit of amiodarone
|
0.00%
0/87
|
7.1%
3/42 • Number of events 3
|
Additional Information
Pat Ticknor, Clinical Operations
Biosense Webster, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER