Trial Outcomes & Findings for First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study) (NCT NCT00392054)

NCT ID: NCT00392054

Last Updated: 2020-01-31

Results Overview

Recurrence of electrocardiographically documented atrial fibrillation, atrial flutter or atrial tachycardia lasting \>30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

127 participants

Primary outcome timeframe

Assessed during 21 month follow-up period

Results posted on

2020-01-31

Participant Flow

Eligible consenting patients from 16 sites in Canada and Europe were randomly assigned 1:1 to the Catheter Ablation arm or Antiarrythmic Drug Therapy arm. The randomization schedule was computer generated and stratified by site with variable block size.

Participant milestones

Participant milestones
Measure	Catheter Ablation Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation	Antiarrhythmic Drug Therapy Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation
Overall Study STARTED	66	61
Overall Study Received Allocated Intervention	65	60
Overall Study COMPLETED	66	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Catheter Ablation n=66 Participants Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation	Antiarrhythmic Drug Therapy n=61 Participants Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation	Total n=127 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	48 Participants n=7 Participants	99 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Age, Continuous	56.3 years STANDARD_DEVIATION 9.3 • n=5 Participants	54.3 years STANDARD_DEVIATION 11.7 • n=7 Participants	55.8 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	45 Participants n=7 Participants	96 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Czech Republic	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Canada	41 participants n=5 Participants	38 participants n=7 Participants	79 participants n=5 Participants
Region of Enrollment Germany	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
Region of Enrollment Italy	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed during 21 month follow-up period

Population: All randomized patients

Outcome measures

Outcome measures
Measure	Catheter Ablation n=66 Participants First-line treatment with radiofrequency catheter ablation procedure	Antiarrhythmic Drug Therapy n=61 Participants Standard antiarrhythmic drug therapy
Number of Participants With Recurrence of Atrial Tachyarrhythmia	36 Participants	44 Participants

PRIMARY outcome

Timeframe: Assessed during entire 24 month study period

Population: All patients treated

Ablation arm cluster: death, cardiac tamponade, severe PV stenosis\>70%, atrioesophageal fistula, thromboembolism, vascular complications (i.e. arterial pseudoaneurysm, arteriovenous fistula and hematoma leading to transfusion), phrenic nerve injury or complete AV block requiring permanent pacemaker implantation. Antiarrhythmic drug arm cluster: Death, torsade de pointes, bradycardia leading to pacemaker insertion, syncope, QRS duration prolongation \> 50% of baseline, 1:1 atrial flutter or any other significant adverse events that leads to drug discontinuation.

Outcome measures

Outcome measures
Measure	Catheter Ablation n=65 Participants First-line treatment with radiofrequency catheter ablation procedure	Antiarrhythmic Drug Therapy n=61 Participants Standard antiarrhythmic drug therapy
Comparison of Proportion of Patients With an Occurrence of Any of a Cluster of Serious Complications in Either Arm	5 Participants	12 Participants

SECONDARY outcome

Timeframe: 21 months of follow-up

Population: All patients randomized

Including only symptomatic episodes of all atrial tachyarrhythmias (atrial fibrillation, atrial flutter and atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Outcome measures

Outcome measures
Measure	Catheter Ablation n=66 Participants First-line treatment with radiofrequency catheter ablation procedure	Antiarrhythmic Drug Therapy n=61 Participants Standard antiarrhythmic drug therapy
Number of Participants With Recurrence of Symptomatic Atrial Tachyarrhythmia	31 participants	36 participants

SECONDARY outcome

Timeframe: During 21 month follow-up period

Population: All patients randomized

Including only symptomatic episodes of atrial fibrillation in the outcome measure (excluding asymptomatic events and events adjudicated as atrial flutter or atrial tachycardia). The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Outcome measures

Outcome measures
Measure	Catheter Ablation n=66 Participants First-line treatment with radiofrequency catheter ablation procedure	Antiarrhythmic Drug Therapy n=61 Participants Standard antiarrhythmic drug therapy
Number of Participants With Recurrence of Symptomatic Atrial Fibrillation	27 participants	35 participants

SECONDARY outcome

Timeframe: During 21 month follow-up period

Population: All patients randomized

Including all episodes of symptomatic or asymptomatic atrial fibrillation, atrial flutter and atrial tachycardia. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Outcome measures

Outcome measures
Measure	Catheter Ablation n=3234 Number of ECGs Adjudicated First-line treatment with radiofrequency catheter ablation procedure	Antiarrhythmic Drug Therapy n=61 Participants Standard antiarrhythmic drug therapy
Episodes of ANY Recurrence of Atrial Tachyarrhythmia	213 Episodes	502 Episodes

SECONDARY outcome

Timeframe: During 21 month follow-up period

Population: All patients randomized

Including only events documented by 12 lead ECG, Holter monitoring or rhythm strips but excluding TTM monitoring. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed).

Outcome measures

Outcome measures
Measure	Catheter Ablation n=66 Participants First-line treatment with radiofrequency catheter ablation procedure	Antiarrhythmic Drug Therapy n=61 Participants Standard antiarrhythmic drug therapy
Number of Participants With Recurrence of Atrial Tachyarrhythmia Obtained Clinically	16 participants	19 participants

SECONDARY outcome

Timeframe: Measured at 12 months after randomization

Population: EQ-5D completed at 12 months

The standard EQ-5D questionnaire is completed by study participants. The EQ-5D Index score is a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Self-reported severity for each dimension is given on a 3 level scale: (1) no problems, (2) some problems or (3) major problems. For example a health state: 11223 means: no problems with mobility (1), no problems with self-care (1), some problems with performing usual activity (2), moderate pain/discomfort (2), and major anxiety/depression (3). Thus there are 243 patterns of health state: 11111 to 33333. Scores are converted to a single weighted index score (utility). The index score is derived by applying a formula as developed by Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care 2005; 43(3): 203-220. The final score has a minimum value of 0 and maximum value of 1 (no problems).

Outcome measures

Outcome measures
Measure	Catheter Ablation n=59 Participants First-line treatment with radiofrequency catheter ablation procedure	Antiarrhythmic Drug Therapy n=57 Participants Standard antiarrhythmic drug therapy
Quality of Life EQ5D Index Score	1 Index score Interval 0.84 to 1.0	1 Index score Interval 0.83 to 1.0

SECONDARY outcome

Timeframe: Measured At 12 months after randomization

Population: Participants with EQ5D VAS completed at 12 months after randomization.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The scale measures how good/bad one's own health is today, in one's own opinion. 0 means the worst imaginable state of health; 100 means the best imaginable state of health.

Outcome measures

Outcome measures
Measure	Catheter Ablation n=59 Participants First-line treatment with radiofrequency catheter ablation procedure	Antiarrhythmic Drug Therapy n=57 Participants Standard antiarrhythmic drug therapy
Quality of Life EQ-5D Visual Analog Score	85 score on a scale Interval 80.0 to 90.0	80 score on a scale Interval 75.0 to 90.0

Adverse Events

Catheter Ablation

Serious events: 6 serious events

Other events: 21 other events

Deaths: 0 deaths

Antiarrhythmic Drug Therapy

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Catheter Ablation n=65 participants at risk First-line treatment with radiofrequency catheter ablation procedure	Antiarrhythmic Drug Therapy n=60 participants at risk Standard antiarrhythmic drug therapy
Cardiac disorders Angina pectoris	1.5% 1/65 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.	0.00% 0/60 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.
Gastrointestinal disorders Diarrhoea	1.5% 1/65 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.	0.00% 0/60 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.
General disorders Chest pain	0.00% 0/65 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.	1.7% 1/60 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.
Infections and infestations Appendicitis	0.00% 0/65 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.	1.7% 1/60 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.
Injury, poisoning and procedural complications Post procedural infection	1.5% 1/65 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.	0.00% 0/60 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.
Metabolism and nutrition disorders Hyponatraemia	1.5% 1/65 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.	0.00% 0/60 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.
Injury, poisoning and procedural complications Subdural hematoma	1.5% 1/65 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.	0.00% 0/60 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.
Musculoskeletal and connective tissue disorders Bursitis	1.5% 1/65 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.	0.00% 0/60 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.
Nervous system disorders Dizziness	0.00% 0/65 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.	1.7% 1/60 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pulmonary tumor	1.5% 1/65 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.	0.00% 0/60 • Duration of follow-up from randomization until completion of follow-up, up to 24 months after randomization. Assessments occurred at 1, 3, 4, 6, 9, 12, 18 and 24 months. All SAEs (standard definitions) were reported to the central coordinating center within 24 hours of knowledge of the event. A plan was in place for expedited notification to the FDA of any unanticipated fatal or life-threatening adverse events related to either intervention. No such events occurred during study follow-up.

Other adverse events

Additional Information

Carlos A. Morillo, MD, FRCPC, FACC, FHRS, FESC, FHRS

Population Health Research Institute

Phone: 905-527-4322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place