Trial Outcomes & Findings for Tailored Treatment of Permanent Atrial Fibrillation (NCT NCT00514735)

Last Updated: 2018-10-16

Results Overview

The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included: 1. A 90% reduction in clinically significant atrial fibrillation from baseline to the 6 month time point based on a Holter recording. Clinically significant atrial fibrillation was defined as sustained atrial fibrillation lasting more than 10 minutes. 2. The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only) 3. The Investigator judged all procedures to be acutely successful (Ablation Management arm only).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

210 participants

Primary outcome timeframe

6 months

Results posted on

2018-10-16

Participant Flow

The first subject was enrolled on November 28, 2007. The very last ablation procedure was a retreatment ablation procedure for a Medical Management Crossover subject that occurred on May 7, 2010 with the final follow-up on November 1, 2010.

32 subjects signed Informed Consent forms but withdrew from the study prior to randomization. * 24 failed to meet inclusion/exclusion criteria * 6 elected to withdraw * 1 subject was withdrawn by the Sponsor after being consented. * 1 subject was withdrawn as screening was incomplete prior to closing enrollment for the study

Participant milestones

Participant milestones
Measure	Ablation Management Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Overall Study STARTED	138	72
Overall Study COMPLETED	124	66
Overall Study NOT COMPLETED	14	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ablation Management Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Overall Study Withdrawal by Subject	13	5
Overall Study Death	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Tailored Treatment of Permanent Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ablation Management n=138 Participants Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management n=72 Participants Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.	Total n=210 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	93 Participants n=5 Participants	43 Participants n=7 Participants	136 Participants n=5 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants	29 Participants n=7 Participants	74 Participants n=5 Participants
Age, Continuous	59.6 years STANDARD_DEVIATION 8.3 • n=5 Participants	60.7 years STANDARD_DEVIATION 8.9 • n=7 Participants	60.0 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	12 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	115 Participants n=5 Participants	60 Participants n=7 Participants	175 Participants n=5 Participants
Region of Enrollment United States	126 participants n=5 Participants	65 participants n=7 Participants	191 participants n=5 Participants
Region of Enrollment Netherlands	12 participants n=5 Participants	7 participants n=7 Participants	19 participants n=5 Participants
Number of DC cardioversions in past 4 years	2.0 cardioversions STANDARD_DEVIATION 1.1 • n=5 Participants	2.4 cardioversions STANDARD_DEVIATION 3.5 • n=7 Participants	2.1 cardioversions STANDARD_DEVIATION 2.2 • n=5 Participants
Number of previously failed AADs per subject	1.4 antiarrhythmic drugs STANDARD_DEVIATION 0.6 • n=5 Participants	1.1 antiarrhythmic drugs STANDARD_DEVIATION 0.4 • n=7 Participants	1.3 antiarrhythmic drugs STANDARD_DEVIATION 0.6 • n=5 Participants
Left Atrial Diameter	4.5 centimeters STANDARD_DEVIATION 0.5 • n=5 Participants	4.6 centimeters STANDARD_DEVIATION 0.5 • n=7 Participants	4.6 centimeters STANDARD_DEVIATION 0.5 • n=5 Participants
Left Ventricular Ejection Fraction	54.7 percent STANDARD_DEVIATION 7.1 • n=5 Participants	54.9 percent STANDARD_DEVIATION 6.7 • n=7 Participants	54.7 percent STANDARD_DEVIATION 7.0 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group. The primary missing value imputation technique for all primary endpoint analyses was the passive method of imputation.

Outcome measures

Outcome measures
Measure	Ablation Management n=138 Participants Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management n=72 Participants Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Chronic Effectiveness	56 percentage of participants with success	26 percentage of participants with success

PRIMARY outcome

Timeframe: 7 days

Population: An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group.

The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.

Outcome measures

Outcome measures
Measure	Ablation Management n=138 Participants Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Acute Safety	12.3 percentage of participants Interval 7.3 to 19.0	—

PRIMARY outcome

Timeframe: 6 months

The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.

Outcome measures

Outcome measures
Measure	Ablation Management n=138 Participants Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management n=72 Participants Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Chronic Safety	9 participants	3 participants

SECONDARY outcome

Timeframe: Procedure conclusion

A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true: * Medtronic ablation catheters were used to achieve procedure success. * All accessible pulmonary veins were isolated. * At least 50% reduction of complex fractionated atrial electrograms mapped and ablated with Medtronic ablation catheters. * Sinus rhythm was achieved upon leaving the electrophysiology lab (±cardioversion).

Outcome measures

Outcome measures
Measure	Ablation Management n=138 Participants Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Acute Efficacy	92.8 percentage of participants Interval 87.0 to 96.0	—

SECONDARY outcome

Timeframe: 6 months

Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms.

Outcome measures

Outcome measures
Measure	Ablation Management n=138 Participants Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management n=72 Participants Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Improvement of Left Atrial Size at 6 Months Compared to Baseline. Measurement at Baseline	4.5 centimeters Standard Deviation 0.53	4.6 centimeters Standard Deviation 0.49
Improvement of Left Atrial Size at 6 Months Compared to Baseline. Measurement at 6 Months	4.4 centimeters Standard Deviation 0.67	4.6 centimeters Standard Deviation 0.56

SECONDARY outcome

Timeframe: 6 months

Population: An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group.

Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.

Outcome measures

Outcome measures
Measure	Ablation Management n=138 Participants Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management n=72 Participants Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline. Measurement at Baseline	54.7 percent Standard Deviation 7.09	54.9 percent Standard Deviation 6.73
Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline. Measurement at 6 Months	58.3 percent Standard Deviation 6.73	57.0 percent Standard Deviation 6.06

SECONDARY outcome

Timeframe: 6 months

Population: An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group.

The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe). The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise. The scores were tabulated at the 1, 3 and 6 month follow-up visits. Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic.

Outcome measures

Outcome measures
Measure	Ablation Management n=138 Participants Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management n=72 Participants Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline. Measurement at Baseline	12.38 AF Symptom Severity Score Standard Deviation 4.21	12.72 AF Symptom Severity Score Standard Deviation 4.47
Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline. Measurement at 1 Month	8.95 AF Symptom Severity Score Standard Deviation 3.58	9.90 AF Symptom Severity Score Standard Deviation 3.85
Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline. Measurement at 3 Months	7.56 AF Symptom Severity Score Standard Deviation 2.97	10.03 AF Symptom Severity Score Standard Deviation 3.89
Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline. Measurement at 6 Months	7.58 AF Symptom Severity Score Standard Deviation 3.53	9.84 AF Symptom Severity Score Standard Deviation 4.34

SECONDARY outcome

Timeframe: 6 months

Population: An Intention to Treat (ITT) analysis was performed in which all data was analyzed according to the subject's assigned randomization group.

The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score. The possible range for Physical Component Score and Mental Component Score is 0 to 100. The higher score, the better quality of life.

Outcome measures

Outcome measures
Measure	Ablation Management n=138 Participants Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management n=72 Participants Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Improved Quality of Life Over 6 Months Compared to Baseline. Physical Component Score at Baseline	42.54 Scores on a scale Standard Deviation 10.45	42.26 Scores on a scale Standard Deviation 9.85
Improved Quality of Life Over 6 Months Compared to Baseline. Physical Component Score at 1 Month	45.61 Scores on a scale Standard Deviation 9.98	43.05 Scores on a scale Standard Deviation 10.46
Improved Quality of Life Over 6 Months Compared to Baseline. Physical Component Score at 3 Months	48.30 Scores on a scale Standard Deviation 9.76	43.99 Scores on a scale Standard Deviation 9.97
Improved Quality of Life Over 6 Months Compared to Baseline. Physical Component Score at 6 Months	49.12 Scores on a scale Standard Deviation 9.56	44.98 Scores on a scale Standard Deviation 9.59
Improved Quality of Life Over 6 Months Compared to Baseline. Mental Component Score at Baseline	47.19 Scores on a scale Standard Deviation 11.02	47.99 Scores on a scale Standard Deviation 12.13
Improved Quality of Life Over 6 Months Compared to Baseline. Mental Component Score at 1 Month	51.53 Scores on a scale Standard Deviation 10.34	48.96 Scores on a scale Standard Deviation 11.54
Improved Quality of Life Over 6 Months Compared to Baseline. Mental Component Score at 3 Months	53.42 Scores on a scale Standard Deviation 9.27	48.97 Scores on a scale Standard Deviation 10.52
Improved Quality of Life Over 6 Months Compared to Baseline. Mental Component Score at 6 Months	53.45 Scores on a scale Standard Deviation 9.07	50.06 Scores on a scale Standard Deviation 11.26

Adverse Events

Ablation Management

Serious events: 41 serious events

Other events: 25 other events

Deaths: 0 deaths

Medical Management

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ablation Management n=138 participants at risk Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.	Medical Management n=72 participants at risk Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
Blood and lymphatic system disorders hematoma	11.6% 16/138 • Number of events 18 • Adverse events (AEs) were collected from the day of randomization to trial conclusion at the final 6 month follow-up. All adverse events were included even if the subject had a repeat procedure and the 6 month follow-up period was restarted. All adverse events (serious and nonserious) were recorded. Specific data about the event were entered into the electronic database. A planned hospital admission or unscheduled medical visit for atrial fibrillation that occurred within the follow-up period did not constitute an adverse event.	0.00% 0/72 • Adverse events (AEs) were collected from the day of randomization to trial conclusion at the final 6 month follow-up. All adverse events were included even if the subject had a repeat procedure and the 6 month follow-up period was restarted. All adverse events (serious and nonserious) were recorded. Specific data about the event were entered into the electronic database. A planned hospital admission or unscheduled medical visit for atrial fibrillation that occurred within the follow-up period did not constitute an adverse event.
General disorders chest pain	6.5% 9/138 • Number of events 10 • Adverse events (AEs) were collected from the day of randomization to trial conclusion at the final 6 month follow-up. All adverse events were included even if the subject had a repeat procedure and the 6 month follow-up period was restarted. All adverse events (serious and nonserious) were recorded. Specific data about the event were entered into the electronic database. A planned hospital admission or unscheduled medical visit for atrial fibrillation that occurred within the follow-up period did not constitute an adverse event.	0.00% 0/72 • Adverse events (AEs) were collected from the day of randomization to trial conclusion at the final 6 month follow-up. All adverse events were included even if the subject had a repeat procedure and the 6 month follow-up period was restarted. All adverse events (serious and nonserious) were recorded. Specific data about the event were entered into the electronic database. A planned hospital admission or unscheduled medical visit for atrial fibrillation that occurred within the follow-up period did not constitute an adverse event.
Cardiac disorders bradycardia	0.00% 0/138 • Adverse events (AEs) were collected from the day of randomization to trial conclusion at the final 6 month follow-up. All adverse events were included even if the subject had a repeat procedure and the 6 month follow-up period was restarted. All adverse events (serious and nonserious) were recorded. Specific data about the event were entered into the electronic database. A planned hospital admission or unscheduled medical visit for atrial fibrillation that occurred within the follow-up period did not constitute an adverse event.	4.2% 3/72 • Number of events 3 • Adverse events (AEs) were collected from the day of randomization to trial conclusion at the final 6 month follow-up. All adverse events were included even if the subject had a repeat procedure and the 6 month follow-up period was restarted. All adverse events (serious and nonserious) were recorded. Specific data about the event were entered into the electronic database. A planned hospital admission or unscheduled medical visit for atrial fibrillation that occurred within the follow-up period did not constitute an adverse event.

Additional Information

Linda Nelson, Director of Clinical Research

Medtronic

Phone: 763-526-2891

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place