Trial Outcomes & Findings for Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients (NCT NCT00703157)

Last Updated: 2017-05-16

Results Overview

AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.

Recruitment status

TERMINATED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

Baseline through 3-6 months post-ablation

Results posted on

2017-05-16

Participant Flow

Eighty (80) subjects were enrolled, of whom 52 were randomized. A Reveal XT Implantable device was implanted in all subjects after Informed Consent. The subjects were followed for a minimum of 1 week and a maximum of 6 months. If the subject demonstrated a minimum of 10% AF burden during this period and had complaints, the subject was randomized.

Participant milestones

Participant milestones
Measure	Catheter Catheter Ablation	Surgery Surgical Ablation
Overall Study STARTED	26	26
Overall Study 6 Months FU	25	25
Overall Study 24 Months FU	22	24
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Catheter Catheter Ablation	Surgery Surgical Ablation
Overall Study Lost to Follow-up	0	1
Overall Study source data permanently lost/ other	4	1

Baseline Characteristics

Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Catheter n=26 Participants Catheter Ablation	Surgery n=26 Participants Surgical Ablation	Total n=52 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 7 • n=5 Participants	55 years STANDARD_DEVIATION 9 • n=7 Participants	58 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
NYHA Class I	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
NYHA Class II	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 3-6 months post-ablation

AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.

Outcome measures

Outcome measures
Measure	Catheter n=24 Participants Catheter Ablation	Surgery n=26 Participants Surgical Ablation	All Subjects n=50 Participants All Subjects, regardless of randomization group
Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device. Pre-ablation	7.6 percentage of time in AF Standard Deviation 7.4	7.9 percentage of time in AF Standard Deviation 8.7	7.8 percentage of time in AF Standard Deviation 8.0
Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device. Blanking Period	1.6 percentage of time in AF Standard Deviation 4.2	3.6 percentage of time in AF Standard Deviation 6.1	2.6 percentage of time in AF Standard Deviation 5.3
Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device. Absolute Change Pre to Blanking	-6.0 percentage of time in AF Standard Deviation 6.1	-4.3 percentage of time in AF Standard Deviation 7.2	-5.1 percentage of time in AF Standard Deviation 6.7
Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device. Post-Ablation	0.5 percentage of time in AF Standard Deviation 1.4	2.0 percentage of time in AF Standard Deviation 5.5	1.3 percentage of time in AF Standard Deviation 4.1
Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device. Absolute Change Blanking to Post	-1.1 percentage of time in AF Standard Deviation 3.2	-1.1 percentage of time in AF Standard Deviation 5.5	-1.3 percentage of time in AF Standard Deviation 4.5
Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device. Percent Change Pre to Post	-77.8 percentage of time in AF Standard Deviation 68.4	-70.8 percentage of time in AF Standard Deviation 65.1	-74.2 percentage of time in AF Standard Deviation 66.1
Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device. Absolute Change Pre to Post	-7.1 percentage of time in AF Standard Deviation 7.1	-5.8 percentage of time in AF Standard Deviation 9.1	-6.5 percentage of time in AF Standard Deviation 8.1

SECONDARY outcome

Timeframe: Time from procedure until 6 months post-ablation

Outcome measures

Outcome measures
Measure	Catheter n=26 Participants Catheter Ablation	Surgery n=26 Participants Surgical Ablation	All Subjects n=52 Participants All Subjects, regardless of randomization group
Treatment Failures Requiring Redo or Alternative Therapy	5 Participants	0 Participants	5 Participants

SECONDARY outcome

Timeframe: Time from procedure

Outcome measures

Outcome measures
Measure	Catheter n=26 Participants Catheter Ablation	Surgery n=26 Participants Surgical Ablation	All Subjects n=52 Participants All Subjects, regardless of randomization group
Number of Subjects With Adverse Events, Associated With the Ablation Procedure	5 Participants	16 Participants	21 Participants

SECONDARY outcome

Timeframe: Time from procedure until 24 months post-ablation

Outcome measures

Outcome measures
Measure	Catheter n=26 Participants Catheter Ablation	Surgery n=26 Participants Surgical Ablation	All Subjects n=52 Participants All Subjects, regardless of randomization group
Mortality and Hospitalization Any Hospitalization	24 participants	31 participants	55 participants
Mortality and Hospitalization Any Procedure-Related Hospitalization	5 participants	9 participants	14 participants
Mortality and Hospitalization Death	0 participants	1 participants	1 participants

Adverse Events

Catheter

Serious events: 10 serious events

Other events: 3 other events

Deaths: 0 deaths

Surgery

Serious events: 15 serious events

Other events: 8 other events

Deaths: 1 deaths

All Randomized Subjects

Serious events: 25 serious events

Other events: 11 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Catheter n=26 participants at risk Catheter Ablation	Surgery n=26 participants at risk Surgical Ablation	All Randomized Subjects n=52 participants at risk All Randomized Subjects, regardless of randomization group
Cardiac disorders Atrial Fibrillation	11.5% 3/26 • Number of events 5 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	23.1% 6/26 • Number of events 6 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	17.3% 9/52 • Number of events 11 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Cardiac disorders Pericarditis	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	7.7% 2/26 • Number of events 2 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 2/52 • Number of events 2 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group

Additional Information

Ber Kleijnen

Medtronic Bakken Research Center, Coronary and Structural Heart Disease Management

Phone: +31 (0) 43 356 6566

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Catheter n=26 participants at risk Catheter Ablation	Surgery n=26 participants at risk Surgical Ablation	All Randomized Subjects n=52 participants at risk All Randomized Subjects, regardless of randomization group
Cardiac disorders Atrial Fibrillation	19.2% 5/26 • Number of events 9 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	11.5% 6/52 • Number of events 10 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Nervous system disorders Cerebralvascular accident	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 2/52 • Number of events 2 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
General disorders Pyrexia	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 2/52 • Number of events 2 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Injury, poisoning and procedural complications Arteriospasm coronary	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Injury, poisoning and procedural complications Cardiac procedure complication	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	7.7% 2/26 • Number of events 3 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	5.8% 3/52 • Number of events 4 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
General disorders Chest Pain	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	7.7% 2/26 • Number of events 2 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 2/52 • Number of events 2 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Surgical and medical procedures External Cephalic Version	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Nervous system disorders Parapalegia	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Surgical and medical procedures Cardiac ablation	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 2/52 • Number of events 2 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Nervous system disorders Hypoaesthesia	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Cardiac disorders Pericardial effusion	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Cardiac disorders Pericarditis	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	7.7% 2/26 • Number of events 2 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 2/52 • Number of events 2 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Eye disorders Blindness transient	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Cardiac disorders Dressler's syndrome	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
General disorders General physical health deterioration	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Infections and infestations Influenza	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Infections and infestations Lung infection	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Infections and infestations Pneumonia	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Cardiac disorders Prinzmetal angina	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Surgical and medical procedures Sternotomy	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group
Infections and infestations Urosepsis	3.8% 1/26 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	0.00% 0/26 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group	1.9% 1/52 • Number of events 1 • 6 months Adverse Events were monitored for a limited timeframe, ie.up to 6 Months Post-Ablation, by Randomization Group