Trial Outcomes & Findings for ABLATOR Ablation Observational Registry (NCT NCT02344173)

Last Updated: 2019-06-05

Results Overview

Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure.

Recruitment status

COMPLETED

Target enrollment

2035 participants

Primary outcome timeframe

12 months post procedure

Results posted on

2019-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	All Enrolled Subjects Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent.
Enrollment STARTED	2035
Enrollment COMPLETED	2035
Enrollment NOT COMPLETED	0
Procedure STARTED	2035
Procedure COMPLETED	2028
Procedure NOT COMPLETED	7
12-month Visit STARTED	2028
12-month Visit COMPLETED	1932
12-month Visit NOT COMPLETED	96

Reasons for withdrawal

Reasons for withdrawal
Measure	All Enrolled Subjects Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent.
Procedure Ablation Procedure Not Performed	7
12-month Visit Death	8
12-month Visit Withdrawal by Subject	30
12-month Visit Lost to Follow-up	58

Baseline Characteristics

Data for 1 patient is missing.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=2035 Participants Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent.
Age, Continuous	61.1 years STANDARD_DEVIATION 10.4 • n=2034 Participants • Data for 1 patient is missing.
Sex: Female, Male Female	639 Participants n=2032 Participants • Data is missing for 3 patients.
Sex: Female, Male Male	1393 Participants n=2032 Participants • Data is missing for 3 patients.
Indication for procedure Paroxysmal AF	1151 Participants n=2028 Participants • Data is missing for 7 patients.
Indication for procedure Persistent AF	746 Participants n=2028 Participants • Data is missing for 7 patients.
Indication for procedure Permanent AF	131 Participants n=2028 Participants • Data is missing for 7 patients.
Had Prior AF Ablation Yes	1581 Participants n=2028 Participants • Data missing for 7 patients.
Had Prior AF Ablation No	447 Participants n=2028 Participants • Data missing for 7 patients.
Percentage of Left Ventricular Ejection Fraction	58.7 % STANDARD_DEVIATION 9.4 • n=1178 Participants • Measure Analysis Population Description: Data not collected from all patients.
Left Atrial Diameter	42.5 mm STANDARD_DEVIATION 11.2 • n=1251 Participants • Data not collected from all patients.
Left Atrial Volume	76 mL STANDARD_DEVIATION 39.7 • n=476 Participants • Data not collected from all patients.

PRIMARY outcome

Timeframe: 12 months post procedure

Population: Subjects that completed 12-month visit

Outcome measures

Outcome measures
Measure	Per-Protocol n=1932 Participants Patients that were enrolled, received RF ablation therapy, and completed 12-month follow-up
Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period.	1297 Participants

PRIMARY outcome

Timeframe: 12 months post procedure

Population: Treated Subjects

Outcome measures

Outcome measures
Measure	Per-Protocol n=2028 Participants Patients that were enrolled, received RF ablation therapy, and completed 12-month follow-up
Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period.	1297 Participants

PRIMARY outcome

Timeframe: 12 months post procedure

Population: Enrolled subjects

Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin ("Cardiovascular Serious Adverse Event") with the potential of leading to: * Death * A serious deterioration in the health of the subject * Fetal distress, fetal death or a congenital abnormality or birth defect A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required.

Outcome measures

Outcome measures
Measure	Per-Protocol n=2035 Participants Patients that were enrolled, received RF ablation therapy, and completed 12-month follow-up
Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs.	43 Participants

Adverse Events

All Enrolled Subjects

Serious events: 356 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	All Enrolled Subjects n=2035 participants at risk Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent.
Cardiac disorders Abnormal ECG	0.25% 5/2035 • Number of events 5 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Angina (Chest Pain)	0.54% 11/2035 • Number of events 11 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Arrhythmia	12.2% 249/2035 • Number of events 304 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Gastrointestinal disorders Atrio-esophageal fistula	0.05% 1/2035 • Number of events 1 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Vascular disorders AV Fistula	0.05% 1/2035 • Number of events 1 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Complete Heart Block	0.15% 3/2035 • Number of events 3 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
General disorders Death	0.10% 2/2035 • Number of events 2 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Exacerbation of Pre-Existing Atrial Fibrillation	1.0% 21/2035 • Number of events 26 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Heart Block	0.05% 1/2035 • Number of events 1 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Heart Failure	0.25% 5/2035 • Number of events 5 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Vascular disorders Hypotension	0.05% 1/2035 • Number of events 1 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Myocardial Infarction	0.10% 2/2035 • Number of events 2 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Vascular disorders Obstruction/Perforation/Damage of The Vascular System	0.10% 2/2035 • Number of events 2 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
General disorders Other	1.5% 31/2035 • Number of events 36 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Palpitation	0.34% 7/2035 • Number of events 7 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Pericardial Effusion Without Tamponade	0.29% 6/2035 • Number of events 7 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Pericardial Effusion/Cardiac Tamponade	0.69% 14/2035 • Number of events 14 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Pericarditis	0.20% 4/2035 • Number of events 4 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Pulmonary Edema	0.05% 1/2035 • Number of events 1 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Vascular disorders Pulmonary Vein Stenosis	0.05% 1/2035 • Number of events 1 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Vascular disorders Pulmonary Vein Thrombus	0.05% 1/2035 • Number of events 1 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Sinus Node Dysfunction	0.39% 8/2035 • Number of events 8 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Nervous system disorders Stroke/cerebral vascular accidents	0.25% 5/2035 • Number of events 5 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Vascular disorders Vascular Access/Bleeding Complications	0.44% 9/2035 • Number of events 10 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Cardiac disorders Ventricular Arrhythmia Requiring Defibrillation	0.10% 2/2035 • Number of events 2 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Vascular disorders Vessel Wall/Valvular Damage or Insufficiency	0.20% 4/2035 • Number of events 4 • SAE/SADE information was collected from the time of enrollment through 12 months (+/- 30 day visit window) Only SAEs deemed to be of a cardiovascular origin were reportable in ABLATOR. A planned hospitalization for a pre-existing condition was not considered an SAE. Other \[Not Including Serious\] Adverse Events were not monitored/assessed.

Other adverse events

Adverse event data not reported

Additional Information

Principal Clinical Research Scientist

Abbott

Phone: 6517564067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place