Trial Outcomes & Findings for ABLATOR Brazil - Ablation Observational Study (Registry) (NCT NCT03041233)
NCT ID: NCT03041233
Last Updated: 2024-07-17
Results Overview
Percent of subjects with a repeat procedure
Recruitment status
COMPLETED
Target enrollment
833 participants
Primary outcome timeframe
up to 6 and 12 months after ablation procedure
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
Enrolled
Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form.
|
|---|---|
|
Overall Study
STARTED
|
833
|
|
Overall Study
Procedure
|
829
|
|
Overall Study
6-month Follow-up
|
803
|
|
Overall Study
12-month Follow-up
|
705
|
|
Overall Study
COMPLETED
|
801
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Enrolled
Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form.
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
16
|
|
Overall Study
Inclusion/Exclusion Criteria Not Met
|
7
|
|
Overall Study
Sponsor Request
|
1
|
|
Overall Study
Duplicate subject
|
1
|
|
Overall Study
Re-ablation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Enrolled
n=833 Participants
Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form.
|
|---|---|
|
Age, Customized
<29 years
|
16 Participants
n=833 Participants
|
|
Age, Customized
30-39 years
|
61 Participants
n=833 Participants
|
|
Age, Customized
40-49 years
|
97 Participants
n=833 Participants
|
|
Age, Customized
50-59 years
|
220 Participants
n=833 Participants
|
|
Age, Customized
60-69 years
|
279 Participants
n=833 Participants
|
|
Age, Customized
70-79 years
|
145 Participants
n=833 Participants
|
|
Age, Customized
>80 years
|
15 Participants
n=833 Participants
|
|
Sex: Female, Male
Female
|
228 Participants
n=833 Participants
|
|
Sex: Female, Male
Male
|
605 Participants
n=833 Participants
|
PRIMARY outcome
Timeframe: up to 6 and 12 months after ablation procedurePopulation: The analysis population is subjects who received atrial fibrillation (AF) ablation for which 6-month and 12-month follow-up data was available for, respectively.
Percent of subjects with a repeat procedure
Outcome measures
| Measure |
Enrolled
n=803 Participants
Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form.
|
|---|---|
|
Unsuccessful Treatment Rate
6 months
|
22 Participants
|
|
Unsuccessful Treatment Rate
12 months
|
21 Participants
|
SECONDARY outcome
Timeframe: up to 6 and 12 months after ablation procedurePopulation: The analysis population is subjects who received AF ablation for which 6-month and 12-month follow-up data was available for, respectively.
Percent of subjects with Cardiovascular SAE.
Outcome measures
| Measure |
Enrolled
n=803 Participants
Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form.
|
|---|---|
|
Cardiovascular Serious Adverse Event (SAE)
6 months
|
2 Participants
|
|
Cardiovascular Serious Adverse Event (SAE)
12 months
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 12 months after ablation procedurePercent of subjects experiencing death within 12 months of ablation procedure
Outcome measures
| Measure |
Enrolled
n=829 Participants
Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form.
|
|---|---|
|
Death in Subjects Who Underwent an Ablation Procedure
Death <30 days post-procedure
|
3 Participants
|
|
Death in Subjects Who Underwent an Ablation Procedure
Death >30 days post-procedure
|
2 Participants
|
Adverse Events
Enrolled
Serious events: 30 serious events
Other events: 1 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Enrolled
n=833 participants at risk
Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Gastrointestinal disorders
Prolonged Hospitalization
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.60%
5/833 • Number of events 5 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.12%
1/833 • Number of events 2 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Vascular disorders
Hematoma
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
General disorders
Drowning
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Catheter Deformation
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.60%
5/833 • Number of events 5 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Hepatobiliary disorders
Death
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Hematuria
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Pulmonary congestion
|
0.48%
4/833 • Number of events 4 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Chest Pain
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Infections and infestations
Skin lesion
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Pericardial Effusion
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Bruise
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
General disorders
Car accident
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Tamponade
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Perioperative infarction
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Sinus dysfunction/asystole after interruption of flutter
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Infections and infestations
Muscle abscess
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Nervous system disorders
Hemorrhagic stroke
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Cardiac disorders
Prolonged hospitalization
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Cardiac disorders
Change in medical strategy
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
|
Cardiac disorders
Suspected bacterial endocarditis
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
Other adverse events
| Measure |
Enrolled
n=833 participants at risk
Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form.
|
|---|---|
|
Injury, poisoning and procedural complications
Hematoma
|
0.12%
1/833 • Number of events 1 • Through 12 months
An adverse event was considered when it was of cardiovascular origin with potential for the following outcomes: * Death; * A serious deterioration of the patient's health, which may result in: life-threatening disease/condition; permanent incapacity of a body structure/function; prolonged hospitalization; medical/surgical intervention to prevent life-threatening illness/injury; malignant tumor; planned hospitalization for a pre-existing condition was not considered a serious adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place