Trial Outcomes & Findings for Persistent Atrial Fibrillation (AF) APAC (Asia Pacific) Observational Study (NCT NCT04244396)
NCT ID: NCT04244396
Last Updated: 2024-04-19
Results Overview
device and/or procedure-related serious adverse events are pre-defined as below with onset within 7-days of any ablation procedure that uses the TactiCath SE catheter (initial or repeat procedure performed ≤180 days of initial procedure) * Atrioesophageal fistula - assessed through 15 months * Cardiac tamponade/perforation - assessed through 15 months * Death * Heart block * Myocardial infarction (MI) * Pericarditis - pleuritic symptoms \>7 days and/or requires hospitalization \>24 hrs for reasons other than observational purposes only * Phrenic nerve injury resulting in diaphragmatic paralysis * Pneumothorax * Pulmonary edema (respiratory insufficiency) * Pulmonary vein stenosis - assessed through 15 months * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vascular access complications (including major bleeding events)
TERMINATED
82 participants
Through 7-days
2024-04-19
Participant Flow
Participant milestones
| Measure |
Drug Refractory, Symptomatic Persistent Atrial Fibrillation
Asian population
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE): TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation.
|
|---|---|
|
Overall Study
STARTED
|
82
|
|
Overall Study
Procedure Completed
|
81
|
|
Overall Study
7-Day Follow-up
|
81
|
|
Overall Study
14-Day Follow-up
|
81
|
|
Overall Study
3-Month Follow-up
|
79
|
|
Overall Study
6-Month Follow-up
|
76
|
|
Overall Study
12-Month Follow-up
|
54
|
|
Overall Study
15-Month Follow-up
|
37
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Drug Refractory, Symptomatic Persistent Atrial Fibrillation
Asian population
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE): TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation.
|
|---|---|
|
Overall Study
Subject did not meet screening inclusion/exclusion criteria
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Study termination
|
37
|
Baseline Characteristics
Persistent Atrial Fibrillation (AF) APAC (Asia Pacific) Observational Study
Baseline characteristics by cohort
| Measure |
Drug Refractory, Symptomatic Persistent Atrial Fibrillation
n=81 Participants
Asian population
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE): TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation.
|
|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 7-daysPopulation: The primary safety endpoint was the rate of pre-specified device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that used the TactiCath SE catheter (initial or repeat procedure performed ≤180 days of initial procedure), with the exception of atrio-esophageal fistula, cardiac tamponade/perforation, and pulmonary vein stenosis which were evaluated through 15-months.
device and/or procedure-related serious adverse events are pre-defined as below with onset within 7-days of any ablation procedure that uses the TactiCath SE catheter (initial or repeat procedure performed ≤180 days of initial procedure) * Atrioesophageal fistula - assessed through 15 months * Cardiac tamponade/perforation - assessed through 15 months * Death * Heart block * Myocardial infarction (MI) * Pericarditis - pleuritic symptoms \>7 days and/or requires hospitalization \>24 hrs for reasons other than observational purposes only * Phrenic nerve injury resulting in diaphragmatic paralysis * Pneumothorax * Pulmonary edema (respiratory insufficiency) * Pulmonary vein stenosis - assessed through 15 months * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vascular access complications (including major bleeding events)
Outcome measures
| Measure |
Drug Refractory, Symptomatic Persistent Atrial Fibrillation
n=81 Participants
Asian population
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE): TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation.
|
|---|---|
|
Rate of Device and/or Procedure-related Serious Adverse Events
|
3 Participants
|
Adverse Events
Drug Refractory, Symptomatic Persistent Atrial Fibrillation
Serious adverse events
| Measure |
Drug Refractory, Symptomatic Persistent Atrial Fibrillation
n=81 participants at risk
Asian population
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE): TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
2.5%
2/81 • Number of events 2 • 15 months
|
|
Blood and lymphatic system disorders
Bleeding/Anemia
|
2.5%
2/81 • Number of events 2 • 15 months
|
|
Blood and lymphatic system disorders
Cerebrovascular Accident/ Stroke
|
1.2%
1/81 • Number of events 1 • 15 months
|
|
Cardiac disorders
Pericardial Effusion
|
3.7%
3/81 • Number of events 3 • 15 months
|
|
Blood and lymphatic system disorders
Volume Overload
|
1.2%
1/81 • Number of events 1 • 15 months
|
|
Cardiac disorders
Chest Pain/Discomfort
|
1.2%
1/81 • Number of events 1 • 15 months
|
|
General disorders
Elective Procedure/Surgery
|
1.2%
1/81 • Number of events 1 • 15 months
|
|
Cardiac disorders
Heart Failure/Pump Failure
|
2.5%
2/81 • Number of events 3 • 15 months
|
|
General disorders
Acute Gout
|
1.2%
1/81 • Number of events 1 • 15 months
|
|
General disorders
Common Bile Duct Stone With Cholangitis
|
1.2%
1/81 • Number of events 1 • 15 months
|
|
General disorders
Finger Fracture
|
1.2%
1/81 • Number of events 1 • 15 months
|
|
General disorders
Unexplained Jaundice And Raised Liver Panel
|
1.2%
1/81 • Number of events 1 • 15 months
|
Other adverse events
| Measure |
Drug Refractory, Symptomatic Persistent Atrial Fibrillation
n=81 participants at risk
Asian population
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE): TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
1.2%
1/81 • Number of events 1 • 15 months
|
|
Blood and lymphatic system disorders
Vascular Bleeding/Local Hematomas/Ecchymosis
|
2.5%
2/81 • Number of events 2 • 15 months
|
|
Infections and infestations
Infection
|
1.2%
1/81 • Number of events 1 • 15 months
|
Additional Information
Emily Jesser Clinical Research Scientist II
Abbott_Medical_Devices
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The data and results from the clinical investigation are the sole property of the Sponsor. The Investigators will not use this clinical investigation-related data without the written consent of the Sponsor for any purpose other than for clinical investigation completion.
- Publication restrictions are in place
Restriction type: OTHER