Trial Outcomes & Findings for Irrigated Ablation System Evaluation for Atrial Fibrillation (AF) (NCT NCT01056328)
NCT ID: NCT01056328
Last Updated: 2019-02-26
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
324 participants
Primary outcome timeframe
20 minutes after initial isolation
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
SJM Cardiac Ablation System
SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
|
FDA Approved Open Irriagated RF Ablation System
FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
160
|
|
Overall Study
COMPLETED
|
147
|
144
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
Baseline characteristics by cohort
| Measure |
SJM Cardiac Ablation System
n=164 Participants
SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
|
FDA Approved Open Irriagated RF Ablation System
n=160 Participants
FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
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
|
96 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
68 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
149 participants
n=5 Participants
|
149 participants
n=7 Participants
|
298 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 minutes after initial isolationOutcome measures
| Measure |
SJM Cardiac Ablation System
n=164 Participants
SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
|
FDA Approved Open Irriagated RF Ablation System
n=160 Participants
FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
|
|---|---|---|
|
Confirmation of Entrance Block in the Pulmonary Veins
|
159 participants
|
157 participants
|
PRIMARY outcome
Timeframe: 7 daysAtrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.
Outcome measures
| Measure |
SJM Cardiac Ablation System
n=134 Participants
SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
|
FDA Approved Open Irriagated RF Ablation System
n=131 Participants
FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
|
|---|---|---|
|
Incidence of Adverse Events Included in the Pre-specified Composite
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
SJM Cardiac Ablation System
n=134 Participants
SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
|
FDA Approved Open Irriagated RF Ablation System
n=131 Participants
FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
|
|---|---|---|
|
Incidence of Adverse Events Included in the Pre-specified Composite.
|
12 participants
|
13 participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
SJM Cardiac Ablation System
n=147 Participants
SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
|
FDA Approved Open Irriagated RF Ablation System
n=131 Participants
FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
|
|---|---|---|
|
Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
|
116 participants
|
119 participants
|
SECONDARY outcome
Timeframe: 12 monthsEarly onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)
Outcome measures
| Measure |
SJM Cardiac Ablation System
n=158 Participants
SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
|
FDA Approved Open Irriagated RF Ablation System
n=157 Participants
FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
|
|---|---|---|
|
Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs
|
40 participants
|
26 participants
|
Adverse Events
SJM Cardiac Ablation System
Serious events: 26 serious events
Other events: 14 other events
Deaths: 0 deaths
FDA Approved Open Irrigated RF Ablation System
Serious events: 16 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SJM Cardiac Ablation System
n=164 participants at risk
SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
|
FDA Approved Open Irrigated RF Ablation System
n=160 participants at risk
FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
|
|---|---|---|
|
Cardiac disorders
Pulmonary vein stenosis
|
3.0%
5/164 • Number of events 5
|
4.4%
7/160 • Number of events 7
|
|
Cardiac disorders
Cardiac perforation
|
0.61%
1/164 • Number of events 1
|
0.62%
1/160 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest and back pain
|
0.61%
1/164 • Number of events 1
|
0.00%
0/160
|
|
Cardiac disorders
Heart failure
|
0.61%
1/164 • Number of events 1
|
0.00%
0/160
|
|
Cardiac disorders
Hypotension
|
1.2%
2/164 • Number of events 2
|
0.00%
0/160
|
|
Vascular disorders
Local hematoma
|
0.61%
1/164 • Number of events 1
|
0.00%
0/160
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
2/164 • Number of events 2
|
0.00%
0/160
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.61%
1/164 • Number of events 1
|
0.00%
0/160
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.2%
2/164 • Number of events 2
|
0.00%
0/160
|
|
Cardiac disorders
Arrhythmia
|
1.2%
2/164 • Number of events 2
|
0.00%
0/160
|
|
Cardiac disorders
Coronary artery spasm
|
0.00%
0/164
|
1.2%
2/160 • Number of events 2
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/164
|
0.62%
1/160 • Number of events 1
|
|
General disorders
Other
|
4.9%
8/164 • Number of events 8
|
3.8%
6/160 • Number of events 6
|
Other adverse events
| Measure |
SJM Cardiac Ablation System
n=164 participants at risk
SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
|
FDA Approved Open Irrigated RF Ablation System
n=160 participants at risk
FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Chest and back pain
|
0.61%
1/164 • Number of events 1
|
0.62%
1/160 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
0.61%
1/164 • Number of events 1
|
0.62%
1/160 • Number of events 1
|
|
Infections and infestations
Infection
|
1.2%
2/164 • Number of events 2
|
0.00%
0/160
|
|
Vascular disorders
Local hematoma
|
1.8%
3/164 • Number of events 3
|
1.2%
2/160 • Number of events 2
|
|
Cardiac disorders
Pericarditis
|
0.61%
1/164 • Number of events 1
|
0.00%
0/160
|
|
Vascular disorders
Pseudoaneurysm
|
0.00%
0/164
|
0.62%
1/160 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin burn
|
0.00%
0/164
|
0.62%
1/160 • Number of events 1
|
|
General disorders
Other
|
3.7%
6/164 • Number of events 6
|
2.5%
4/160 • Number of events 4
|
Additional Information
Nicole Glowacki, Clinical Project Manager
St. Jude Medical
Phone: 651-756-3432
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER