Trial Outcomes & Findings for Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry (NCT NCT05131308)
NCT ID: NCT05131308
Last Updated: 2024-09-19
Results Overview
Size of leak in mm on TEE after leak closure procedure, immediately at the end of the procedure and at 1 year follow-up
Recruitment status
COMPLETED
Target enrollment
160 participants
Primary outcome timeframe
Immediate postprocedural and 1 year follow-up
Results posted on
2024-09-19
Participant Flow
Enrollment occurred between 2015 and 2021 in the US.
Participant milestones
| Measure |
Detachable Embolization Coils Group
Patients who have an intervention for leak closure with detachable embolization coils
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
Vascular Plugs/Septal Occluders Group
Patients who have an intervention for leak closure with vascular plugs/CSO
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
RF Ablation Group
Patients who have an intervention for leak closure with Radio Frequency Ablation (RFA)
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
36
|
60
|
|
Overall Study
COMPLETED
|
64
|
36
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Detachable Embolization Coils Group
n=64 Participants
Patients who have an intervention for leak closure with detachable embolization coils
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
Vascular Plugs/Septal Occluders Group
n=36 Participants
Patients who have an intervention for leak closure with vascular plugs/CSO
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
RF Ablation Group
n=60 Participants
Patients who have an intervention for leak closure with Radio Frequency Ablation (RFA)
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.7 Years
STANDARD_DEVIATION 9.8 • n=64 Participants
|
71.4 Years
STANDARD_DEVIATION 7.2 • n=36 Participants
|
76 Years
STANDARD_DEVIATION 7.2 • n=60 Participants
|
72.2 Years
STANDARD_DEVIATION 9 • n=160 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=64 Participants
|
0 Participants
n=36 Participants
|
33 Participants
n=60 Participants
|
46 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=64 Participants
|
36 Participants
n=36 Participants
|
27 Participants
n=60 Participants
|
114 Participants
n=160 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Vascular Disease
|
33 Participants
n=64 Participants
|
18 Participants
n=36 Participants
|
15 Participants
n=60 Participants
|
66 Participants
n=160 Participants
|
|
History of CVA/TIA
|
21 Participants
n=64 Participants
|
12 Participants
n=36 Participants
|
24 Participants
n=60 Participants
|
57 Participants
n=160 Participants
|
|
TIA/CVA after primary LAAC before leak closure
|
9 Participants
n=64 Participants
|
3 Participants
n=36 Participants
|
6 Participants
n=60 Participants
|
18 Participants
n=160 Participants
|
|
Previous major bleeding
Intracranial hemorrhage
|
7 Participants
n=64 Participants
|
4 Participants
n=36 Participants
|
6 Participants
n=60 Participants
|
17 Participants
n=160 Participants
|
|
Previous major bleeding
Gastrointestinal
|
11 Participants
n=64 Participants
|
9 Participants
n=36 Participants
|
23 Participants
n=60 Participants
|
43 Participants
n=160 Participants
|
|
Previous major bleeding
No previous major bleeding
|
46 Participants
n=64 Participants
|
23 Participants
n=36 Participants
|
31 Participants
n=60 Participants
|
100 Participants
n=160 Participants
|
|
Leak size prior to closure
Mild (1-2 mm)
|
0 Participants
n=64 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=160 Participants
|
|
Leak size prior to closure
Moderate (3-4 mm)
|
23 Participants
n=64 Participants
|
27 Participants
n=36 Participants
|
16 Participants
n=60 Participants
|
66 Participants
n=160 Participants
|
|
Leak size prior to closure
Severe (>5 mm)
|
41 Participants
n=64 Participants
|
9 Participants
n=36 Participants
|
43 Participants
n=60 Participants
|
93 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Immediate postprocedural and 1 year follow-upSize of leak in mm on TEE after leak closure procedure, immediately at the end of the procedure and at 1 year follow-up
Outcome measures
| Measure |
Detachable Embolization Coils Group
n=64 Participants
Patients who have an intervention for leak closure with detachable embolization coils
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
Vascular Plugs/Septal Occluders Group
n=36 Participants
Patients who have an intervention for leak closure with vascular plugs/CSO
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
RF Ablation Group
n=60 Participants
Patients who have an intervention for leak closure with Radio Frequency Ablation (RFA)
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
|---|---|---|---|
|
Size of PDL After Leak Closure Procedure
Size of PDL at 1 year follow-up · Leak size - > 3 mm
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Size of PDL After Leak Closure Procedure
Size of PDL immediately at the end of the procedure · Leak size - 0 mm
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Size of PDL After Leak Closure Procedure
Size of PDL immediately at the end of the procedure · Leak size - < 1 mm
|
64 Participants
|
36 Participants
|
60 Participants
|
|
Size of PDL After Leak Closure Procedure
Size of PDL immediately at the end of the procedure · Leak size - 2-3 mm
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Size of PDL After Leak Closure Procedure
Size of PDL immediately at the end of the procedure · Leak size - > 3 mm
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Size of PDL After Leak Closure Procedure
Size of PDL at 1 year follow-up · Leak size - 0 mm
|
45 Participants
|
36 Participants
|
31 Participants
|
|
Size of PDL After Leak Closure Procedure
Size of PDL at 1 year follow-up · Leak size - < 1 mm
|
10 Participants
|
0 Participants
|
19 Participants
|
|
Size of PDL After Leak Closure Procedure
Size of PDL at 1 year follow-up · Leak size - 2-3 mm
|
9 Participants
|
0 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From postoperative day 0 to day 7Periprocedural complications occurring from Postoperative days 0 - 7, including: device-related thrombus, pericardial effusion/pericardial tamponade requiring intervention and CVA.
Outcome measures
| Measure |
Detachable Embolization Coils Group
n=64 Participants
Patients who have an intervention for leak closure with detachable embolization coils
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
Vascular Plugs/Septal Occluders Group
n=36 Participants
Patients who have an intervention for leak closure with vascular plugs/CSO
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
RF Ablation Group
n=60 Participants
Patients who have an intervention for leak closure with Radio Frequency Ablation (RFA)
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
|---|---|---|---|
|
Periprocedural Complications Occurring From Postoperative Day 0 - Day 7
CVA
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Periprocedural Complications Occurring From Postoperative Day 0 - Day 7
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Periprocedural Complications Occurring From Postoperative Day 0 - Day 7
Vascular complications
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Periprocedural Complications Occurring From Postoperative Day 0 - Day 7
No complications
|
62 Participants
|
36 Participants
|
60 Participants
|
|
Periprocedural Complications Occurring From Postoperative Day 0 - Day 7
Pericardial effusion/tamponade
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Periprocedural Complications Occurring From Postoperative Day 0 - Day 7
Device-related thrombosis
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 year after procedureSecondary Safety Endpoint: Delayed procedure-related complications at 1 year follow-up including device-related thrombus, pericardial effusion/ pericardial tamponade requiring intervention and CVA.
Outcome measures
| Measure |
Detachable Embolization Coils Group
n=64 Participants
Patients who have an intervention for leak closure with detachable embolization coils
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
Vascular Plugs/Septal Occluders Group
n=36 Participants
Patients who have an intervention for leak closure with vascular plugs/CSO
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
RF Ablation Group
n=60 Participants
Patients who have an intervention for leak closure with Radio Frequency Ablation (RFA)
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA: All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.
|
|---|---|---|---|
|
Delayed Procedure-related Complications at 1 Year Follow-up
Vascular complications
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Delayed Procedure-related Complications at 1 Year Follow-up
Pericardial effusion/tamponade
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Delayed Procedure-related Complications at 1 Year Follow-up
DRT
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Delayed Procedure-related Complications at 1 Year Follow-up
CVA
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Delayed Procedure-related Complications at 1 Year Follow-up
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Delayed Procedure-related Complications at 1 Year Follow-up
No complications
|
64 Participants
|
36 Participants
|
60 Participants
|
Adverse Events
Detachable Embolization Coils Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vascular Plugs/Septal Occluders Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RF Ablation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dhanunjaya Lakkireddy
Kansas City Heart Rhythm Institute
Phone: 913-449-1297
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place