Trial Outcomes & Findings for Comparison of Percutaneous Closure to Manual Compression for Hemostasis (NCT NCT04180540)
NCT ID: NCT04180540
Last Updated: 2022-02-07
Results Overview
Starting from sheath pull, time (in minutes) to hemostasis will be compared between study arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
Day 1
Results posted on
2022-02-07
Participant Flow
Participant milestones
| Measure |
Percutaneous Closure
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
|
Overall Study
COMPLETED
|
53
|
54
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Percutaneous Closure to Manual Compression for Hemostasis
Baseline characteristics by cohort
| Measure |
Percutaneous Closure
n=55 Participants
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 Participants
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
62.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Baseline anticoagulation
Aspirin
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Baseline anticoagulation
Clopidogrel/P2Y12 inhibitor
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Baseline anticoagulation
Warfarin
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Baseline anticoagulation
Rivaroxaban
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Baseline anticoagulation
Dabigatran
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Baseline anticoagulation
Apixaban
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Baseline anticoagulation
None
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Medical History
Hypercholesterolemia
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Medical History
Hypertension
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Medical History
Peripheral Vascular Disease
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Medical History
Deep Vein Thrombosis
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medical History
Cerebrovascular Disease
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Medical History
Congestive Heart Failure
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Medical History
Coronary Artery Disease
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Medical History
Prior groin access procedure
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Medical History
Current or ex-smoker
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Medical History
Diabetes
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Medical History
Cancer
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Starting from sheath pull, time (in minutes) to hemostasis will be compared between study arms.
Outcome measures
| Measure |
Percutaneous Closure
n=53 Participants
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 Participants
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Time to Hemostasis
|
4.5 seconds
Interval 1.0 to 11.6
|
10.7 seconds
Interval 9.7 to 14.2
|
SECONDARY outcome
Timeframe: Day 1Population: Of those in the Percutaneous Closure group (n=53), two patients were excluded as they had crossed over to full MC, and 5 others did not undergo secondary randomization due to lack of research staff or logistic challenges. Secondary randomization for six others was deferred at the discretion of the treating provider. Number of those who underwent secondary randomization (n=40).
Time to ambulation (in minutes) following the atrial fibrillation ablation, will be compared between study arms.
Outcome measures
| Measure |
Percutaneous Closure
n=40 Participants
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 Participants
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Time to Ambulation
|
1.33 Hours
Interval 1.23 to 2.5
|
2.25 Hours
Interval 1.91 to 3.2
|
SECONDARY outcome
Timeframe: Day 30Number of complications will be compared between study arms as a composite of all major access site complications and venous thromboembolism.
Outcome measures
| Measure |
Percutaneous Closure
n=53 Participants
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 Participants
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Number of Complications
Complications at Discharge
|
0 Participants
|
1 Participants
|
|
Number of Complications
Complications At follow Up
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 30The Short-form Inguinal Pain Questionnaire is a quality of life metric where respondents report how much pain they have experienced in the past week and how pain has limited their activities. The questionnaire consists of two items, each with a score ranging from 0 to 6. Question 1 asks participants to report the worst pain they have experienced in the past week, where responses range from 0 (no pain) to 6 (pain present, prompt medical advice sought). If participants have experienced pain, Question 2 asks what limitations the pain has caused in performing everyday activities such as sitting down, standing up, or exercising. The total score for question 2 ranges from 0 (none of the listed activities were impacted) to 6 (all listed activities were impacted).
Outcome measures
| Measure |
Percutaneous Closure
n=53 Participants
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 Participants
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Short-form Inguinal Pain Questionnaire Score
Worst pain felt in the groin over the past 7 days
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Short-form Inguinal Pain Questionnaire Score
Extent of limitation of ability to perform different activities by groin pain
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1The length of the procedure to reach hemostasis, in minutes, will be compared between study arms.
Outcome measures
| Measure |
Percutaneous Closure
n=53 Participants
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 Participants
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Procedure Length
Initial Stick to complete hemostasis
|
141.81 minutes
Standard Deviation 35.401
|
146.15 minutes
Standard Deviation 53.805
|
|
Procedure Length
Initial Stick to Out of Lab
|
158.06 minutes
Standard Deviation 35.653
|
156.83 minutes
Standard Deviation 54.346
|
SECONDARY outcome
Timeframe: Day 1 and Day 30Patient satisfaction was assessed with a 6-item instrument where participants responded on a scale from 0 to 5 where 0 = completely satisfied and 5 = completely dissatisfied. The sum of scores can range from 0 to 30 and lower scores indicate greater satisfaction with pain level and appearance of the access site. Measurements were taken at discharge (day 1) and the same instrument was used on follow up (day 30).
Outcome measures
| Measure |
Percutaneous Closure
n=53 Participants
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 Participants
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Patient Satisfaction
Pain in your Groin at Discharge
|
1.13 score on a scale
Standard Deviation 1.455
|
0.72 score on a scale
Standard Deviation 1.14
|
|
Patient Satisfaction
Pain in your Groin at Day 30
|
0.59 score on a scale
Standard Deviation 1.206
|
0.25 score on a scale
Standard Deviation 0.845
|
|
Patient Satisfaction
Tenderness around your groin at Discharge
|
1.21 score on a scale
Standard Deviation 1.405
|
0.65 score on a scale
Standard Deviation 1.067
|
|
Patient Satisfaction
Tenderness around your groin at Day 30
|
0.84 score on a scale
Standard Deviation 1.546
|
0.49 score on a scale
Standard Deviation 1.084
|
|
Patient Satisfaction
Numbness in your groin area at Discharge
|
0.42 score on a scale
Standard Deviation 0.719
|
0.3 score on a scale
Standard Deviation 0.743
|
|
Patient Satisfaction
Numbness in your groin area at Day 30
|
0.29 score on a scale
Standard Deviation 0.764
|
0.08 score on a scale
Standard Deviation 0.392
|
|
Patient Satisfaction
Bruising around your groin area at Discharge
|
0.7 score on a scale
Standard Deviation 1.249
|
0.52 score on a scale
Standard Deviation 1.077
|
|
Patient Satisfaction
Bruising around your groin area at Day 30
|
0.73 score on a scale
Standard Deviation 1.44
|
0.84 score on a scale
Standard Deviation 1.488
|
|
Patient Satisfaction
Problems in your groin where the catheter was inserted at Discharge
|
0.49 score on a scale
Standard Deviation 0.869
|
0.37 score on a scale
Standard Deviation 0.938
|
|
Patient Satisfaction
Problems in your groin where the catheter was inserted at Day 30
|
0.29 score on a scale
Standard Deviation 0.913
|
0.37 score on a scale
Standard Deviation 0.937
|
|
Patient Satisfaction
Appearance of your bruise at Discharge
|
0.64 score on a scale
Standard Deviation 1.128
|
0.41 score on a scale
Standard Deviation 0.962
|
|
Patient Satisfaction
Appearance of your bruise at Day 30
|
0.8 score on a scale
Standard Deviation 1.581
|
0.92 score on a scale
Standard Deviation 1.719
|
|
Patient Satisfaction
Sum of Scores
|
4.58 score on a scale
Standard Deviation 4.99
|
2.96 score on a scale
Standard Deviation 4.813
|
SECONDARY outcome
Timeframe: Day 1Post-procedure narcotic usage for pain medication requirements after hemostasis until discharge from the post-procedure area will be compared between study arms.
Outcome measures
| Measure |
Percutaneous Closure
n=53 Participants
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 Participants
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Pain Medication Needs
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 30Overall costs (in dollars) related to hemostasis and any complications over 30 days will be compared between study arms.
Outcome measures
| Measure |
Percutaneous Closure
n=53 Participants
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 Participants
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Costs
Cost related to Hemostasis
|
882 dollars
Interval 747.0 to
|
4 dollars
Interval 4.0 to 163.0
|
|
Costs
Total cost of procedure
|
882 dollars
Interval 814.5 to
|
42 dollars
Interval 4.0 to 163.0
|
|
Costs
Total cost of care related to procedure
|
57,050.44 dollars
|
56,533.65 dollars
|
SECONDARY outcome
Timeframe: Day 1The number of nursing encounters while in the post-procedure area will be compared between study arms.
Outcome measures
| Measure |
Percutaneous Closure
n=53 Participants
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 Participants
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Number of Nursing Encounters
|
0.06 Number of encounters
Standard Deviation 0.231
|
0.09 Number of encounters
Standard Deviation 0.564
|
Adverse Events
Percutaneous Closure
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Manual Compression
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Percutaneous Closure
n=53 participants at risk
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 participants at risk
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Cardiac disorders
Hematoma at Discharge
|
3.8%
2/53 • Number of events 2 • Event data was collected from baseline during procedure, to follow up 30 days after baseline
|
0.00%
0/54 • Event data was collected from baseline during procedure, to follow up 30 days after baseline
|
|
Cardiac disorders
Hematoma at Follow up
|
0.00%
0/51 • Event data was collected from baseline during procedure, to follow up 30 days after baseline
|
1.9%
1/53 • Number of events 1 • Event data was collected from baseline during procedure, to follow up 30 days after baseline
|
Other adverse events
| Measure |
Percutaneous Closure
n=53 participants at risk
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
|
Manual Compression
n=54 participants at risk
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).
|
|---|---|---|
|
Cardiac disorders
Minor Hematoma at Discharge
|
2.0%
1/51 • Number of events 1 • Event data was collected from baseline during procedure, to follow up 30 days after baseline
|
1.9%
1/54 • Number of events 1 • Event data was collected from baseline during procedure, to follow up 30 days after baseline
|
|
Cardiac disorders
Minor Rebleeding or Ooze at Discharge
|
5.9%
3/51 • Number of events 3 • Event data was collected from baseline during procedure, to follow up 30 days after baseline
|
18.5%
10/54 • Number of events 10 • Event data was collected from baseline during procedure, to follow up 30 days after baseline
|
|
Cardiac disorders
Minor Hematoma at Follow Up
|
0.00%
0/51 • Event data was collected from baseline during procedure, to follow up 30 days after baseline
|
3.8%
2/53 • Number of events 2 • Event data was collected from baseline during procedure, to follow up 30 days after baseline
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place