Trial Outcomes & Findings for Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture (NCT NCT03040661)

NCT ID: NCT03040661

Last Updated: 2022-01-11

Results Overview

Time Required to Achieve Hemostasis (minutes)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: Time (minutes) from sheath removal till hemostasis achieved
• Results posted on: 2022-01-11

Participant Flow

Participant milestones

Measure	Figure of 8 Suture Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. Ablation for atrial fibrillation.: Ablation for atrial fibrillation.	Manual Hemostasis Group Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. Ablation for atrial fibrillation.: Ablation for atrial fibrillation.
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture

Baseline characteristics by cohort

Measure	Figure of 8 Suture n=35 Participants Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. Ablation for atrial fibrillation.: Ablation for atrial fibrillation.	Manual Hemostasis Group n=35 Participants Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. Ablation for atrial fibrillation.: Ablation for atrial fibrillation.	Total n=70 Participants Total of all reporting groups
Age, Continuous	62.1 years STANDARD_DEVIATION 9.5 • n=5 Participants	62.1 years STANDARD_DEVIATION 9.4 • n=7 Participants	62.1 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	22 Participants n=7 Participants	43 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: Time (minutes) from sheath removal till hemostasis achieved

Time Required to Achieve Hemostasis (minutes)

Outcome measures

Measure	Figure of 8 Suture n=35 Participants Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. Ablation for atrial fibrillation.	Manual Hemostasis Group n=35 Participants Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. Ablation for atrial fibrillation
Time Required to Achieve Hemostasis	0 minutes Standard Deviation 0	15 minutes Standard Deviation 6

PRIMARY outcome

Timeframe: Time (minutes) from completion of procedure till patient leaves room

Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)

Outcome measures

Measure	Figure of 8 Suture n=35 Participants Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. Ablation for atrial fibrillation.	Manual Hemostasis Group n=35 Participants Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. Ablation for atrial fibrillation
Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.	20 minutes Standard Deviation 5	28 minutes Standard Deviation 9

SECONDARY outcome

Timeframe: Assessed after sheath removal till patient discharge

Percent groin complications ( major or minor bleeding, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion) in Figure of 8 suture technique group compared to manual hemostasis group.

Outcome measures

Measure	Figure of 8 Suture n=35 Participants Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. Ablation for atrial fibrillation.	Manual Hemostasis Group n=35 Participants Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. Ablation for atrial fibrillation
Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group	8.6 percent	34.2 percent

Adverse Events

Figure of 8 Suture

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Manual Hemostasis Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Figure of 8 Suture n=35 participants at risk Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. Ablation for atrial fibrillation.	Manual Hemostasis Group n=35 participants at risk Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. Ablation for atrial fibrillation
Surgical and medical procedures Hematoma or minor bleeding at site	5.7% 2/35 • Number of events 35 • In-hospital and 30 days post procedure	5.7% 2/35 • Number of events 35 • In-hospital and 30 days post procedure

Additional Information

Vineet Kumar

Inova Heart and Vascular Institute

Phone: (703) 289-9400

Email: vineet.kumar@inova.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place