Trial Outcomes & Findings for VAscular Closure for Cardiac Ablation Registry (VACCAR) (NCT NCT03546439)

NCT ID: NCT03546439

Last Updated: 2022-03-11

Results Overview

Time to achieve hemostasis measured in minutes

• Recruitment status: COMPLETED
• Target enrollment: 434 participants
• Primary outcome timeframe: 2 days
• Results posted on: 2022-03-11

Participant Flow

Because this is a registry, there are no randomization procedures. The choice of closure method was chosen by each subject's physicians. The subjects were approached for consent after the procedure.

Participant milestones

Measure	Figure of 8 Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Overall Study STARTED	203	156	75
Overall Study COMPLETED	203	156	75
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	Figure of 8 n=203 Participants Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 Participants Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 Participants Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures	Total n=434 Participants Total of all reporting groups
Age, Continuous	63.34 years STANDARD_DEVIATION 11.0 • n=203 Participants	64.51 years STANDARD_DEVIATION 11.0 • n=156 Participants	66.20 years STANDARD_DEVIATION 11.0 • n=75 Participants	64.0 years STANDARD_DEVIATION 11.0 • n=434 Participants
Sex: Female, Male Female	80 Participants n=203 Participants	58 Participants n=156 Participants	33 Participants n=75 Participants	171 Participants n=434 Participants
Sex: Female, Male Male	123 Participants n=203 Participants	98 Participants n=156 Participants	42 Participants n=75 Participants	263 Participants n=434 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 2 days

Population: There were 434 patients included

Time to achieve hemostasis measured in minutes

Outcome measures

Measure	Figure of 8 n=203 Participants Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 Participants Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 Participants Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Hemostasis	9 minutes Interval 7.0 to 12.1	20 minutes Interval 15.0 to 20.0	7 minutes Interval 4.0 to 10.1

PRIMARY outcome

Timeframe: 2 days

Time to ambulate following hemostasis measured in hours

Outcome measures

Measure	Figure of 8 n=203 Participants Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 Participants Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 Participants Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Ambulation	2.2 Hours Interval 1.3 to 3.5	6.5 Hours Interval 5.1 to 7.8	2.2 Hours Interval 1.4 to 3.5

PRIMARY outcome

Timeframe: 2 days

Number of bleeding and vascular complications

Outcome measures

Measure	Figure of 8 n=203 Participants Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 Participants Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 Participants Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Complications	3 Participants	5 Participants	3 Participants

PRIMARY outcome

Timeframe: 2 days

Length of hospital stay in hours

Outcome measures

Measure	Figure of 8 n=203 Participants Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 Participants Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 Participants Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Hospital Stay	29 hours Interval 26.0 to 30.0	29 hours Interval 28.0 to 30.0	27.5 hours Interval 25.0 to 29.0

POST_HOC outcome

Timeframe: 2 days

Patient's perception of pain is measured using a 5 point Likert scale, range from 1 to 5 with higher scores indicating higher level of pain

Outcome measures

Measure	Figure of 8 n=203 Participants Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 Participants Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 Participants Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Perception of Pain	4 units on a scale Interval 2.0 to 5.0	4 units on a scale Interval 2.0 to 5.0	4 units on a scale Interval 2.0 to 5.0

POST_HOC outcome

Timeframe: 2 days

Patient satisfaction is measured using a 5 point Likert scale with range from 1 to 5 with higher scores indicating greater patient satisfaction

Outcome measures

Measure	Figure of 8 n=203 Participants Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 Participants Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 Participants Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Patient Satisfaction	5 units on a scale Interval 4.0 to 5.0	5 units on a scale Interval 4.0 to 5.0	5 units on a scale Interval 4.0 to 5.0

POST_HOC outcome

Timeframe: 2 days

Patient's need for manual compression is expressed as number of patients as a whole number

Outcome measures

Measure	Figure of 8 n=203 Participants Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 Participants Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 Participants Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Need for Manual Compression	3 Participants	4 Participants	1 Participants

POST_HOC outcome

Timeframe: 2 days

Use of protamine sulfate is expressed as a whole number

Outcome measures

Measure	Figure of 8 n=203 Participants Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 Participants Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 Participants Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Use of Protamine Sulfate	182 Participants	19 Participants	2 Participants

Adverse Events

Figure of 8

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Manual Compression

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Perclose Device

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Figure of 8 n=203 participants at risk Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 participants at risk Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 participants at risk Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Vascular disorders Hematoma	0.00% 0/203 • 7 days	0.64% 1/156 • Number of events 1 • 7 days	0.00% 0/75 • 7 days

Other adverse events

Measure	Figure of 8 n=203 participants at risk Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures	Manual Compression n=156 participants at risk Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures	Perclose Device n=75 participants at risk Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures
Vascular disorders Hematoma	1.5% 3/203 • Number of events 3 • 7 days	2.6% 4/156 • Number of events 4 • 7 days	4.0% 3/75 • Number of events 3 • 7 days

Additional Information

Sanjaya Gupta, MD

Saint Luke's Hospital of Kansas City

Phone: 8169311883

Email: sgupta@saint-lukes.org

Results disclosure agreements

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