Trial Outcomes & Findings for AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID (NCT NCT03193021)

NCT ID: NCT03193021

Last Updated: 2023-03-10

Results Overview

Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 204 participants
• Primary outcome timeframe: Post-procedure, usually within 6 hours
• Results posted on: 2023-03-10

Participant Flow

Participant milestones

Measure	Cardiva Mid-Bore VVCS Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Overall Study STARTED	100	104
Overall Study COMPLETED	99	103
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Cardiva Mid-Bore VVCS Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID

Baseline characteristics by cohort

Measure	Cardiva Mid-Bore VVCS n=100 Participants Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=104 Participants Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.	Total n=204 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 11.6 • n=5 Participants	63.4 years STANDARD_DEVIATION 11.1 • n=7 Participants	62.5 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	40 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	64 Participants n=7 Participants	131 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=5 Participants	95 Participants n=7 Participants	192 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	86 Participants n=5 Participants	93 Participants n=7 Participants	179 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	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	104 participants n=7 Participants	204 participants n=5 Participants
BMI	29.5 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants	29.7 kg/m^2 STANDARD_DEVIATION 5.2 • n=7 Participants	29.6 kg/m^2 STANDARD_DEVIATION 4.9 • n=5 Participants

PRIMARY outcome

Timeframe: Post-procedure, usually within 6 hours

Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site.

Outcome measures

Measure	Cardiva Mid-Bore VVCS n=100 Participants Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=104 Participants Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Time to Ambulation (TTA)	2.8 hours Standard Deviation 1.3	6.1 hours Standard Deviation 1.6

PRIMARY outcome

Timeframe: 30 +/- 7 days post-procedure

Population: Major Venous Access Site Closure-Related Complications, Number of Limbs with Each Event

Rate of combined major venous access site closure-related complications. The method used to determine what would be considered "major" venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.

Outcome measures

Measure	Cardiva Mid-Bore VVCS n=199 Number of Limbs Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=209 Number of Limbs Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event	0 major complications Interval -0.02 to 0.04	0 major complications Interval -0.02 to 0.04

SECONDARY outcome

Timeframe: 30 +/- 7 days post-procedure

Population: Combined Venous Access Site Closure-Related Complications, As Reported, Number of Limbs with Each Event

Rate of combined minor venous access site closure-related complications. The method used to determine what would be considered "minor" venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.

Outcome measures

Measure	Cardiva Mid-Bore VVCS n=199 Number of Limbs Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=209 Number of Limbs Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event	2 minor complications	5 minor complications

SECONDARY outcome

Timeframe: Prior to hospital discharge, usually within 24 hours

Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is eligible for discharge based solely on assessment of the access site

Outcome measures

Measure	Cardiva Mid-Bore VVCS n=100 Participants Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=104 Participants Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Time to Discharge Eligibility (TTDE)	3.1 hours Standard Deviation 1.3	6.5 hours Standard Deviation 1.9

SECONDARY outcome

Timeframe: Post-procedure, usually within 3 hours

Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and first observed and confirmed venous hemostasis, for each access site.

Outcome measures

Measure	Cardiva Mid-Bore VVCS n=100 Participants Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=104 Participants Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Time to Hemostasis (TTH)	6.1 minutes Standard Deviation 3.7	13.7 minutes Standard Deviation 6.5

SECONDARY outcome

Timeframe: Prior to hospital discharge, usually within 24 hours

Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is discharged

Outcome measures

Measure	Cardiva Mid-Bore VVCS n=100 Participants Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=104 Participants Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Time to Discharge (TTD)	21.8 hours Standard Deviation 13.4	21.8 hours Standard Deviation 9.5

SECONDARY outcome

Timeframe: Post-procedure, usually within 6 hours

Elapsed time between removal of the last procedural device for the index procedure and removal of the first Mid-Bore VVCS device (treatment arm) or removal of first sheath (control arm)

Outcome measures

Measure	Cardiva Mid-Bore VVCS n=100 Participants Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=104 Participants Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Time to Closure Eligibility (TTCE)	10.5 minutes Standard Deviation 6.0	37.6 minutes Standard Deviation 33.2

SECONDARY outcome

Timeframe: Post-procedure, usually within 6 hours

Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate

Outcome measures

Measure	Cardiva Mid-Bore VVCS n=100 Participants Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=104 Participants Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Total Post-Procedure Time (TPPT)	3.1 hours Standard Deviation 1.3	6.8 hours Standard Deviation 1.7

SECONDARY outcome

Timeframe: 30 +/- 7 days post-procedure

Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications

Outcome measures

Measure	Cardiva Mid-Bore VVCS n=100 Participants Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=104 Participants Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Number of Participants With Procedure Success Study Subjects	98 Participants	103 Participants
Number of Participants With Procedure Success LTF	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Procedural, usually within 15 minutes of enrollment

Population: Number of access sites where device insertion was attempted.

Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only)

Outcome measures

Measure	Cardiva Mid-Bore VVCS n=363 Femoral Access Sites Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Number of Access Sites With Device Success	351 Successful Femoral Access Sites	—

Adverse Events

Cardiva Mid-Bore VVCS

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Manual Compression

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cardiva Mid-Bore VVCS n=100 participants at risk Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. Cardiva Mid-Bore VVCS: The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.	Manual Compression n=104 participants at risk Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. Manual compression: Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Cardiac disorders POST ABLATION -SVT/ AFLUTTER	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Renal and urinary disorders ACUTE KIDNEY INSUFFICIENCY	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Cardiac disorders ACUTE DIASTOLIC HEART FAILURE EXACERBATION	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Cardiac disorders Arterial Perforation - non-access site-related	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Cardiac disorders CHEST PAIN	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Cardiac disorders CHF EXACERBATION	0.00% 0/100 • 30 days (± 7 days)	0.96% 1/104 • Number of events 1 • 30 days (± 7 days)
Surgical and medical procedures FLUID OVERLOAD	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Cardiac disorders HYPOTENSION	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Cardiac disorders NEW ONSET A-FLUTTER	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Cardiac disorders PERICARDIAL EFFUSION	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Cardiac disorders PERICARDITIS	0.00% 0/100 • 30 days (± 7 days)	0.96% 1/104 • Number of events 1 • 30 days (± 7 days)
Infections and infestations PNEUMONIA	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Surgical and medical procedures POST ABLATION FEVER	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Surgical and medical procedures Pseudoaneurysm requiring thrombin/fibrin adhesive injection or ultrasound-guided compression	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)
Surgical and medical procedures Access site hematoma < 6 cm	1.0% 1/100 • Number of events 1 • 30 days (± 7 days)	0.00% 0/104 • 30 days (± 7 days)

Other adverse events

Adverse event data not reported

Additional Information

Terry Alverson, Director of Regulatory and Clinical

Cardiva Medical

Phone: 650-207-0563

Email: Terry_Alverson@cardivamedical.com

Results disclosure agreements

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

Restriction type: GT60