AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression fo... | NCT03193021

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiva Mid-Bore VVCS	Experimental	Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.	Device: Cardiva Mid-Bore VVCS
Manual Compression	Active Comparator	Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case.	Other: Manual compression

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiva Mid-Bore VVCS	Device	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.	Cardiva Mid-Bore VVCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Ambulation (TTA)	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.	Post-procedure, usually within 6 hours
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.	30 +/- 7 days post-procedure

Secondary Outcomes

Measure	Description	Time Frame
Minor Venous Access Site Closure-related Complications, 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.

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Andrea Natale, MD	Texas Cardiac Arrhythmia Research Foundation	Principal Investigator
Steve Compton, MD	Alaska Heart Institute	Principal Investigator
Mintu Turakhia, MD	Stanford Center for Clinical Research	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alaska Heart & Vascular		Anchorage	Alaska	99508	United States
Mercy General Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31971899	Derived	Natale A, Mohanty S, Liu PY, Mittal S, Al-Ahmad A, De Lurgio DB, Horton R, Spear W, Bailey S, Bunch J, Musat D, O'Neill P, Compton S, Turakhia MP; AMBULATE Trial Investigators. Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial. JACC Clin Electrophysiol. 2020 Jan;6(1):111-124. doi: 10.1016/j.jacep.2019.08.013. Epub 2019 Oct 30.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Dec 22, 2017

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000100 BG001104 BG002204

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00061.5± 11.6 BG00163.4± 11.1 BG00262.5± 11.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00033 BG00140 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0016 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0003 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000100 BG001104 BG002

BMI

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00029.5± 4.5 BG00129.7± 5.2 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Ambulation (TTA)

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.

Posted

Mean

Standard Deviation

hours

Post-procedure, usually within 6 hours

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000100 OG001104

Title

Denominators

Categories

Title	Measurements
	OG0002.8± 1.3 OG0016.1± 1.6

Primary

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.

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

Posted

Number

95% Confidence Interval

major complications

30 +/- 7 days post-procedure

Number of Limbs

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Minor Venous Access Site Closure-related Complications, 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.

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

Posted

Number

minor complications

30 +/- 7 days post-procedure

Number of Limbs

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Time to Discharge Eligibility (TTDE)

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

Posted

Mean

Standard Deviation

hours

Prior to hospital discharge, usually within 24 hours

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Time to Hemostasis (TTH)

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.

Posted

Mean

Standard Deviation

minutes

Post-procedure, usually within 3 hours

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Time to Discharge (TTD)

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

Posted

Mean

Standard Deviation

hours

Prior to hospital discharge, usually within 24 hours

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Time to Closure Eligibility (TTCE)

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)

Posted

Mean

Standard Deviation

minutes

Post-procedure, usually within 6 hours

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Total Post-Procedure Time (TPPT)

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

Posted

Mean

Standard Deviation

hours

Post-procedure, usually within 6 hours

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Procedure Success

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

Posted

Count of Participants

Participants

30 +/- 7 days post-procedure

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Number of Access Sites With Device Success

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

Number of access sites where device insertion was attempted.

Posted

Number

Successful Femoral Access Sites

Procedural, usually within 15 minutes of enrollment

Femoral Access Sites

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	100	9	100	0	100
EG001	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.	0	104	2	104	0	104

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
POST ABLATION -SVT/ AFLUTTER	Cardiac disorders	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
ACUTE KIDNEY INSUFFICIENCY	Renal and urinary disorders	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
ACUTE DIASTOLIC HEART FAILURE EXACERBATION	Cardiac disorders	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
Arterial Perforation - non-access site-related	Cardiac disorders	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
CHEST PAIN	Cardiac disorders	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
CHF EXACERBATION	Cardiac disorders	Non-systematic Assessment		EG0000 events0 affected100 at risk EG0011 events1 affected104 at risk
FLUID OVERLOAD	Surgical and medical procedures	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
HYPOTENSION	Cardiac disorders	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
NEW ONSET A-FLUTTER	Cardiac disorders	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
PERICARDIAL EFFUSION	Cardiac disorders	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
PERICARDITIS	Cardiac disorders	Non-systematic Assessment		EG0000 events0 affected100 at risk EG0011 events1 affected104 at risk
PNEUMONIA	Infections and infestations	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
POST ABLATION FEVER	Surgical and medical procedures	Non-systematic Assessment	Procedural Complication	EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
Pseudoaneurysm requiring thrombin/fibrin adhesive injection or ultrasound-guided compression	Surgical and medical procedures	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk
Access site hematoma < 6 cm	Surgical and medical procedures	Non-systematic Assessment		EG0001 events1 affected100 at risk EG0010 events0 affected104 at risk