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

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ClinicalTrials.gov Identifier: NCT03193021
Recruitment Status : Completed
First Posted : June 20, 2017
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Cardiva Medical, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Surgical Wound
Interventions Device: Cardiva Mid-Bore VVCS
Other: Manual compression
Enrollment 204
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 100 104
Completed 99 103
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 100 104 204
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 104 participants 204 participants
61.5  (11.6) 63.4  (11.1) 62.5  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 104 participants 204 participants
Female
33
  33.0%
40
  38.5%
73
  35.8%
Male
67
  67.0%
64
  61.5%
131
  64.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 104 participants 204 participants
Hispanic or Latino
3
   3.0%
6
   5.8%
9
   4.4%
Not Hispanic or Latino
97
  97.0%
95
  91.3%
192
  94.1%
Unknown or Not Reported
0
   0.0%
3
   2.9%
3
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 104 participants 204 participants
American Indian or Alaska Native
3
   3.0%
0
   0.0%
3
   1.5%
Asian
2
   2.0%
1
   1.0%
3
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   6.0%
4
   3.8%
10
   4.9%
White
86
  86.0%
93
  89.4%
179
  87.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   3.0%
6
   5.8%
9
   4.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants 104 participants 204 participants
100 104 204
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 100 participants 104 participants 204 participants
29.5  (4.5) 29.7  (5.2) 29.6  (4.9)
1.Primary Outcome
Title Time to Ambulation (TTA)
Hide Description 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.
Time Frame Post-procedure, usually within 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 100 104
Mean (Standard Deviation)
Unit of Measure: hours
2.8  (1.3) 6.1  (1.6)
2.Primary Outcome
Title Major Venous Access Site Closure-related Complications
Hide Description Rate of combined major venous access site closure-related complications attributed directly to the closure method.
Time Frame 30 +/- 7 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Major Venous Access Site Closure-Related Complications, Number of Limbs with Each Event
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 100 104
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Limbs
199 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: major complications
0
(-0.02 to 0.04)
0
(-0.02 to 0.04)
3.Secondary Outcome
Title Minor Venous Access Site Closure-related Complications
Hide Description Rate of combined minor venous access site closure-related complications attributed directly to the closure method.
Time Frame 30 +/- 7 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Combined Venous Access Site Closure-Related Complications, As Reported, Number of Limbs with Each Event
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 100 104
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Limbs
199 209
Measure Type: Number
Unit of Measure: minor complications
2 5
4.Secondary Outcome
Title Time to Discharge Eligibility (TTDE)
Hide Description 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
Time Frame Prior to hospital discharge, usually within 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 100 104
Mean (Standard Deviation)
Unit of Measure: hours
3.1  (1.3) 6.5  (1.9)
5.Secondary Outcome
Title Time to Hemostasis (TTH)
Hide Description 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.
Time Frame Post-procedure, usually within 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 100 104
Mean (Standard Deviation)
Unit of Measure: minutes
6.1  (3.7) 13.7  (6.5)
6.Secondary Outcome
Title Time to Discharge (TTD)
Hide Description 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
Time Frame Prior to hospital discharge, usually within 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 100 104
Mean (Standard Deviation)
Unit of Measure: hours
21.8  (13.4) 21.8  (9.5)
7.Secondary Outcome
Title Time to Closure Eligibility (TTCE)
Hide Description 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)
Time Frame Post-procedure, usually within 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 100 104
Mean (Standard Deviation)
Unit of Measure: minutes
10.5  (6.0) 37.6  (33.2)
8.Secondary Outcome
Title Total Post-Procedure Time (TPPT)
Hide Description Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate
Time Frame Post-procedure, usually within 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 100 104
Mean (Standard Deviation)
Unit of Measure: hours
3.1  (1.3) 6.8  (1.7)
9.Secondary Outcome
Title Procedure Success
Hide Description Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications
Time Frame 30 +/- 7 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 100 104
Measure Type: Count of Participants
Unit of Measure: Participants
Study Subjects
98
  98.0%
103
  99.0%
LTF
2
   2.0%
1
   1.0%
10.Secondary Outcome
Title Device Success
Hide Description Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only)
Time Frame Procedural, usually within 15 minutes of enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of access sites where device insertion was attempted.
Arm/Group Title Cardiva Mid-Bore VVCS
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Femoral Access Sites
363
Measure Type: Number
Unit of Measure: Successful Femoral Access Sites
351
Time Frame 30 days (± 7 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cardiva Mid-Bore VVCS Manual Compression
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Cardiva Mid-Bore VVCS Manual Compression
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)      0/104 (0.00%)    
Hide Serious Adverse Events
Cardiva Mid-Bore VVCS Manual Compression
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/100 (9.00%)      2/104 (1.92%)    
Cardiac disorders     
POST ABLATION -SVT/ AFLUTTER *  1/100 (1.00%)  1 0/104 (0.00%)  0
ACUTE DIASTOLIC HEART FAILURE EXACERBATION *  1/100 (1.00%)  1 0/104 (0.00%)  0
Arterial Perforation - non-access site-related *  1/100 (1.00%)  1 0/104 (0.00%)  0
CHEST PAIN *  1/100 (1.00%)  1 0/104 (0.00%)  0
CHF EXACERBATION *  0/100 (0.00%)  0 1/104 (0.96%)  1
HYPOTENSION *  1/100 (1.00%)  1 0/104 (0.00%)  0
NEW ONSET A-FLUTTER *  1/100 (1.00%)  1 0/104 (0.00%)  0
PERICARDIAL EFFUSION *  1/100 (1.00%)  1 0/104 (0.00%)  0
PERICARDITIS *  0/100 (0.00%)  0 1/104 (0.96%)  1
Infections and infestations     
PNEUMONIA *  1/100 (1.00%)  1 0/104 (0.00%)  0
Renal and urinary disorders     
ACUTE KIDNEY INSUFFICIENCY *  1/100 (1.00%)  1 0/104 (0.00%)  0
Surgical and medical procedures     
FLUID OVERLOAD *  1/100 (1.00%)  1 0/104 (0.00%)  0
POST ABLATION FEVER * [1]  1/100 (1.00%)  1 0/104 (0.00%)  0
Pseudoaneurysm requiring thrombin/fibrin adhesive injection or ultrasound-guided compression *  1/100 (1.00%)  1 0/104 (0.00%)  0
Access site hematoma < 6 cm *  1/100 (1.00%)  1 0/104 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Procedural Complication
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cardiva Mid-Bore VVCS Manual Compression
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/100 (0.00%)      0/104 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Terry Alverson, Director of Regulatory and Clinical
Organization: Cardiva Medical
Phone: 650-207-0563
EMail: Terry_Alverson@cardivamedical.com
Layout table for additonal information
Responsible Party: Cardiva Medical, Inc.
ClinicalTrials.gov Identifier: NCT03193021    
Other Study ID Numbers: PTL 0508
First Submitted: June 16, 2017
First Posted: June 20, 2017
Results First Submitted: January 6, 2020
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020