Surgical WoundNCT03193021
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
A study testing Cardiva Mid-Bore VVCS and Manual compression in people with Surgical Wound, run by Cardiva Medical, Inc. at 13 sites in United States.
Trial summary
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Wound
- What is being tested?
- Cardiva Mid-Bore VVCS and Manual compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 13 sitesUnited States
- Study dates
- 20 Sep 2017to 13 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acceptable candidate for an elective, non-emergent catheter-based procedure via the common femoral vein(s) using a 6 to 12 Fr inner diameter introducer sheath, with a minimum of 3 and maximum of 4 femoral venous access sites, and a maximum of 2 access sites/leg
- Anticipated prolonged bedrest (5 hours or more) and / or overnight stay
Who cannot join
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
- Know history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count < 100,000 cells/mm3
- Severe co-existing morbidities with life expectancy less than 12 months
- Femoral arteriotomy or femoral venotomy in < 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days
- Planned femoral venous or arterial access within next 30 days
Show all 12Show fewer
- History of DVT, pulmonary embolism or thrombophlebitis
- Significant anemia or renal insufficiency
- BMI > 45 kg/m2 or < 20 kg/m2
- Unable to routinely walk at least 20 ft. without assistance
- LMWH within 8 hours before or after procedure
- Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath; < 6 Fr or > 12 Fr inner diameter sheath use; obvious bleeding complications or tissue tract estimated to be < 2.5 cm deep
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Alaska Heart & Vascular
Anchorage, Alaska, 99508
Emory St. Joseph's Hospital
Atlanta, Georgia, 30342
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
University of Chicago
Chicago, Illinois, 60637
Intermountain Health Care
Murray, Utah, 84107
Centennial Medical Center
Nashville, Tennessee, 37203
Mount Sinai Hospital
New York, New York, 10029
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
The Valley Hospital
Ridgewood, New Jersey, 07450
Mercy General Hospital
Sacramento, California, 95819
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
Stanford University Hospital
Stanford, California, 94305
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: AMBULATE: Multi-center, RCT for Safety & Efficacy of Cardiva Mid-Bore Venous VCS v. Manual Compression to Close Femoral Venotomies After Catheter-based Interventions Via 6-12F ID Sheaths With Single or Multiple Access Sites Per Limb
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
Read the detailed description
A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing multiple femoral venous access sites and providing reduced times to ambulation compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
Only patients with multiple access sites will be enrolled in order to support the desired indication. Randomization will be stratified to account for patients with varying numbers of access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4 access sites/patient.
- Conditions
- Surgical Wound
- Being tested
- Cardiva Mid-Bore VVCS, Manual compression
- Keywords
- vessel closure, venous access site, femoral venotomy, medium bore, multiple access sites
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiva Mid-Bore VVCSDevice
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 compressionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Manual compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 +/- 7 days post-procedure
Secondary outcomes (8)
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.
Measured: 30 +/- 7 days post-procedure
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
Measured: Prior to hospital discharge, usually within 24 hours
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.
Measured: Post-procedure, usually within 3 hours
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
Measured: Prior to hospital discharge, usually within 24 hours
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)
Measured: Post-procedure, usually within 6 hours
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
Measured: Post-procedure, usually within 6 hours
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
Measured: 30 +/- 7 days post-procedure
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)
Measured: Procedural, usually within 15 minutes of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start20 Sep 2017
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects randomized in 1:1 fashion to either Cardiva Mid-Bore Venous Vascular Closure Device (VVCD) or manual compression for multiple venous access site hemostasis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiva Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Research FoundationSteve Compton, MD, Principal investigator, Alaska Heart InstituteMintu Turakhia, MD, Study director, Stanford Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193021
- Sponsor's protocol ID
- PTL 0508
- Status last verified
- Feb 2023
- First submitted
- 16 Jun 2017
- Last updated
- 10 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31971899
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMBULATE: Multi-center, RCT for Safety & Efficacy of Cardiva Mid-Bore Venous VCS v. Manual Compression to Close Femoral Venotomies After Catheter-based Interventions Via 6-12F ID Sheaths With Single or Multiple Access Sites Per Limb
- ClinicalTrials.gov ID
- NCT03193021
- Acronym / sponsor ID
- PTL 0508
- Conditions
- Surgical Wound
- Keywords
- vessel closure, venous access site, femoral venotomy, medium bore, multiple access sites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Cardiva Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
Detailed description
A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing multiple femoral venous access sites and providing reduced times to ambulation compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
Only patients with multiple access sites will be enrolled in order to support the desired indication. Randomization will be stratified to account for patients with varying numbers of access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4 access sites/patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects randomized in 1:1 fashion to either Cardiva Mid-Bore Venous Vascular Closure Device (VVCD) or manual compression for multiple venous access site hemostasis
| Arm | Type | Receives |
|---|---|---|
| Cardiva Mid-Bore VVCS | Experimental | Device: Cardiva Mid-Bore VVCSCardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. |
| Manual Compression | Active comparator | Other: Manual compressionDirect manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acceptable candidate for an elective, non-emergent catheter-based procedure via the common femoral vein(s) using a 6 to 12 Fr inner diameter introducer sheath, with a minimum of 3 and maximum of 4 femoral venous access sites, and a maximum of 2 access sites/leg
- Anticipated prolonged bedrest (5 hours or more) and / or overnight stay
Key exclusion criteria (12 listed)
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
- Know history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count < 100,000 cells/mm3
- Severe co-existing morbidities with life expectancy less than 12 months
- Femoral arteriotomy or femoral venotomy in < 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiva Mid-Bore VVCSThe 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. | Device | Cardiva Mid-Bore VVCS |
| Manual compressionManual 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. | Other | Manual Compression |
Primary outcome
Time to Ambulation (TTA)
Time frame: 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.
Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Time frame: 30 +/- 7 days post-procedure
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.
8 secondary outcomes
Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Time frame: 30 +/- 7 days post-procedure
Time to Discharge Eligibility (TTDE)
Time frame: Prior to hospital discharge, usually within 24 hours
Time to Hemostasis (TTH)
Time frame: Post-procedure, usually within 3 hours
Time to Discharge (TTD)
Time frame: Prior to hospital discharge, usually within 24 hours
Time to Closure Eligibility (TTCE)
Time frame: Post-procedure, usually within 6 hours
Total Post-Procedure Time (TPPT)
Time frame: Post-procedure, usually within 6 hours
Number of Participants With Procedure Success
Time frame: 30 +/- 7 days post-procedure
Number of Access Sites With Device Success
Time frame: Procedural, usually within 15 minutes of enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31971899Natale 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natale, MD principal investigator
Texas Cardiac Arrhythmia Research Foundation
Steve Compton, MD principal investigator
Alaska Heart Institute
Mintu Turakhia, MD study director
Stanford Center for Clinical Research
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiva Mid-Bore VVCS and Manual compression in people with Surgical Wound, run by Cardiva Medical, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Ambulation (TTA) (time frame: Post-procedure, usually within 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.