Vascular ClosureNCT04203329
AMBULATE Same Day Discharge Registry
An observational study of Vascular Closure, run by Cardiva Medical, Inc. at 15 sites in United States.
Trial summary
A multi-center, prospective, single-arm post market registry, designed to collect both performance and complication outcomes when same day discharge is enabled by the study device, in sealing multiple femoral venous access sites at the completion of ablation procedures for atrial fibrillation with or without another… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Closure
- What is being tested?
- Femoral Venous Vascular Closure
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 15 sitesUnited States
- Study dates
- 30 Jun 2020to Dec 2023
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing ablation procedures for atrial fibrillation with or without another arrhythmia, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.
Who may be able to join
- Pre-Operative Inclusion:
- All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
- ≥18 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent catheter-based paroxysmal atrial fibrillation ablation procedure with or without another arrhythmia via the common femoral vein(s) using a 6 to 12 Fr inner diameter (max 15F OD) introducer sheath
- Is accompanied by a person who will be available to assist the subject for 24 hours post-procedure and/or has access to emergency services;
Show all 18Show fewer
- Is willing/able to stay overnight at the hospital per physician discretion.
- Able and willing to complete two follow-up contacts at 2-4 days and 15 (± 5) days post-procedure.
- Acceptable candidate for emergent vascular surgery, and/or manual compression of the venous access site;
- Intra-Operative Inclusion:
- All criteria apply:
- In the Investigator's opinion, the subject is a candidate for Same Day Discharge per protocol (e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).
- Physician or designee will be on site for discharge evaluation.
- Case completed in time for subject to be reasonably recovered and discharged according to protocol.
- All femoral venous access sites are planned to be closed with the MVP
- Note:
- Initial subject eligibility will be determined based on pre-operative screening.
- Final subject enrollment will be determined at the end the procedure, prior to closure, based on general intra-op exclusion criteria, as well as additional intraoperative criteria. Enrollment is thus determined intra-operatively, at the end of the case and just prior to closure.
Who cannot join
- Pre-Operative Exclusion:
- Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:
- Advanced refusal of blood transfusion, if it should become necessary;
- Active systemic infection, or cutaneous infection or inflammation in the vicinity of the groin;
- Pre-existing immunodeficiency disorder and/or chronic use of high dose systemic steroids;
- Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count < 100,000 cells/mm3;
Show all 125Show fewer
- Severe co-existing morbidities, with a life expectancy of less than 12 months;
- Currently involved in any clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
- Femoral arteriotomy in either limb with any of the following conditions:
- access within < 10 days
- any residual hematoma, significant bruising, or known associated vascular complications
- use of a vascular closure device within the previous 30 days;
- Femoral venotomy in either limb with any of the following conditions:
- access within < 10 days
- any residual hematoma, significant bruising, or known associated vascular complications
- use of a vascular closure device
- Any planned procedure involving femoral arterial or venous access in either limb within the next 30 days;
- Any history of deep vein thrombosis, pulmonary embolism or thrombophlebitis;
- Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or who are lactating;
- Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
- Unable to routinely walk at least 20 feet without assistance;
- Known allergy/adverse reaction to bovine derivatives;
- Administration of low molecular weight heparin (LMWH) within 8 hours before or after the procedure;
- Planned procedures or concomitant condition(s) that may extend ambulation attempts beyond routine ambulation and/or hospital discharge time (e.g., staged procedure, serious co-morbidity, uncontrolled obstructive sleep apnea, congestive heart failure), in the opinion of the Investigator.
- Current diagnosis of persistent or permanent atrial fibrillation.
- General Intra-op Exclusion Criteria:
- Subjects will be excluded from participating in this study if any of the following exclusion criteria occur during the index procedure:
- Any attempt at femoral arterial access during the procedure;
- Any procedural complications that may extend routine recovery, ambulation and discharge times;
- If the physician deems that a different method should be used to achieve hemostasis of the venous access sites, or that the subject should not attempt ambulation according to the protocol requirements;
- All venous access sites must are subject to the following exclusion criteria, assessed immediately prior to enrollment:
- Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, accidental arterial stick with hematoma, "back wall stick", etc.) in any of the study veins;
- A procedural sheath < 6 Fr or > 12 Fr in inner diameter is present at time of closure;
- Venous access site location is noted to be "high", above the inguinal ligament (cephalad to lower half of the femoral head or the inferior epigastric vein origin from the external iliac vein);
- Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula;
- Length of the tissue tract, the distance between the anterior venous wall and skin, is estimated to be less than 2.5 cm.
- Discharge Evaluation Criteria
- Physician or designee must perform discharge evaluation.
- Subject has successfully ambulated without bleeding from access site.
- Subject has been able to void.
- No clinically significant ECG findings.
- Subject is accompanied by a responsible person who will be near them for the next 24 hours. Subjects must meet all Discharge Criteria in order to be eligible for same day discharge at physician discretion.
- Group 2 Persistent A-Fib Pre-Operative Inclusion Criteria All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
- ≥18 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, persistent atrial fibrillation ablation procedure;
- Acceptable candidate planned for same day discharge;
- Able and willing to complete two follow-up contacts at 2-4 days and 15 (± 5) days post-procedure.
- Pre-Operative Exclusion Criteria Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:
- In the index limb(s): Active systemic infection, or cutaneous infection;
- Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count < 100,000 cells/mm3;
- Currently involved in any clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
- Femoral catheterization procedure in any study limb in the previous 30 days;
- Any planned procedure involving femoral arterial or venous access in either limb within the next 30 days;
- History of deep vein thrombosis, pulmonary embolism or thrombophlebitis in the last 12 months;
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or who are lactating;
- Unable to routinely walk at least 20 feet without assistance;
- Known allergy/adverse reaction to bovine derivatives;
- Planned procedures or concomitant condition(s) that may extend ambulation attempts beyond routine ambulation and/or hospital discharge time (e.g., staged procedure, serious co-morbidity, uncontrolled obstructive sleep apnea, congestive heart failure, extreme morbid obesity), in the opinion of the Investigator.
- Intra-Operative Inclusion Criteria
- All criteria apply:
- In the Investigator's opinion, the subject is a candidate for Same Day Discharge per protocol (no procedure related events/complications e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).
- Case completed in time for subject to be reasonably recovered and discharged according to protocol.
- All femoral venous access sites are planned to be closed with the MVP
- Note:
- Initial subject eligibility will be determined based on pre-operative screening.
- Final subject enrollment will be determined at the end the procedure, prior to closure, based on general intra-op exclusion criteria, as well as additional intraoperative criteria. Enrollment is thus determined intra-operatively, at the end of the case and just prior to closure.
- Intra-Operative Exclusion Criteria Subjects will be excluded from participating in this study if any of the following exclusion criteria occur during the index procedure:
- Any attempt at femoral arterial access during the procedure;
- In the index limb(s): infection or inflammation in the vicinity of the groin
- Administration of low molecular weight heparin (LMWH) within 8 hours before or after the procedure;
- All venous access sites must are subject to the following exclusion criteria, assessed immediately prior to enrollment:
- Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, accidental arterial stick with hematoma, "back wall stick", etc.) in any of the study veins;
- A procedural sheath < 6 Fr or > 12 Fr in inner diameter is present at time of closure;
- Venous access site location is noted to be "high", above the inguinal ligament (cephalad to lower half of the femoral head or the inferior epigastric vein origin from the external iliac vein);
- Intra-procedural bleeding around sheath, or forming hematoma at the time of closure;
- Length of the tissue tract, the distance between the anterior venous wall and skin, is estimated to be less than 2.5 cm.
- Discharge Evaluation Criteria
- Physician or designee must perform discharge evaluation on the same day as the procedure.
- Subject has successfully ambulated without bleeding from access site.
- Subject has been able to void.
- No clinically significant ECG findings.
- Subject is accompanied by a responsible person who will be near them for the next 24 hours. Subjects must meet all Discharge Criteria in order to be eligible for same day discharge at physician discretion.
- Group 3 All A-Fib Pre-Operative Inclusion Criteria All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
- ≥18 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, atrial fibrillation ablation procedure;
- Acceptable candidate planned for same day discharge;
- Able and willing to complete two follow-up contacts at 2-4 days and 15 (± 5) days post-procedure.
- Pre-Operative Exclusion Criteria Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:
- In the index limb(s): Active systemic infection, or cutaneous infection;
- Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count < 100,000 cells/mm3;
- Currently involved in any clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
- Femoral catheterization procedure in any study limb in the previous 30 days;
- Any planned procedure involving femoral arterial or venous access in either limb within the next 30 days;
- History of deep vein thrombosis, pulmonary embolism or thrombophlebitis in the last 12 months;
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or who are lactating;
- Unable to routinely walk at least 20 feet without assistance;
- Known allergy/adverse reaction to bovine derivatives;
- Planned procedures or concomitant condition(s) that may extend ambulation attempts beyond routine ambulation and/or hospital discharge time (e.g., staged procedure, serious co-morbidity, uncontrolled obstructive sleep apnea, congestive heart failure, extreme morbid obesity), in the opinion of the Investigator.
- Intra-Operative Inclusion Criteria
- All criteria apply:
- In the Investigator's opinion, the subject is a candidate for Same Day Discharge per protocol (no procedure related events/complications e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).
- Case completed in time for subject to be reasonably recovered and discharged according to protocol.
- All femoral venous access sites are planned to be closed with the MVP
- Note:
- Initial subject eligibility will be determined based on pre-operative screening.
- Final subject enrollment will be determined at the end the procedure, prior to closure, based on general intra-op exclusion criteria, as well as additional intraoperative criteria. Enrollment is thus determined intra-operatively, at the end of the case and just prior to closure.
- Intra-Operative Exclusion Criteria Subjects will be excluded from participating in this study if any of the following exclusion criteria occur during the index procedure:
- Any attempt at femoral arterial access during the procedure;
- In the index limb(s): infection or inflammation in the vicinity of the groin
- Administration of low molecular weight heparin (LMWH) within 8 hours before or after the procedure;
- All venous access sites must are subject to the following exclusion criteria, assessed immediately prior to enrollment:
- Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, accidental arterial stick with hematoma, "back wall stick", etc.) in any of the study veins;
- A procedural sheath < 6 Fr or > 12 Fr in inner diameter is present at time of closure;
- Venous access site location is noted to be "high", above the inguinal ligament (cephalad to lower half of the femoral head or the inferior epigastric vein origin from the external iliac vein);
- Intra-procedural bleeding around sheath, or forming hematoma at the time of closure;
- Length of the tissue tract, the distance between the anterior venous wall and skin, is estimated to be less than 2.5 cm.
- Discharge Evaluation Criteria
- Physician or designee must perform discharge evaluation on the same day as the procedure.
- Subject has successfully ambulated without bleeding from access site.
- Subject has been able to void.
- No clinically significant ECG findings.
- Subject is accompanied by a responsible person who will be near them for the next 24 hours. Subjects must meet all Discharge Criteria in order to be eligible for same day discharge at physician discretion.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Emory St. Joseph's Hospital
Atlanta, Georgia, 30342
Aurora Denver Cardiology Associates, The Medical Center of Aurora
Aurora, Colorado, 80012
Texas Cardiac Arrhythmia Institute
Austin, Texas, 78705
University of Alabama Birmingham
Birmingham, Alabama, 35233
Lahey Clinic
Burlington, Massachusetts, 01805
Cleveland Clinic
Cleveland, Ohio, 44195
Medical City Dallas Hospital
Dallas, Texas, 75230
Medical City Fort Worth
Fort Worth, Texas, 76104
Wake Med Hospital
Raleigh, North Carolina, 27610
Chippenham Hospital
Richmond, Virginia, 23225
Valley Hospital
Ridgewood, New Jersey, 07450
University of Utah Health
Salt Lake City, Utah, 84132
Coastal Cardiology
San Luis Obispo, California, 93401
HonorHealth
Scottsdale, Arizona, 85260
MedStar Washington
Washington D.C., District of Columbia, 20010
About this study
Official title: A Multi-center, Prospective, Single Arm Registry to Evaluate Procedural Outcomes Using the Cardiva VASCADE MVP VVCS Closure Device After Catheter-based Atrial Fibrillation Interventions for Patients Who Are Discharged the Same Day.
A multi-center, prospective, single-arm post market registry, designed to collect both performance and complication outcomes when same day discharge is enabled by the study device, in sealing multiple femoral venous access sites at the completion of ablation procedures for atrial fibrillation with or without another arrhythmia, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.
- Conditions
- Vascular Closure
- Being tested
- Femoral Venous Vascular Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Venous Vascular ClosureDevice
Femoral venous vascular closure following catheter-based cardiac ablation a-fib cases utilizing 6-12 French inner diameter procedural sheaths at time of closure.
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal A-Fib | Not described Receives: Device: Femoral Venous Vascular Closure | |
| Persistent A-Fib | Not described Receives: Device: Femoral Venous Vascular Closure | |
| A-Fib | Not described Receives: Device: Femoral Venous Vascular Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
VASCADE MVP VVCS Procedure Success
Patients do not require next day hospital intervention* due to access site-related complications.
Measured: 1 day
Major Complication Rate
On a per-limb basis, the rate of combined major venous access site closure-related complications attributed directly to the closure method within 15 ± 5 days of discharge (i.e., "device-related" with no other likely attributable cause).
Measured: 15 Days +/- 5 Days
Secondary outcomes (4)
Same Day Procedure Success
Patients do not require next day hospital intervention for any procedure-related reason.
Measured: 1 day
Sustained VASCADE MVP VVCS Procedure Success
Patients do not require hospital intervention within 15 days of discharge due to access site-related complications.
Measured: 15 Days +/- 5 Days
Device Success
The ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the VASCADE MVP VVCS.
Measured: intra-procedural
Minor Complication Rate
On a per-limb basis, the rate of combined minor venous access site closure-related complications attributed directly to the closure method (i.e., "device-related" with no other likely attributable cause.
Measured: 15 Days +/- 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start30 Jun 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ClosureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Cardiva Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203329
- Sponsor's protocol ID
- PTL 0601
- Status last verified
- Aug 2022
- First submitted
- 13 Dec 2019
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Single Arm Registry to Evaluate Procedural Outcomes Using the Cardiva VASCADE MVP VVCS Closure Device After Catheter-based Atrial Fibrillation Interventions for Patients Who Are Discharged the Same Day.
- ClinicalTrials.gov ID
- NCT04203329
- Acronym / sponsor ID
- PTL 0601
- Conditions
- Vascular Closure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Cardiva Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-center, prospective, single-arm post market registry, designed to collect both performance and complication outcomes when same day discharge is enabled by the study device, in sealing multiple femoral venous access sites at the completion of ablation procedures for atrial fibrillation with or without another arrhythmia, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal A-Fib | – | Device: Femoral Venous Vascular Closure |
| Persistent A-Fib | – | Device: Femoral Venous Vascular Closure |
| A-Fib | – | Device: Femoral Venous Vascular Closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing ablation procedures for atrial fibrillation with or without another arrhythmia, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.
Key inclusion criteria (18 listed)
- All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
- ≥18 years of age;
- Capable and willing to give informed consent;
- Acceptable candidate for an elective, non-emergent catheter-based paroxysmal atrial fibrillation ablation procedure with or without another arrhythmia via the common femoral vein(s) using a 6 to 12 Fr inner diameter (max 15F OD) introducer sheath
- Is accompanied by a person who will be available to assist the subject for 24 hours post-procedure and/or has access to emergency services;
Key exclusion criteria (125 listed)
- Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:
- Advanced refusal of blood transfusion, if it should become necessary;
- Active systemic infection, or cutaneous infection or inflammation in the vicinity of the groin;
- Pre-existing immunodeficiency disorder and/or chronic use of high dose systemic steroids;
- Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count < 100,000 cells/mm3;
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 |
|---|---|---|
| Femoral Venous Vascular ClosureFemoral venous vascular closure following catheter-based cardiac ablation a-fib cases utilizing 6-12 French inner diameter procedural sheaths at time of closure. | Device | A-Fib, Paroxysmal A-Fib, Persistent A-Fib |
Primary outcome
VASCADE MVP VVCS Procedure Success
Time frame: 1 day
Patients do not require next day hospital intervention* due to access site-related complications.
Major Complication Rate
Time frame: 15 Days +/- 5 Days
On a per-limb basis, the rate of combined major venous access site closure-related complications attributed directly to the closure method within 15 ± 5 days of discharge (i.e., "device-related" with no other likely attributable cause).
4 secondary outcomes
Same Day Procedure Success
Time frame: 1 day
Sustained VASCADE MVP VVCS Procedure Success
Time frame: 15 Days +/- 5 Days
Device Success
Time frame: intra-procedural
Minor Complication Rate
Time frame: 15 Days +/- 5 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Closure, run by Cardiva Medical, Inc. at 15 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 18 inclusion and 125 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: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Results are not available in the source record.
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?
VASCADE MVP VVCS Procedure Success (time frame: 1 day). 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?
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 Aug 2022.