Atrial FibrillationNCT04538781
AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry
An observational study of Atrial Fibrillation, run by Cardiva Medical, Inc. at 4 sites in United States.
Trial summary
A multi-center, retrospective, single arm post market registry to evaluate procedural outcomes data using the Cardiva VASCADE MVP Venous Vascular Closure System (VVCS) for the management of the femoral venotomy after catheter-based atrial fibrillation interventions with or without another arrythmia performed via 6-12F… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- VASCADE MVP VVCS
- Type of treatment
- Medical device
- How many people
- 497 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Oct 2020to 8 Feb 2021
- 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: All subjects 1) treated for A-Fib with or without another arrythmia via catheter ablation 2) who received VASCADE MVP with no other vascular closure device and 3) were discharged the same calendar day during the retrospective date range.
Who may be able to join
- ≥18 years of age;
- Underwent catheter-based ablation for atrial fibrillation with or without another arrythmia.
- VASCADE MVP was the only closure device utilized.
- Were discharged the same calendar day as the index procedure.
- Completed a SOC follow-up > 7 days post-procedure.
Who cannot join
- 1. Any additional procedure(s) involving femoral arterial or venous access in either limb within the SOC follow up period as defined by each site (minimum 7 days post-procedure)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lahey Clinic
Burlington, Massachusetts, 01805
Cleveland Clinic
Cleveland, Ohio, 44195
Coastal Cardiology
San Luis Obispo, California, 93401
MedStar Washington
Washington D.C., District of Columbia, 20010
About this study
A multi-center, retrospective, single arm post market registry to evaluate procedural outcomes data using the Cardiva VASCADE MVP Venous Vascular Closure System (VVCS) for the management of the femoral venotomy after catheter-based atrial fibrillation interventions with or without another arrythmia performed via 6-12F procedural sheaths with single or multiple access sites per limb for patients who are discharged the same day.
- Conditions
- Atrial Fibrillation
- Being tested
- VASCADE MVP VVCS
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VASCADE MVP VVCSDevice
The VASCADE MVP Venous Vascular Closure System (VVCS) is indicated for the percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6 - 12F inner diameter (maximum 15F OD) procedural sheaths, with single or multiple access sites in one or both limbs.
| Study group | Role | What they receive |
|---|---|---|
| Same Day Discharge | Patients undergoing a-fib ablation procedures who were closed with VASCADE MVP and were discharged the same day. Receives: Device: VASCADE MVP VVCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from next day access site closure-related complications requiring hospital intervention
Primary Performance Outcome
Measured: 1 day
rate of major venous access site closure-related complications
Major Complication rate
Measured: ≥7 days
Secondary outcomes (3)
Freedom from next day procedure-related complications requiring hospital intervention
Secondary Performance Outcome
Measured: 1 day
Freedom from access site closure-related complications requiring hospital intervention through standard of care follow up contact
Secondary Performance Outcome
Measured: ≥7 days
minor venous access site closure-related complications
Minor Complication rate
Measured: ≥7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start9 Oct 2020
- Primary completion11 Jan 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Retrospective
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiva Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538781
- Sponsor's protocol ID
- PTL 0617
- Status last verified
- Dec 2020
- First submitted
- 31 Aug 2020
- Last updated
- 1 Mar 2021
- 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 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry
- ClinicalTrials.gov ID
- NCT04538781
- Acronym / sponsor ID
- PTL 0617
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Cardiva Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 4 Sep 2020 (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, retrospective, single arm post market registry to evaluate procedural outcomes data using the Cardiva VASCADE MVP Venous Vascular Closure System (VVCS) for the management of the femoral venotomy after catheter-based atrial fibrillation interventions with or without another arrythmia performed via 6-12F procedural sheaths with single or multiple access sites per limb for patients who are discharged the same day.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Same Day Discharge | – | Device: VASCADE MVP VVCSPatients undergoing a-fib ablation procedures who were closed with VASCADE MVP and were discharged the same day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects 1) treated for A-Fib with or without another arrythmia via catheter ablation 2) who received VASCADE MVP with no other vascular closure device and 3) were discharged the same calendar day during the retrospective date range.
Key inclusion criteria (5 listed)
- ≥18 years of age;
- Underwent catheter-based ablation for atrial fibrillation with or without another arrythmia.
- VASCADE MVP was the only closure device utilized.
- Were discharged the same calendar day as the index procedure.
- Completed a SOC follow-up > 7 days post-procedure.
Key exclusion criteria (1 listed)
- 1. Any additional procedure(s) involving femoral arterial or venous access in either limb within the SOC follow up period as defined by each site (minimum 7 days post-procedure)
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 |
|---|---|---|
| VASCADE MVP VVCSThe VASCADE MVP Venous Vascular Closure System (VVCS) is indicated for the percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6 - 12F inner diameter (maximum 15F OD) procedural sheaths, with single or multiple access sites in one or both limbs. | Device | Same Day Discharge |
Primary outcome
Freedom from next day access site closure-related complications requiring hospital intervention
Time frame: 1 day
Primary Performance Outcome
rate of major venous access site closure-related complications
Time frame: ≥7 days
Major Complication rate
3 secondary outcomes
Freedom from next day procedure-related complications requiring hospital intervention
Time frame: 1 day
Freedom from access site closure-related complications requiring hospital intervention through standard of care follow up contact
Time frame: ≥7 days
minor venous access site closure-related complications
Time frame: ≥7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Cardiva Medical, Inc. at 4 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 5 inclusion and 1 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Freedom from next day access site closure-related complications requiring hospital intervention (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 1 Mar 2021.