Heart DiseaseNCT02775565
Initial Experience With the AngioVac Venous Drainage Cannula
An observational study of Heart Disease, run by Angiodynamics, Inc. at 5 sites in United States.
Trial summary
This is a retrospective, record-based study of approximately 100 patients across up to 12 centers within the United States. All patients who have been treated with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit will be considered for study participation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Disease
- What is being tested?
- AngioVac
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2016to May 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients treated at each study site between February 1, 2013 and February 28, 2015 will be included.
Who may be able to join
- Consecutive patients treated at each study site between February 1, 2013 and February 28, 2015 will be included.
Who cannot join
- Patients treated with the AngioVac venous drainage system outside of those dates.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Providence St. Joseph
Burbank, California, 91505
MUSC
Charleston, South Carolina, 29425
Sanford Research
Fargo, North Dakota, 58122
UCLA
Los Angeles, California, 90024
Swedish Health Services
Seattle, Washington, 98122
About this study
Official title: Initial Experience With the AngioVac Venous Drainage Cannula and Cardiopulmonary Bypass Circuit: A Retrospective, Multi-Center Chart Review
This is a retrospective, record-based study of approximately 100 patients across up to 12 centers within the United States. All patients who have been treated with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit will be considered for study participation. Eligible subject must meet all of the inclusion criteria and none of the exclusion criteria to be considered enrolled in the study. The purpose of the study is to describe initial experience with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit.
- Conditions
- Heart Disease
- Being tested
- AngioVac
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioVacDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Detailing early clinical experience with the AngioVac Venous Drainage Cannula
Measured: Experience and success is determined immediately after the procedure is completed. No subject follow up data is collected and retrospective data will be reviewed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775565
- Sponsor's protocol ID
- PV-AV400
- Status last verified
- Dec 2017
- First submitted
- 25 Apr 2016
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Experience With the AngioVac Venous Drainage Cannula and Cardiopulmonary Bypass Circuit: A Retrospective, Multi-Center Chart Review
- ClinicalTrials.gov ID
- NCT02775565
- Acronym / sponsor ID
- PV-AV400
- Conditions
- Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Angiodynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 May 2016 (estimated)
- 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.
This is a retrospective, record-based study of approximately 100 patients across up to 12 centers within the United States. All patients who have been treated with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit will be considered for study participation. Eligible subject must meet all of the inclusion criteria and none of the exclusion criteria to be considered enrolled in the study. The purpose of the study is to describe initial experience with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients treated at each study site between February 1, 2013 and February 28, 2015 will be included.
Key inclusion criteria (1 listed)
- Consecutive patients treated at each study site between February 1, 2013 and February 28, 2015 will be included.
Key exclusion criteria (1 listed)
- Patients treated with the AngioVac venous drainage system outside of those dates.
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 |
|---|---|---|
| AngioVac | Device | – |
Primary outcome
Detailing early clinical experience with the AngioVac Venous Drainage Cannula
Time frame: Experience and success is determined immediately after the procedure is completed. No subject follow up data is collected and retrospective data will be reviewed.
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 8 Dec 2017.
Related trials for Heart Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Recruiting
Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction
Heart Failure
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease, run by Angiodynamics, Inc. at 5 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 1 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Detailing early clinical experience with the AngioVac Venous Drainage Cannula (time frame: Experience and success is determined immediately after the procedure is completed. No subject follow up data is collected and retrospective data will be reviewed.). 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 8 Dec 2017.