Atrial FibrillationCAREAVRNCT02626871
Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation
An observational study of Atrial Fibrillation and Stroke, run by University of Turku at 1 site in Finland.
Trial summary
The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and major bleeding events in patients undergoing aortic valve replacement. This retrospective multicenter registry will include 850 patients with aortic valve replacement using bioprosthesis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation, Stroke, Transient Ischemic Attack
- How many people
- 850 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2002to Dec 2015
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comers design of patients undergoing aortic valve bioprosthesis implantation
Who may be able to join
- patients undergoing aortic valve bioprosthesis implantation
Who cannot join
- mechanical heart valves in any position
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and major bleeding events in patients undergoing aortic valve replacement. This retrospective multicenter registry will include 850 patients with aortic valve replacement using bioprosthesis.
- Medical subject headings
- Atrial Fibrillation, Stroke, Ischemic Attack, Transient, Hemorrhage, Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke
Measured: 10 years
Mortality
Measured: 10 years
atrial fibrillation
Measured: 10 years
major bleeding
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJan 2002
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Oulu University Hospital, Kuopio University Hospital
- Responsible party
- Principal investigator, Tuomas Kiviniemi, University of Turku
- Investigators
- Tuomas Kiviniemi, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626871
- Sponsor's protocol ID
- T39/2015
- Acronym
- CAREAVR
- Status last verified
- May 2017
- First submitted
- 8 Dec 2015
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bjorn R, Lehto J, Malmberg M, Anttila V, Airaksinen KEJ, Gunn J, Kiviniemi T. Antithrombotic Medication and Major Complications After Mechanical Aortic Valve Replacement. Am J Cardiol. 2023 Oct 1;204:185-194. doi: 10.1016/j.amjcard.2023.07.097. Epub 2023 Aug 4.
PubMed 37544143Salmi SJ, Nieminen T, Hartikainen J, Biancari F, Lehto J, Nissinen M, Malmberg M, Yannopoulos F, Savolainen J, Airaksinen J, Kiviniemi T. Indications and predictors for pacemaker implantation after isolated aortic valve replacement with bioprostheses: the CAREAVR study. Interact Cardiovasc Thorac Surg. 2020 Sep 1;31(3):398-404. doi: 10.1093/icvts/ivaa119.
PubMed 32747953
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation, Stroke, and Bleeding in Patients Undergoing Aortic Biovalve Implantation
- ClinicalTrials.gov ID
- NCT02626871
- Acronym / sponsor ID
- CAREAVR / T39/2015
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Oulu University Hospital, Kuopio University Hospital
- Study start
- Jan 2002
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Dec 2015 (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.
The primary purpose of the FIN-bioAVR registry is to assess the incidence of AF, strokes and major bleeding events in patients undergoing aortic valve replacement. This retrospective multicenter registry will include 850 patients with aortic valve replacement using bioprosthesis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers design of patients undergoing aortic valve bioprosthesis implantation
Key inclusion criteria (1 listed)
- patients undergoing aortic valve bioprosthesis implantation
Key exclusion criteria (1 listed)
- mechanical heart valves in any position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stroke
Time frame: 10 years
Mortality
Time frame: 10 years
atrial fibrillation
Time frame: 10 years
major bleeding
Time frame: 10 years
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 4 May 2017.
- Derived from this study: PubMed 37544143Bjorn R, Lehto J, Malmberg M, Anttila V, Airaksinen KEJ, Gunn J, Kiviniemi T. Antithrombotic Medication and Major Complications After Mechanical Aortic Valve Replacement. Am J Cardiol. 2023 Oct 1;204:185-194. doi: 10.1016/j.amjcard.2023.07.097. Epub 2023 Aug 4.
- Derived from this study: PubMed 32747953Salmi SJ, Nieminen T, Hartikainen J, Biancari F, Lehto J, Nissinen M, Malmberg M, Yannopoulos F, Savolainen J, Airaksinen J, Kiviniemi T. Indications and predictors for pacemaker implantation after isolated aortic valve replacement with bioprostheses: the CAREAVR study. Interact Cardiovasc Thorac Surg. 2020 Sep 1;31(3):398-404. doi: 10.1093/icvts/ivaa119.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Tuomas Kiviniemi, MD, PhD principal investigator
Turku University Hospital
1 site 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 and Stroke, run by University of Turku at 1 site in Finland.
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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
Stroke (time frame: 10 years). The study lists 4 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 NCT02626871, which also lists 2 linked publications.
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 4 May 2017.