Atrial FibrillationPhase 4GRAFNCT01461434
Graz Study on the Risk of Atrial Fibrillation
A Phase 4 study testing Medtronic Reveal XT implantable loop recorder in people with Atrial Fibrillation and Hypertension, run by Medical University of Graz at 1 site in Austria.
Trial summary
Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF has developed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Hypertension, Diabetes
- What is being tested?
- Medtronic Reveal XT implantable loop recorder
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2011to Jan 2016
- Phase
- Phase 4
- 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
Who may be able to join
- CHA2DS2-VASc risk score >= 4*
- 18 years or older
Who cannot join
- known history of atrial fibrillation
- implanted rhythm device
- pre-existing indication for oral anticoagulation
- ()CHA2DS2-VASc: C - chronic heart failure (1 point); H - hypertension (1 point); A - age >= 75 years (2 points); D - diabetes (1 point); S - stroke (2 points); V - vascular disease (1 point); A - age >=65 and < 75 years (1 point); Sc - sex category (female) (1 point) ;
Trial locations and contacts
1 site in 1 country.
Austria1 site
LKH/Uniklinikum - Klinische Abteilung für Kardiologie
Graz, 8036
About this study
Official title: Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients
Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease). However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving patients at risk.
Aim of the prospective randomized study is to compare two management strategies for patients at increased risk for AF but without a known history of AF. Patients are seen regularly (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of patients additionally receives a subcutaneous implantation of a loop recorder for continuous rhythm monitoring, while the control group remains on standard follow-up. Observation period is one year (optional extension for 3 years). The time to first diagnosis of AF is compared between groups, blood samples are analyzed for potential biomarkers of AF.
- Being tested
- Medtronic Reveal XT implantable loop recorder
- Keywords
- atrial fibrillation, biomarkers, stroke prevention, implantable loop recorder
- Medical subject headings
- Atrial Fibrillation, Hypertension, Diabetes Mellitus, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Reveal XT implantable loop recorderDevice
subcutaneous implantation
| Study group | Role | What they receive |
|---|---|---|
| loop recorder | Experimental | patients will be implanted with a subcutaneous loop recorder and have regular follow-ups Receives: Device: Medtronic Reveal XT implantable loop recorder |
| regular follow-up | No intervention | patients will receive regular follow-ups with standard ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first diagnosis of atrial fibrillation
Measured: 12 months
Secondary outcomes (5)
Time to change in therapy based on the diagnosis of atrial fibrillation
Measured: Baseline (0 months), 1,2,3,4,5,6,9 and 12 months
Hospitalizations
Measured: 12 months
Change in NTproBNP serum level associated with occurrence of atrial fibrillation
Measured: Baseline (0 months), 1,2,3,4,5,6,9 and 12 months
Death
Measured: 12 months
Stroke
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2015
- Study completionJan 2016 (estimated)
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.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Frank R Heinzel, MD, PhD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461434
- Sponsor's protocol ID
- GRAF-01-SCCT
- Acronym
- GRAF
- Status last verified
- Dec 2015
- First submitted
- 23 Oct 2011
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients
- ClinicalTrials.gov ID
- NCT01461434
- Acronym / sponsor ID
- GRAF / GRAF-01-SCCT
- Keywords
- atrial fibrillation, biomarkers, stroke prevention, implantable loop recorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2011
- Primary completion
- May 2015 (actual)
- Study completion
- Jan 2016 (estimated)
- First posted
- 28 Oct 2011 (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.
Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease). However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving patients at risk.
Aim of the prospective randomized study is to compare two management strategies for patients at increased risk for AF but without a known history of AF. Patients are seen regularly (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of patients additionally receives a subcutaneous implantation of a loop recorder for continuous rhythm monitoring, while the control group remains on standard follow-up. Observation period is one year (optional extension for 3 years). The time to first diagnosis of AF is compared between groups, blood samples are analyzed for potential biomarkers of AF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| loop recorder | Experimental | Device: Medtronic Reveal XT implantable loop recorderpatients will be implanted with a subcutaneous loop recorder and have regular follow-ups |
| regular follow-up | No intervention | –patients will receive regular follow-ups with standard ECG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CHA2DS2-VASc risk score >= 4*
- 18 years or older
Key exclusion criteria (4 listed)
- known history of atrial fibrillation
- implanted rhythm device
- pre-existing indication for oral anticoagulation
- ()CHA2DS2-VASc: C - chronic heart failure (1 point); H - hypertension (1 point); A - age >= 75 years (2 points); D - diabetes (1 point); S - stroke (2 points); V - vascular disease (1 point); A - age >=65 and < 75 years (1 point); Sc - sex category (female) (1 point) ;
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 |
|---|---|---|
| Medtronic Reveal XT implantable loop recordersubcutaneous implantation | Device | loop recorder |
Primary outcome
Time to first diagnosis of atrial fibrillation
Time frame: 12 months
5 secondary outcomes
Time to change in therapy based on the diagnosis of atrial fibrillation
Time frame: Baseline (0 months), 1,2,3,4,5,6,9 and 12 months
Hospitalizations
Time frame: 12 months
Change in NTproBNP serum level associated with occurrence of atrial fibrillation
Time frame: Baseline (0 months), 1,2,3,4,5,6,9 and 12 months
Death
Time frame: 12 months
Stroke
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medtronic Reveal XT implantable loop recorder in people with Atrial Fibrillation and Hypertension, run by Medical University of Graz at 1 site in Austria.
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 4 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 22 Dec 2015. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to first diagnosis of atrial fibrillation (time frame: 12 months). 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 22 Dec 2015.