Blood Coagulation DisordersWatchAFIBNCT02039167
Left Atrial Appendage Occlusion vs. Usual Care in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease
A study testing Left atrial appendage occlusion in people with Blood Coagulation Disorders and Atrial Fibrillation, run by University of Magdeburg at 4 sites in Germany.
Trial summary
The purpose of this study is to evaluate the superiority of left atrial appendage occlusion in comparison to oral anticoagulation with a vitamin K antagonist (INR 2-3) related to the frequency of occurrence of at least one bleeding classified as moderate or major within 24 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Coagulation Disorders, Atrial Fibrillation, Thrombosis of Left Atrial Appendage
- What is being tested?
- Left atrial appendage occlusion
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesGermany
- Study dates
- Jan 2014to 12 Apr 2017
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF), documented by electrocardiography performed at screening or within the prior 6 months
- Indication for oral anticoagulation as assessed by CHA2DS2-VASc-Score (≥ 2)
- Severe to end-stage chronic kidney disease (eGFR < 30 ml/min as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
- 18 to 80 years, inclusive
- Life expectancy of at least 2 years
- Negative pregnancy test for women
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
- Written informed consent
Who cannot join
- AF due to a reversible cause or a singular occurrence of AF
- Conditions other than AF that require anticoagulation
- Transient ischemic attack or stroke within previous 3 months
- A need for Aspirin (at a dose of > 162.5 mg/day) or for both Aspirin and Clopidogrel/other antiplatelet drugs (daily administration) other than for clinical investigation
- Contraindications or allergies to vitamin K antagonists, Aspirin or Clopidogrel
- Previous closure (surgical, interventional) of the left atrial appendage (LAA)
Show all 29Show fewer
- Previous closure of atrial septal defect (ASD) / persistent foramen ovale (PFO)
- Active internal bleeding
- Thrombocytopenia (< 100,000 platelets/mm3)
- History of or planned organ transplantation
- Planned Mitra Clip or transcatheter aortic valve implantation (TAVI) intervention
- Planned cardiac surgery
- History of intracranial, intraocular or retroperitoneal bleeding
- Severe GI-bleeding within the last 3 months
- Hemorrhagic gastro-intestinal diseases (e.g., ulcerative colitis)
- History of or condition associated with increased bleeding risk
- Uncontrolled arterial hypertension
- Heparin-induced thrombocytopenia type II
- Known inherited coagulation disorders
- Severe liver dysfunction (spontaneous INR > 1.5) or liver cirrhosis ≥ CHILD B
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Women who are planning to become pregnant, or who are breastfeeding
- Active infection of any kind
- Transesophageal echocardiography (TEE) Exclusion Criteria
- Intracardiac thrombus or dense spontaneous echo contrast as visualized by TEE (with use of sonovue in suspicious cases)
- Significant mitral valve stenosis
- Any congenital heart disease, including atrial septal defect
- Pericardial effusion during ECHO assessment of > 2 mm
- Cardiac tumor
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Zentralklinik Bad Berka - Klinik für Kardiologie
Bad Berka, 99437
CCB im Markus Krankenhaus Frankfurt
Frankfurt, 60431
Medizinische Hochschule Hannover Zentrum Innere Medizin, Abt. Kardiologie und Angiologie
Hanover, 30625
Otto-von-Guericke University Magdeburg, Faculty of Medicine
Magdeburg, Saxony-Anhalt, 39104
About this study
Official title: WATCH Bleeding Episodes After Left Atrial Appendage Occlusion Versus Usual Care in Patients With Atrial FIBrillatIon and Severe to eNd-stage Chronic Kidney Disease (WatchAFIB in CKD)
The purpose of this study is to evaluate the superiority of left atrial appendage occlusion in comparison to oral anticoagulation with a vitamin K antagonist (INR 2-3) related to the frequency of occurrence of at least one bleeding classified as moderate or major within 24 months.
Read the detailed description
Open, randomized, controlled, multicenter clinical investigation. Transesophageal echocardiography (TEE) for all patients within 14 days of the Enrolment Visit. Patients randomized to oral anticoagulation (OAC) will receive standard of care (SOC) vitamin K antagonist treatment throughout the 24 months clinical investigation period, managed by the primary care physician, with the goal of achieving and maintaining an INR of 2-3 (INR monitoring by the primary care physician every two weeks throughout study period).
Patients randomized to the WATCHMAN device will undergo device implantation within 48 hours of the screening TEE and after confirmation of INR ≤ 1.7 in the catheterization laboratory with a subsequent hospitalization for 24-48 hours.
Concomitant treatment with Aspirin/Clopidogrel (managed by the patient's primary care physician) will be initiated on the day prior to device implantation, and will be continued for 6 months after the procedure, at which time Clopidogrel will be discontinued; administration of Aspirin will be continued indefinitely.
Follow-up visits for all patients will take place on Day 45, and at Month 6, Month 12 and Month 24 (End of Study). Routine safety and efficacy assessments at each visit will be the same for all patients regardless of treatment group.
Follow-up- visits at day 45, months 6, 12 and 24. Patients randomized to the WATCHMAN device will have additional TEE imaging performed at the Day 45 and Month 6 visits.
An independent Data Monitoring Committee will monitor safety. A blinded and independent Endpoint Committee will evaluate end-points throughout the entire study period.
- Conditions
- Blood Coagulation Disorders, Atrial Fibrillation, Thrombosis of Left Atrial Appendage, Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5
- Being tested
- Left atrial appendage occlusion
- Medical subject headings
- Blood Coagulation Disorders, Atrial Fibrillation, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial appendage occlusionDevice
Percutaneous left atrial appendage closure using the WATCHMAN device.
| Study group | Role | What they receive |
|---|---|---|
| Left atrial appendage occlusion | Active comparator | Percutaneous left atrial appendage closure using the WATCHMAN device. Receives: Device: Left atrial appendage occlusion |
| OAC with a vitamin K antagonist | No intervention | Oral anticoagulants (OAC) as Standard of Care (SOC) provided by primary care physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of occurrence of moderate and major bleedings (Type 2 to Type 5 according to the Bleeding Academic Research Consortium (BARC) definitions)
Measured: 24 months
Secondary outcomes (1)
Frequency of at least one occurrence of a combined endpoint of moderate or major bleeding and/or severe cardiovascular adverse events (stroke, cardiac infarction, thrombosis, death)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion21 Mar 2017
- Study completion12 Apr 2017
Why it stopped: The recruitment rate was very poor. The study was stopped by amendment on 2015-08-28.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Ruediger C. Braun-Dullaeus, University of Magdeburg
- Investigators
- Rüdiger C Braun-Dullaeus, Prof, Principal investigator, Otto-von-Guericke University Magdeburg Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039167
- Sponsor's protocol ID
- OVGU-014-Kar
- Acronym
- WatchAFIB
- Status last verified
- Nov 2018
- First submitted
- 15 Jan 2014
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WATCH Bleeding Episodes After Left Atrial Appendage Occlusion Versus Usual Care in Patients With Atrial FIBrillatIon and Severe to eNd-stage Chronic Kidney Disease (WatchAFIB in CKD)
- ClinicalTrials.gov ID
- NCT02039167
- Acronym / sponsor ID
- WatchAFIB / OVGU-014-Kar
- Conditions
- Blood Coagulation Disorders, Atrial Fibrillation, Thrombosis of Left Atrial Appendage, Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment rate was very poor. The study was stopped by amendment on 2015-08-28.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 17 Jan 2014 (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 purpose of this study is to evaluate the superiority of left atrial appendage occlusion in comparison to oral anticoagulation with a vitamin K antagonist (INR 2-3) related to the frequency of occurrence of at least one bleeding classified as moderate or major within 24 months.
Detailed description
Open, randomized, controlled, multicenter clinical investigation. Transesophageal echocardiography (TEE) for all patients within 14 days of the Enrolment Visit. Patients randomized to oral anticoagulation (OAC) will receive standard of care (SOC) vitamin K antagonist treatment throughout the 24 months clinical investigation period, managed by the primary care physician, with the goal of achieving and maintaining an INR of 2-3 (INR monitoring by the primary care physician every two weeks throughout study period).
Patients randomized to the WATCHMAN device will undergo device implantation within 48 hours of the screening TEE and after confirmation of INR ≤ 1.7 in the catheterization laboratory with a subsequent hospitalization for 24-48 hours.
Concomitant treatment with Aspirin/Clopidogrel (managed by the patient's primary care physician) will be initiated on the day prior to device implantation, and will be continued for 6 months after the procedure, at which time Clopidogrel will be discontinued; administration of Aspirin will be continued indefinitely.
Follow-up visits for all patients will take place on Day 45, and at Month 6, Month 12 and Month 24 (End of Study). Routine safety and efficacy assessments at each visit will be the same for all patients regardless of treatment group.
Follow-up- visits at day 45, months 6, 12 and 24. Patients randomized to the WATCHMAN device will have additional TEE imaging performed at the Day 45 and Month 6 visits.
An independent Data Monitoring Committee will monitor safety. A blinded and independent Endpoint Committee will evaluate end-points throughout the entire study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left atrial appendage occlusion | Active comparator | Device: Left atrial appendage occlusionPercutaneous left atrial appendage closure using the WATCHMAN device. |
| OAC with a vitamin K antagonist | No intervention | –Oral anticoagulants (OAC) as Standard of Care (SOC) provided by primary care physician |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF), documented by electrocardiography performed at screening or within the prior 6 months
- Indication for oral anticoagulation as assessed by CHA2DS2-VASc-Score (≥ 2)
- Severe to end-stage chronic kidney disease (eGFR < 30 ml/min as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
- 18 to 80 years, inclusive
- Life expectancy of at least 2 years
Key exclusion criteria (29 listed)
- AF due to a reversible cause or a singular occurrence of AF
- Conditions other than AF that require anticoagulation
- Transient ischemic attack or stroke within previous 3 months
- A need for Aspirin (at a dose of > 162.5 mg/day) or for both Aspirin and Clopidogrel/other antiplatelet drugs (daily administration) other than for clinical investigation
- Contraindications or allergies to vitamin K antagonists, Aspirin or Clopidogrel
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 |
|---|---|---|
| Left atrial appendage occlusionPercutaneous left atrial appendage closure using the WATCHMAN device. | Device | Left atrial appendage occlusion |
Primary outcome
Frequency of occurrence of moderate and major bleedings (Type 2 to Type 5 according to the Bleeding Academic Research Consortium (BARC) definitions)
Time frame: 24 months
1 secondary outcome
Frequency of at least one occurrence of a combined endpoint of moderate or major bleeding and/or severe cardiovascular adverse events (stroke, cardiac infarction, thrombosis, death)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: The recruitment rate was very poor. The study was stopped by amendment on 2015-08-28.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
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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.
Rüdiger C Braun-Dullaeus, Prof principal investigator
Otto-von-Guericke University Magdeburg Faculty of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left atrial appendage occlusion in people with Blood Coagulation Disorders and Atrial Fibrillation, run by University of Magdeburg at 4 sites in Germany.
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 8 inclusion and 29 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: stopped early, as of the sponsor's last update on 21 Nov 2018. 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 Germany. 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 was stopped early (reason given: The recruitment rate was very poor. The study was stopped by amendment on 2015-08-28.). 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?
Frequency of occurrence of moderate and major bleedings (Type 2 to Type 5 according to the Bleeding Academic Research Consortium (BARC) definitions) (time frame: 24 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 21 Nov 2018.