Atrial FibrillationNCT02787525
Comparison of Outcomes After Left Atrial Appendage Closure or Oral Anticoagulation in Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
The aim of the study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients with non-valvular atrial fibrillation treated with either oral anticoagulation or who had undergone LAA-closure (left atrial closure). 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?
- Questionnaire
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2016
- 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: * Group A ("OAC"): Patients having been hospitalized between 2009 and 2014 in the Bern university hospital and discharged with either OAC or NOAC. * Group B (LAA-closure): Patients who underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich
Who may be able to join
- Age >/= 18 years
- Written informed consent to participate in the study
- Paroxysmal, persistent, or permanent non-valvular atrial fibrillation.
- Group A ("OAC"): Having been hospitalized between 2009 and 2014 in the Bern university hospital and discharged with either OAC or NOAC.
- Group B (LAA-closure): Underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich
Who cannot join
- No full data on matching criteria (which are described below under "study design")
- Only for group A: Not matched patients having been dropped out after the propensity score matching
About this study
Official title: Comparison of Clinical Outcomes After Left Atrial Appendage Closure or Oral Anticoagulation in Patients With Atrial Fibrillation: A Retrospective Propensity Matched Study
The aim of the study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients with non-valvular atrial fibrillation treated with either oral anticoagulation or who had undergone LAA-closure (left atrial closure).
A questionnaire is sent to the patients and if there is some information missing or unclear, the investigators will contact the patient or the treating physicians to get the missing/unclear information.
Read more
The study population consists of 500 patients with non-valvular atrial fibrillation (AF) who underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital und Zurich University hospital) and a similar group of 500 patients with non-valvular AF treated with oral anticoagulation (OAC).
In order to compare the two groups and reducing the bias due to confounding variables, a propensity score matching will be performed.
Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy and safety in comparison to lifelong oral anticoagulation in patients with non-valvular atrial fibrillation.
Read the detailed description
Non-valvular atrial fibrillation is the most common arrhythmia with an estimated prevalence of 1-2% in the general population, increasing with age. Patients with AF are at increased risk of thromboembolism, in particular ischemic stroke.
LAAC seems at the actual knowledge to be a valid alternative to OAC. The objective of this study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients receiving Amplatzer devices vs. propensity score matched patients treated with OAC.
A questionnaire is sent to the patients asking about thrombo-embolic events, stroke, death, any bleeding but also on their current medication, comorbidities (i.e. arterial hypertension, diabetes mellitus, renal impairment and liver disease), any hospitalizations and their quality of life. If there is some information missing or unclear, the investigators will contact the patient or the treating physicians to get the missing information.
The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of 500 patients with non-valvular AF who underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital und Zurich University hospital) and a propensity score matched patients group of 500 patients with non-valvular AF treated with OAC.
Covariates for matching will be age, gender, renal function, coronary artery disease and its status of revascularization, left-ventricular function, HAS-BLED and CHA2DS2-VASc-Score.
Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy and safety in comparison to lifelong oral anticoagulation in patients with non-valvular atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Questionnaire
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A clinical sweep follow up will be performed in all patients of both groups and results will be analyzed. It will be in form of a standardized questionnaire and if necessary telephone interviews asking about thrombo-embolic events, stroke, death, any bleeding but also on their current medication, comorbidities (i.e. arterial hypertension, diabetes mellitus, renal impairment and liver disease), any hospitalizations and their quality of life. For all events, the source documents will be gathered from general physicians, cardiologists, hospitals or registry offices.
The questionnaire will be sent by mail to the patients. If information is missing or unclear, patients and if necessary their treating physician will be contacted by phone.
| Study group | Role | What they receive |
|---|---|---|
| A: patients on anticoagulation | Questionnaire to patients with non-valvular atrial fibrillation on OAC or NOAC Receives: Other: Questionnaire | |
| B: patients treated by LAA-Closure | Questionnaire to patient with non-valvular atrial fibrillation who underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intermedium-term clinical outcomes, including thromboembolic events and bleeding complications in patients receiving Amplatzer devices vs. propensity score matched patients treated with OAC.
Measured: Clinical sweep follow up, the mean follow-up will be approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steffen Gloeckler, PD Dr. med, Principal investigator, University hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787525
- Sponsor's protocol ID
- 2016-00630
- Other IDs
- 2016
- Status last verified
- Jan 2017
- First submitted
- 25 May 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
PubMed 25399274Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.
PubMed 23583249Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbacker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzaghi M, Vermeersch P, Stock F, Stolcova M, Costa M, Ibrahim R, Schillinger W, Meier B, Park JW. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2016 Feb;11(10):1170-9. doi: 10.4244/EIJY15M01_06.
PubMed 25604089Nietlispach F, Gloekler S, Krause R, Shakir S, Schmid M, Khattab AA, Wenaweser P, Windecker S, Meier B. Amplatzer left atrial appendage occlusion: single center 10-year experience. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):283-9. doi: 10.1002/ccd.24872. Epub 2013 Mar 22.
PubMed 23412815
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes After Left Atrial Appendage Closure or Oral Anticoagulation in Patients With Atrial Fibrillation: A Retrospective Propensity Matched Study
- ClinicalTrials.gov ID
- NCT02787525
- Acronym / sponsor ID
- 2016-00630
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Jun 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.
The aim of the study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients with non-valvular atrial fibrillation treated with either oral anticoagulation or who had undergone LAA-closure (left atrial closure).
A questionnaire is sent to the patients and if there is some information missing or unclear, the investigators will contact the patient or the treating physicians to get the missing/unclear information.
The study population consists of 500 patients with non-valvular atrial fibrillation (AF) who underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital und Zurich University hospital) and a similar group of 500 patients with non-valvular AF treated with oral anticoagulation (OAC).
In order to compare the two groups and reducing the bias due to confounding variables, a propensity score matching will be performed.
Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy and safety in comparison to lifelong oral anticoagulation in patients with non-valvular atrial fibrillation.
Detailed description
Non-valvular atrial fibrillation is the most common arrhythmia with an estimated prevalence of 1-2% in the general population, increasing with age. Patients with AF are at increased risk of thromboembolism, in particular ischemic stroke.
LAAC seems at the actual knowledge to be a valid alternative to OAC. The objective of this study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients receiving Amplatzer devices vs. propensity score matched patients treated with OAC.
A questionnaire is sent to the patients asking about thrombo-embolic events, stroke, death, any bleeding but also on their current medication, comorbidities (i.e. arterial hypertension, diabetes mellitus, renal impairment and liver disease), any hospitalizations and their quality of life. If there is some information missing or unclear, the investigators will contact the patient or the treating physicians to get the missing information.
The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of 500 patients with non-valvular AF who underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital und Zurich University hospital) and a propensity score matched patients group of 500 patients with non-valvular AF treated with OAC.
Covariates for matching will be age, gender, renal function, coronary artery disease and its status of revascularization, left-ventricular function, HAS-BLED and CHA2DS2-VASc-Score.
Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy and safety in comparison to lifelong oral anticoagulation in patients with non-valvular atrial fibrillation.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: patients on anticoagulation | – | Other: QuestionnaireQuestionnaire to patients with non-valvular atrial fibrillation on OAC or NOAC |
| B: patients treated by LAA-Closure | – | Other: QuestionnaireQuestionnaire to patient with non-valvular atrial fibrillation who underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Group A ("OAC"): Patients having been hospitalized between 2009 and 2014 in the Bern university hospital and discharged with either OAC or NOAC. * Group B (LAA-closure): Patients who underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich
Key inclusion criteria (5 listed)
- Age >/= 18 years
- Written informed consent to participate in the study
- Paroxysmal, persistent, or permanent non-valvular atrial fibrillation.
- Group A ("OAC"): Having been hospitalized between 2009 and 2014 in the Bern university hospital and discharged with either OAC or NOAC.
- Group B (LAA-closure): Underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich
Key exclusion criteria (2 listed)
- No full data on matching criteria (which are described below under "study design")
- Only for group A: Not matched patients having been dropped out after the propensity score matching
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 |
|---|---|---|
| QuestionnaireA clinical sweep follow up will be performed in all patients of both groups and results will be analyzed. It will be in form of a standardized questionnaire and if necessary telephone interviews asking about thrombo-embolic events, stroke, death, any bleeding but also on their current medication, comorbidities (i.e. arterial hypertension, diabetes mellitus, renal impairment and liver disease), any hospitalizations and their quality of life. For all events, the source documents will be gathered from general physicians, cardiologists, hospitals or registry offices. The questionnaire will be sent by mail to the patients. If information is missing or unclear, patients and if necessary their treating physician will be contacted by phone. | Other | A: patients on anticoagulation, B: patients treated by LAA-Closure |
Primary outcome
Number of intermedium-term clinical outcomes, including thromboembolic events and bleeding complications in patients receiving Amplatzer devices vs. propensity score matched patients treated with OAC.
Time frame: Clinical sweep follow up, the mean follow-up will be approximately 3 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 Jan 2017.
- Background: PubMed 25399274Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
- Background: PubMed 23583249Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.
- Background: PubMed 25604089Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbacker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzaghi M, Vermeersch P, Stock F, Stolcova M, Costa M, Ibrahim R, Schillinger W, Meier B, Park JW. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2016 Feb;11(10):1170-9. doi: 10.4244/EIJY15M01_06.
- Background: PubMed 23412815Nietlispach F, Gloekler S, Krause R, Shakir S, Schmid M, Khattab AA, Wenaweser P, Windecker S, Meier B. Amplatzer left atrial appendage occlusion: single center 10-year experience. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):283-9. doi: 10.1002/ccd.24872. Epub 2013 Mar 22.
- 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.
Steffen Gloeckler, PD Dr. med principal investigator
University hospital Berne
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Insel Gruppe AG, University Hospital Bern.
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 2 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 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of intermedium-term clinical outcomes, including thromboembolic events and bleeding complications in patients receiving Amplatzer devices vs. propensity score matched patients treated with OAC. (time frame: Clinical sweep follow up, the mean follow-up will be approximately 3 years). 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 NCT02787525, which also lists 4 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 Jan 2017.