Device OcclusionLAAOHFNCT04472871
Feasibility and Prognosis of Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation
An observational study of Device Occlusion, run by Assiut University.
Trial summary
Study hypotheses is that in patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefore a higher rate of stroke and embolism are observed even on oral anticoagulants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Device Occlusion
- What is being tested?
- Left atrial appendage closure
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2020to 1 Jul 2021
- 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: All patients underwent left atrial appendage closure in Assiut university in the period from January 2014 to December 2019 will be included. In this retrospective cohort study, atrial fibrillation patients with previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants who were scheduled for transcatheter left atrial appendage closure are included
Who may be able to join
- In this study,
- Atrial fibrillation patients with previous major bleeding.
- Atrial fibrillation patients with previous bleeding predisposition
- Atrial fibrillation patients with previous contraindications for oral anticoagulants scheduled for transcatheter left atrial appendage closure are included.
Who cannot join
- Patients having no data for follow up after the procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility and Prognostic Role of Percutaneous Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation at High Risk for Cerebrovascular Events
Study hypotheses is that in patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefore a higher rate of stroke and embolism are observed even on oral anticoagulants.
Therefore The left atrial appendage closure (LAAC) procedure's benefit in patients with an impaired left ventricular ejection fraction (LVEF) has to be investigated So the study is to assess the safety and prognosis of left atrial appendage closure (LAAC) in patients with heart failure in preventing thromboembolic events, bleeding and all-cause mortality.
Patients will be divided into to groups, one group includes patients with no evidence of heart failure, and another group including patients with previous history of or with an evidence of with heart failure.
Read the detailed description
Patients selection All patients underwent left atrial appendage closure in Assiut university in the period from January 2014 to December 2019 will be included.
Inclusion criteria In this retrospective cohort study, atrial fibrillation patients with previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants scheduled for transcatheter left atrial appendage closure are included.
Methods In this retrospective cohort study
- All patients with previous major bleeding or a bleeding predisposition scheduled for transcatheter LAAC in Assiut university in the period from January 2014 to December 2019 will be included.
- All devices used in for LAAC in this period will be included (WATCHMAN, Amulet, LARIAT and Lambre)
- CHA2DS2-VASC, CHADS, HAS-BLED scores will be calculated for all patients.
- Patients will be divided into to groups, one group includes patients with no evidence of heart failure, and another group including patients with previous history of or with an evidence of with heart failure.
- Heart failure will be defined as patients with left ventricular ejection fraction ≤ 35%.
- New York Heart Association (NYHA) classification will be determined for all patient graded from I-IV.
- Both groups will be compared regarding procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm), the absence of any complication related to the intervention, major and minor bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient ischemic attack, systemic embolization during follow-up.
- Device related thrombus (DRT) will be compared in both groups according to the results of transesophageal echo (TOE) 6 weeks post procedure.
Primary endpoint
- The primary endpoints of the study are procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm), the absence of any complication related to the intervention, bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient ischemic attack, systemic embolization during follow-up in both groups of patients with heart failure and without heart failure.
- Conditions
- Device Occlusion
- Being tested
- Left atrial appendage closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial appendage closureDevice
The left atrial appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium (top left chamber of the heart). It is unclear what function, if any, the LAA performs. In patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefor a higher rate of stroke and embolism are observed even on oral anticoagulants. FDA approved devices for left atrial appendage closure will be used under guidance of angiography and trans-esophageal echo with highly efficient and trained personnel.
| Study group | Role | What they receive |
|---|---|---|
| patients with atrial fibrillation and heart failure | Patients with cardiac function ejection fraction less than 35% and underwent Left atrial appendage closure in the period covered by the study Receives: Device: Left atrial appendage closure | |
| patients with atrial fibrillation without heart failure | Patients with cardiac function ejection fraction more than 35% and underwent Left atrial appendage closure in the period covered by the study Receives: Device: Left atrial appendage closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedural success
procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm) The study will assess the rate of procedural success in both groups of the study.
Measured: 6 weeks post procedure
the absence of any complication related to the intervention
Post procedural Complications including cerebrovascular stroke, bleeding and all cause mortality will be compared in both groups of the study to assess the prognosis of the procedure in these groups.
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start20 Jul 2020 (estimated)
- Primary completion15 Mar 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Device OcclusionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Osman Abdelhamead, Assiut University
- Investigators
- Mohamed A Osman, Ass. lect., Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472871
- Sponsor's protocol ID
- LAA closure in heart failure
- Acronym
- LAAOHF
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.
PubMed 23325525Holmes DR Jr, Doshi SK, Kar S, Price MJ, Sanchez JM, Sievert H, Valderrabano M, Reddy VY. Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis. J Am Coll Cardiol. 2015 Jun 23;65(24):2614-2623. doi: 10.1016/j.jacc.2015.04.025.
PubMed 26088300Saw J. Long-Term Results With Left Atrial Appendage Closure: Watching the Watchman. J Am Coll Cardiol. 2017 Dec 19;70(24):2976-2978. doi: 10.1016/j.jacc.2017.10.056. Epub 2017 Nov 2. No abstract available.
PubMed 29104013Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.
PubMed 29103847Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
PubMed 27567408Ellis CR, Kanagasundram AN. Atrial Fibrillation in Heart Failure: Left Atrial Appendage Management. Cardiol Clin. 2019 May;37(2):241-249. doi: 10.1016/j.ccl.2019.01.009. Epub 2019 Feb 13.
PubMed 30926025
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Prognostic Role of Percutaneous Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation at High Risk for Cerebrovascular Events
- ClinicalTrials.gov ID
- NCT04472871
- Acronym / sponsor ID
- LAAOHF / LAA closure in heart failure
- Conditions
- Device Occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (estimated)
- Primary completion
- 15 Mar 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 16 Jul 2020 (actual)
- 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.
Study hypotheses is that in patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefore a higher rate of stroke and embolism are observed even on oral anticoagulants.
Therefore The left atrial appendage closure (LAAC) procedure's benefit in patients with an impaired left ventricular ejection fraction (LVEF) has to be investigated So the study is to assess the safety and prognosis of left atrial appendage closure (LAAC) in patients with heart failure in preventing thromboembolic events, bleeding and all-cause mortality.
Patients will be divided into to groups, one group includes patients with no evidence of heart failure, and another group including patients with previous history of or with an evidence of with heart failure.
Detailed description
Patients selection All patients underwent left atrial appendage closure in Assiut university in the period from January 2014 to December 2019 will be included.
Inclusion criteria In this retrospective cohort study, atrial fibrillation patients with previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants scheduled for transcatheter left atrial appendage closure are included.
Methods In this retrospective cohort study
- All patients with previous major bleeding or a bleeding predisposition scheduled for transcatheter LAAC in Assiut university in the period from January 2014 to December 2019 will be included.
- All devices used in for LAAC in this period will be included (WATCHMAN, Amulet, LARIAT and Lambre)
- CHA2DS2-VASC, CHADS, HAS-BLED scores will be calculated for all patients.
- Patients will be divided into to groups, one group includes patients with no evidence of heart failure, and another group including patients with previous history of or with an evidence of with heart failure.
- Heart failure will be defined as patients with left ventricular ejection fraction ≤ 35%.
- New York Heart Association (NYHA) classification will be determined for all patient graded from I-IV.
- Both groups will be compared regarding procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm), the absence of any complication related to the intervention, major and minor bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient ischemic attack, systemic embolization during follow-up.
- Device related thrombus (DRT) will be compared in both groups according to the results of transesophageal echo (TOE) 6 weeks post procedure.
Primary endpoint
- The primary endpoints of the study are procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm), the absence of any complication related to the intervention, bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient ischemic attack, systemic embolization during follow-up in both groups of patients with heart failure and without heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with atrial fibrillation and heart failure | – | Device: Left atrial appendage closurePatients with cardiac function ejection fraction less than 35% and underwent Left atrial appendage closure in the period covered by the study |
| patients with atrial fibrillation without heart failure | – | Device: Left atrial appendage closurePatients with cardiac function ejection fraction more than 35% and underwent Left atrial appendage closure in the period covered by the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients underwent left atrial appendage closure in Assiut university in the period from January 2014 to December 2019 will be included. In this retrospective cohort study, atrial fibrillation patients with previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants who were scheduled for transcatheter left atrial appendage closure are included
Key inclusion criteria (4 listed)
- In this study,
Key exclusion criteria (1 listed)
- Patients having no data for follow up after the procedure
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 closureThe left atrial appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium (top left chamber of the heart). It is unclear what function, if any, the LAA performs. In patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefor a higher rate of stroke and embolism are observed even on oral anticoagulants. FDA approved devices for left atrial appendage closure will be used under guidance of angiography and trans-esophageal echo with highly efficient and trained personnel. | Device | patients with atrial fibrillation and heart failure, patients with atrial fibrillation without heart failure |
Primary outcome
procedural success
Time frame: 6 weeks post procedure
procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm) The study will assess the rate of procedural success in both groups of the study.
the absence of any complication related to the intervention
Time frame: 6 months post intervention
Post procedural Complications including cerebrovascular stroke, bleeding and all cause mortality will be compared in both groups of the study to assess the prognosis of the procedure in these groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Results publication: PubMed 23325525Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.
- Results publication: PubMed 26088300Holmes DR Jr, Doshi SK, Kar S, Price MJ, Sanchez JM, Sievert H, Valderrabano M, Reddy VY. Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis. J Am Coll Cardiol. 2015 Jun 23;65(24):2614-2623. doi: 10.1016/j.jacc.2015.04.025.
- Results publication: PubMed 29104013Saw J. Long-Term Results With Left Atrial Appendage Closure: Watching the Watchman. J Am Coll Cardiol. 2017 Dec 19;70(24):2976-2978. doi: 10.1016/j.jacc.2017.10.056. Epub 2017 Nov 2. No abstract available.
- Results publication: PubMed 29103847Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.
- Results publication: PubMed 27567408Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
- Results publication: PubMed 30926025Ellis CR, Kanagasundram AN. Atrial Fibrillation in Heart Failure: Left Atrial Appendage Management. Cardiol Clin. 2019 May;37(2):241-249. doi: 10.1016/j.ccl.2019.01.009. Epub 2019 Feb 13.
- 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.
Mohamed A Osman, Ass. lect. study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Device Occlusion, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 16 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Osman, Ass. lect. (01061878040, mosman87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procedural success (time frame: 6 weeks post procedure). The study lists 2 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 NCT04472871, which also lists 6 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 16 Jul 2020.