Atrial FibrillationNCT04628078
LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure
An observational study of Atrial Fibrillation and Cardiovascular Diseases, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Cardiovascular Diseases, Thromboembolism
- What is being tested?
- Use of echocardiography guidance for LAAC
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Aug 2015to 1 Jun 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are scheduled to undergo to an elective Left Atrial Appendage Closure
Who may be able to join
- Age> 18
- Written informed consent to participate in the study
- Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are planned for an elective LAA-closure
- Anatomic characteristics allow placement of a CE marked device, dedicated for LAAC
Who cannot join
- None. Considering the nature of the project, which is to prospectively collect information on all patients treated with LAAC in our center, we will only exclude patients unwilling to sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Bern University Hospital Inselspital
Bern, 3010
Lorenz Räber, Prof., +41 31 632 09 29, lorenz.raeber@insel.ch
About this study
The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations.
Read the detailed description
Percutaneous left atrial appendage closure (LAAC) has established itself in clinical practice as a safe and efficient therapeutic option for atrial fibrillation patients with a relative/absolute contraindication to oral anticoagulation. The purpose of this observational study is to prospectively collect procedural and follow-up data of all patients submitted to a clinically indicate LAAC in order to assess the impact of patient characteristics, procedural technique (imaging used to guide/plan procedure, device implanted, post-procedural drug regimens, etc.) on procedural safety and efficacy. The endpoints will be assessed by means of clinical follow-up at 1-3-5 years after LAAC and imaging exams (TEE at1-3 months, CCTA at 1-13months).
- Being tested
- Use of echocardiography guidance for LAAC
- Keywords
- Left atrial appendage closure, Amulet, Watchman, Watchman flx, Acp, Cardiac computed tomography angiography, Transesophageal echocardiography, Peridevice leak, Thromboembolic events, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Cardiovascular Diseases, Thromboembolism, Cerebral Palsy, Ataxic, Autosomal Recessive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of echocardiography guidance for LAACOther
Since August 2015, the echocardiography is routinely used by majority of operators to guide LAAC
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Composite of Death, cerebrovascular events, cardiac tamponade, need for urgent surgery, need for cardiopulmonary resuscitation, device embolization, non vascular access-related major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) or acute kidney injury.
Measured: 7 days
Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism
Protection from cardiovascular death, ischemic stroke and systemic embolism
Measured: 1 to 5 Years
Secondary Efficacy Endpoint - Incidence of technical success
Technical success defined as adequate LAA ostium closure (without residual PDL>5mm or patent lobes) in absence of device complications (according to the Munich Consensus Document)
Measured: 7 days to 13 months
Feasibility Endpoint - Total procedure time (min)
Total procedure time (min)
Measured: During the LAAC Procedure (≃ 60 minutes )
Feasibility Endpoint - dose of contrast medium (ml)
dose of contrast medium (ml)
Measured: During the LAAC Procedure (≃ 60 minutes )
Feasibility Endpoint - dose of x-ray (cGy.cm2)
dose of x-ray (cGy.cm2)
Measured: During the LAAC Procedure (≃ 60 minutes )
Feasibility Endpoint - number of device implantation attempt during the procedure (number)
number of device implantation attempt during the procedure (number)
Measured: During the LAAC Procedure (≃ 60 minutes )
Feasibility Endpoint - number of device change during the procedure (number)
number of device change during the procedure (number)
Measured: During the LAAC Procedure (≃ 60 minutes )
Net Clinical Benefit Endpoint
Composite of death, stroke, systemic embolism, pulmonary embolism, myocardial infarction, and major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) not procedure-related.
Measured: 1 to 5 years
LAA patency
LAA patency and its subtypes as evaluated by TEE and/or CCTA
Measured: 45 days to 13 months
Device related thrombus
Device related thrombus detected by TEE and /or CCTA on the atrial surface of device
Measured: 45 days to 13months
Secondary outcomes (3)
Percentage of atrial surface of device covered
% (device sealing surrogate)
Measured: 45 days - 3 months - 13months
Maximal Hypoattentuated Thickening on atrial surface of device
mm (device sealing surrogate)
Measured: 45 days - 3 months - 13months
Percentage of device length coverage
% (device sealing surrogate)
Measured: 45 days - 3 months - 13months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start12 Aug 2015
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenz Räber, Prof., Principal investigator, Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628078
- Sponsor's protocol ID
- 2016-01742
- Other IDs
- 2016
- Status last verified
- Feb 2023
- First submitted
- 5 Nov 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
PubMed 24352519Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
PubMed 24449944Gloekler S, Meier B, Windecker S. Left atrial appendage closure for prevention of cardioembolic events. Swiss Med Wkly. 2016 May 31;146:w14298. doi: 10.4414/smw.2016.14298. eCollection 2016.
PubMed 27244534Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996 Feb;61(2):755-9. doi: 10.1016/0003-4975(95)00887-X.
PubMed 8572814Holmes 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 26088300Reddy 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 25399274Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.
PubMed 24998121Koskinas KC, Shakir S, Fankhauser M, Nietlispach F, Attinger-Toller A, Moschovitis A, Wenaweser P, Pilgrim T, Stortecky S, Praz F, Raber L, Windecker S, Meier B, Gloekler S. Predictors of Early (1-Week) Outcomes Following Left Atrial Appendage Closure With Amplatzer Devices. JACC Cardiovasc Interv. 2016 Jul 11;9(13):1374-83. doi: 10.1016/j.jcin.2016.04.019.
PubMed 27388826Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X.
PubMed 19683639Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012 Oct;33(19):2403-18. doi: 10.1093/eurheartj/ehs255.
PubMed 23026477Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
PubMed 21670242Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomstrom-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18.
PubMed 27540038Galea R, Bini T, Krsnik JP, Touray M, Temperli FG, Kassar M, Papadis A, Gloeckler S, Brugger N, Madhkour R, Seiffge DJ, Roten L, Siontis GCM, Heg D, Windecker S, Raber L. Pericardial Effusion After Left Atrial Appendage Closure: Timing, Predictors, and Clinical Impact. JACC Cardiovasc Interv. 2024 Jun 10;17(11):1295-1307. doi: 10.1016/j.jcin.2024.01.310. Epub 2024 May 22.
PubMed 38795087
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure
- ClinicalTrials.gov ID
- NCT04628078
- Acronym / sponsor ID
- 2016-01742
- Keywords
- Left atrial appendage closure, Amulet, Watchman, Watchman flx, Acp, Cardiac computed tomography angiography, Transesophageal echocardiography, Peridevice leak
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 12 Aug 2015 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 13 Nov 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.
The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations.
Detailed description
Percutaneous left atrial appendage closure (LAAC) has established itself in clinical practice as a safe and efficient therapeutic option for atrial fibrillation patients with a relative/absolute contraindication to oral anticoagulation. The purpose of this observational study is to prospectively collect procedural and follow-up data of all patients submitted to a clinically indicate LAAC in order to assess the impact of patient characteristics, procedural technique (imaging used to guide/plan procedure, device implanted, post-procedural drug regimens, etc.) on procedural safety and efficacy. The endpoints will be assessed by means of clinical follow-up at 1-3-5 years after LAAC and imaging exams (TEE at1-3 months, CCTA at 1-13months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are scheduled to undergo to an elective Left Atrial Appendage Closure
Key inclusion criteria (4 listed)
- Age> 18
- Written informed consent to participate in the study
- Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are planned for an elective LAA-closure
- Anatomic characteristics allow placement of a CE marked device, dedicated for LAAC
Key exclusion criteria (1 listed)
- None. Considering the nature of the project, which is to prospectively collect information on all patients treated with LAAC in our center, we will only exclude patients unwilling to sign the informed consent.
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 |
|---|---|---|
| Use of echocardiography guidance for LAACSince August 2015, the echocardiography is routinely used by majority of operators to guide LAAC | Other | – |
Primary outcome
Primary Safety Endpoint
Time frame: 7 days
Composite of Death, cerebrovascular events, cardiac tamponade, need for urgent surgery, need for cardiopulmonary resuscitation, device embolization, non vascular access-related major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) or acute kidney injury.
Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism
Time frame: 1 to 5 Years
Protection from cardiovascular death, ischemic stroke and systemic embolism
Secondary Efficacy Endpoint - Incidence of technical success
Time frame: 7 days to 13 months
Technical success defined as adequate LAA ostium closure (without residual PDL>5mm or patent lobes) in absence of device complications (according to the Munich Consensus Document)
Feasibility Endpoint - Total procedure time (min)
Time frame: During the LAAC Procedure (≃ 60 minutes )
Total procedure time (min)
Feasibility Endpoint - dose of contrast medium (ml)
Time frame: During the LAAC Procedure (≃ 60 minutes )
dose of contrast medium (ml)
Feasibility Endpoint - dose of x-ray (cGy.cm2)
Time frame: During the LAAC Procedure (≃ 60 minutes )
dose of x-ray (cGy.cm2)
Feasibility Endpoint - number of device implantation attempt during the procedure (number)
Time frame: During the LAAC Procedure (≃ 60 minutes )
number of device implantation attempt during the procedure (number)
Feasibility Endpoint - number of device change during the procedure (number)
Time frame: During the LAAC Procedure (≃ 60 minutes )
number of device change during the procedure (number)
Net Clinical Benefit Endpoint
Time frame: 1 to 5 years
Composite of death, stroke, systemic embolism, pulmonary embolism, myocardial infarction, and major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) not procedure-related.
LAA patency
Time frame: 45 days to 13 months
LAA patency and its subtypes as evaluated by TEE and/or CCTA
Device related thrombus
Time frame: 45 days to 13months
Device related thrombus detected by TEE and /or CCTA on the atrial surface of device
3 secondary outcomes
Percentage of atrial surface of device covered
Time frame: 45 days - 3 months - 13months
Maximal Hypoattentuated Thickening on atrial surface of device
Time frame: 45 days - 3 months - 13months
Percentage of device length coverage
Time frame: 45 days - 3 months - 13months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Background: PubMed 24352519Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
- Background: PubMed 24449944Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
- Background: PubMed 27244534Gloekler S, Meier B, Windecker S. Left atrial appendage closure for prevention of cardioembolic events. Swiss Med Wkly. 2016 May 31;146:w14298. doi: 10.4414/smw.2016.14298. eCollection 2016.
- Background: PubMed 8572814Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996 Feb;61(2):755-9. doi: 10.1016/0003-4975(95)00887-X.
- Background: 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.
- 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 24998121Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.
- Background: PubMed 27388826Koskinas KC, Shakir S, Fankhauser M, Nietlispach F, Attinger-Toller A, Moschovitis A, Wenaweser P, Pilgrim T, Stortecky S, Praz F, Raber L, Windecker S, Meier B, Gloekler S. Predictors of Early (1-Week) Outcomes Following Left Atrial Appendage Closure With Amplatzer Devices. JACC Cardiovasc Interv. 2016 Jul 11;9(13):1374-83. doi: 10.1016/j.jcin.2016.04.019.
- Background: PubMed 19683639Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X.
- Background: PubMed 23026477Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012 Oct;33(19):2403-18. doi: 10.1093/eurheartj/ehs255.
- Background: PubMed 21670242Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
- Background: PubMed 27540038Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomstrom-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18.
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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.
Lorenz Räber, Prof. principal investigator
Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie
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 Cardiovascular Diseases, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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: looking for participants now, as of the sponsor's last update on 22 Feb 2023. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenz Räber, Prof. (31 632 09 29 ext. +41, lorenz.raeber@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 7 days). The study lists 11 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 NCT04628078, which also lists 13 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 22 Feb 2023.