Atrial FibrillationLAACablationNCT03788941
Left Atrial Appendage Closure in Combination With Catheter Ablation
An observational study of Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- left atrial appendage closure and catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2024
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. History of paroxysmal/persistent/longstanding persistent atrial fibrillation 2. Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs; 3. With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation 4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3 5. Provide informed consent to participate in the study; 6. Between 18-90 years
Who may be able to join
- History of paroxysmal/persistent/longstanding persistent atrial fibrillation
- Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs;
- With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation
- CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
- Provide informed consent to participate in the study;
- Between 18-90 years
Who cannot join
- myocardial infarction within 3 months
- Stroke or systemic embolism within 3 months
- Plan to receive heart transplantation;
- Life expectancy less than 1 year;
- Severe bleeding diseases that cannot be treated with short-term anticoagulants;
- With left atrial or left atrial appendage thrombus;
Show all 10Show fewer
- With uncontrolled malignant tumor ;
- Obvious liver and kidney dysfunction (ALT, AST more than 2 times the upper limit of normal, or CCr <50%);
- Women who are pregnant, or breastfeeding.
- Other conditions not suitable to the combined procedure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200092
Mu Chen, +86 021 25077275, chenmu@xinhuamed.com.cn
About this study
Official title: The Efficacy and Safety of Left Atrial Appendage Closure in Combination With Catheter Ablation in Patients With Atrial Fibrillation
This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.
Read the detailed description
This study is a prospective cohort investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in patients with atrial fibrillation.
This study will be conducted in accordance with the following procedures:
- Screen out patients in accordance with the inclusion and exclusion criteria. The following assessments should be made: demographic data, medical history, physical examination, vital signs data, the height and body weight, laboratory parameters, ECG examination, assessment for medication and evaluation for inclusion/exclusion criteria.
- Participants receive radiofrequency ablation in combination with left atrial appendage closure. Participants will be assessed and observed carefully during and after the operation.
- The participants will be followed-up in the third, ninth and twelfth months after the treatments. The main follow-up includes the review of ECG, 24h Holter monitoring, echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms will also be observed and recorded. The incidence of stroke, systemic embolism, transient ischemic attack, major bleeding and all-cause death; the rate of patients maintaining sinus rhythm, hospitalization due to heart failure, and perioperative complications such as pericardial tamponade, wound hematoma and long-term surgery-related complications will be recorded. Adverse events during the trial will also be assessed and recorded.
- Conditions
- Atrial Fibrillation
- Being tested
- left atrial appendage closure and catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left atrial appendage closure and catheter ablationProcedure or surgery
Also called left atrial appendage occlusion; radiofrequency ablation
Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF).
Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation.
| Study group | Role | What they receive |
|---|---|---|
| LAAC plus Catheter ablation | Patients will receive both left atrial appendage closure and catheter ablation of atrial fibrillation for treatment. Receives: Procedure: left atrial appendage closure and catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke/TIA/systemic embolism
The incidence of stroke/TIA events in the participants will be reported. Participants with clinical manifestations of stroke/TIA will undergo neurological examination and CT scans for diagnosis.
Measured: long-term after the procedure.
Major bleeding
The incidence of major bleeding in the participants will be reported.
Measured: long-term after the procedure.
Death
all-cause death
Measured: long-term after the procedure.
Secondary outcomes (3)
maintenance of sinus rhythm
This refers to the percentage of patients who maintain sinus rhythm after catheter ablation or catheter ablation in combination with left atrial appendage closure. Electrocardiogram can be used to diagnose sinus rhythm or arrhythmias.
Measured: after the procedure outside the 3-month blanking period
procedure-related complications
These are usually refer to perioperative complications such as cardiac tamponade, lesion hematoma and pseudoaneurysm et al. which are related to the manipulation of operator. Diagnostic ultrasound imaging can efficiently identify these complications.
Measured: after the procedure.
Heart failure rehospitalization
acute heart failure leading to hospitalization
Measured: after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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 Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Gang Li, Dr., Principal investigator, Xinhua Hospital, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788941
- Sponsor's protocol ID
- XH-18-015
- Acronym
- LAACablation
- Status last verified
- Oct 2022
- First submitted
- 17 Dec 2018
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bjorck S, Palaszewski B, Friberg L, Bergfeldt L. Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population-based study. Stroke. 2013 Nov;44(11):3103-8. doi: 10.1161/STROKEAHA.113.002329. Epub 2013 Aug 27.
PubMed 23982711Haim M, Hoshen M, Reges O, Rabi Y, Balicer R, Leibowitz M. Prospective national study of the prevalence, incidence, management and outcome of a large contemporary cohort of patients with incident non-valvular atrial fibrillation. J Am Heart Assoc. 2015 Jan 21;4(1):e001486. doi: 10.1161/JAHA.114.001486.
PubMed 25609415Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
PubMed 9737513Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.
PubMed 12401529Andersson T, Magnuson A, Bryngelsson IL, Frobert O, Henriksson KM, Edvardsson N, Poci D. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: a Swedish nationwide long-term case-control study. Eur Heart J. 2013 Apr;34(14):1061-7. doi: 10.1093/eurheartj/ehs469. Epub 2013 Jan 14.
PubMed 23321349Di Biase L, Mohanty P, Mohanty S, Santangeli P, Trivedi C, Lakkireddy D, Reddy M, Jais P, Themistoclakis S, Dello Russo A, Casella M, Pelargonio G, Narducci ML, Schweikert R, Neuzil P, Sanchez J, Horton R, Beheiry S, Hongo R, Hao S, Rossillo A, Forleo G, Tondo C, Burkhardt JD, Haissaguerre M, Natale A. Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device: Results From the AATAC Multicenter Randomized Trial. Circulation. 2016 Apr 26;133(17):1637-44. doi: 10.1161/CIRCULATIONAHA.115.019406. Epub 2016 Mar 30.
PubMed 27029350Hu H, Cui K, Jiang J, Fu H, Zeng R. Safety and efficacy analysis of one-stop intervention for treating nonvalvular atrial fibrillation. Pacing Clin Electrophysiol. 2018 Jan;41(1):28-34. doi: 10.1111/pace.13250. Epub 2017 Dec 28.
PubMed 29194654Phillips KP, Pokushalov E, Romanov A, Artemenko S, Folkeringa RJ, Szili-Torok T, Senatore G, Stein KM, Razali O, Gordon N, Boersma LVA. Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up. Europace. 2018 Jun 1;20(6):949-955. doi: 10.1093/europace/eux183.
PubMed 29106523Lemola K, Sneider M, Desjardins B, Case I, Chugh A, Hall B, Cheung P, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Effects of left atrial ablation of atrial fibrillation on size of the left atrium and pulmonary veins. Heart Rhythm. 2004 Nov;1(5):576-81. doi: 10.1016/j.hrthm.2004.07.020.
PubMed 15851222Perea RJ, Tamborero D, Mont L, De Caralt TM, Ortiz JT, Berruezo A, Matiello M, Sitges M, Vidal B, Sanchez M, Brugada J. Left atrial contractility is preserved after successful circumferential pulmonary vein ablation in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2008 Apr;19(4):374-9. doi: 10.1111/j.1540-8167.2007.01086.x. Epub 2008 Feb 4.
PubMed 18266672Luani B, Groscheck T, Genz C, Tanev I, Rauwolf T, Herold J, Medunjanin S, Schmeisser A, Braun-Dullaeus RC. Left atrial enlargement and clinical considerations in patients with or without a residual interatrial shunt after closure of the left atrial appendage with the WATCHMAN-device. BMC Cardiovasc Disord. 2017 Dec 12;17(1):294. doi: 10.1186/s12872-017-0728-6.
PubMed 29233088Holmes 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 24998121Yao PC, Chen M, Wang QS, Yang M, Zhang R, Zhang PP, Li W, Zhao Y, Lian XM, Wang Q, Fei YD, Wei ZX, Yang XM, Cai XX, Sun J, Li YG. Left Atrial Appendage Electrical Isolation Reduces Residual Patency After Device Closure in Patients With Persistent Atrial Fibrillation. J Am Heart Assoc. 2026 Jun 16;15(12):e046374. doi: 10.1161/JAHA.125.046374. Epub 2026 Jun 15.
PubMed 42294778Chen M, Yao PC, Fei ZT, Wang QS, Yu YC, Zhang PP, Li W, Zhang R, Mo BF, Zhao MZ, Yu Y, Yang M, Zhao Y, Gong CQ, Sun J, Li YG. Prognostic Impact of Left Atrial Appendage Patency After Device Closure. Circ Cardiovasc Interv. 2024 May;17(5):e013579. doi: 10.1161/CIRCINTERVENTIONS.123.013579. Epub 2024 Apr 17.
PubMed 38629273Yao PC, Fei ZT, Chen M, Mo BF, Zhang R, Yang YL, Sun J, Wang QS, Li YG. Incidence, impact and predictors of residual device patency after left atrial appendage closure with the LACbes device. Int J Cardiol. 2024 Feb 15;397:131640. doi: 10.1016/j.ijcard.2023.131640. Epub 2023 Dec 6.
PubMed 38065326
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Left Atrial Appendage Closure in Combination With Catheter Ablation in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03788941
- Acronym / sponsor ID
- LAACablation / XH-18-015
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Dec 2018 (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.
This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.
Detailed description
This study is a prospective cohort investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in patients with atrial fibrillation.
This study will be conducted in accordance with the following procedures:
- Screen out patients in accordance with the inclusion and exclusion criteria. The following assessments should be made: demographic data, medical history, physical examination, vital signs data, the height and body weight, laboratory parameters, ECG examination, assessment for medication and evaluation for inclusion/exclusion criteria.
- Participants receive radiofrequency ablation in combination with left atrial appendage closure. Participants will be assessed and observed carefully during and after the operation.
- The participants will be followed-up in the third, ninth and twelfth months after the treatments. The main follow-up includes the review of ECG, 24h Holter monitoring, echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms will also be observed and recorded. The incidence of stroke, systemic embolism, transient ischemic attack, major bleeding and all-cause death; the rate of patients maintaining sinus rhythm, hospitalization due to heart failure, and perioperative complications such as pericardial tamponade, wound hematoma and long-term surgery-related complications will be recorded. Adverse events during the trial will also be assessed and recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAAC plus Catheter ablation | – | Procedure: left atrial appendage closure and catheter ablationPatients will receive both left atrial appendage closure and catheter ablation of atrial fibrillation for treatment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. History of paroxysmal/persistent/longstanding persistent atrial fibrillation 2. Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs; 3. With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation 4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3 5. Provide informed consent to participate in the study; 6. Between 18-90 years
Key inclusion criteria (6 listed)
- History of paroxysmal/persistent/longstanding persistent atrial fibrillation
- Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs;
- With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation
- CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
- Provide informed consent to participate in the study;
Key exclusion criteria (10 listed)
- myocardial infarction within 3 months
- Stroke or systemic embolism within 3 months
- Plan to receive heart transplantation;
- Life expectancy less than 1 year;
- Severe bleeding diseases that cannot be treated with short-term anticoagulants;
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 closure and catheter ablationAlso: left atrial appendage occlusion; radiofrequency ablationLeft atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF). Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation. | Procedure or surgery | LAAC plus Catheter ablation |
Primary outcome
stroke/TIA/systemic embolism
Time frame: long-term after the procedure.
The incidence of stroke/TIA events in the participants will be reported. Participants with clinical manifestations of stroke/TIA will undergo neurological examination and CT scans for diagnosis.
Major bleeding
Time frame: long-term after the procedure.
The incidence of major bleeding in the participants will be reported.
Death
Time frame: long-term after the procedure.
all-cause death
3 secondary outcomes
maintenance of sinus rhythm
Time frame: after the procedure outside the 3-month blanking period
procedure-related complications
Time frame: after the procedure.
Heart failure rehospitalization
Time frame: after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Results publication: PubMed 23982711Bjorck S, Palaszewski B, Friberg L, Bergfeldt L. Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population-based study. Stroke. 2013 Nov;44(11):3103-8. doi: 10.1161/STROKEAHA.113.002329. Epub 2013 Aug 27.
- Results publication: PubMed 25609415Haim M, Hoshen M, Reges O, Rabi Y, Balicer R, Leibowitz M. Prospective national study of the prevalence, incidence, management and outcome of a large contemporary cohort of patients with incident non-valvular atrial fibrillation. J Am Heart Assoc. 2015 Jan 21;4(1):e001486. doi: 10.1161/JAHA.114.001486.
- Results publication: PubMed 9737513Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
- Results publication: PubMed 12401529Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.
- Results publication: PubMed 23321349Andersson T, Magnuson A, Bryngelsson IL, Frobert O, Henriksson KM, Edvardsson N, Poci D. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: a Swedish nationwide long-term case-control study. Eur Heart J. 2013 Apr;34(14):1061-7. doi: 10.1093/eurheartj/ehs469. Epub 2013 Jan 14.
- Results publication: PubMed 27029350Di Biase L, Mohanty P, Mohanty S, Santangeli P, Trivedi C, Lakkireddy D, Reddy M, Jais P, Themistoclakis S, Dello Russo A, Casella M, Pelargonio G, Narducci ML, Schweikert R, Neuzil P, Sanchez J, Horton R, Beheiry S, Hongo R, Hao S, Rossillo A, Forleo G, Tondo C, Burkhardt JD, Haissaguerre M, Natale A. Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device: Results From the AATAC Multicenter Randomized Trial. Circulation. 2016 Apr 26;133(17):1637-44. doi: 10.1161/CIRCULATIONAHA.115.019406. Epub 2016 Mar 30.
- Results publication: PubMed 29194654Hu H, Cui K, Jiang J, Fu H, Zeng R. Safety and efficacy analysis of one-stop intervention for treating nonvalvular atrial fibrillation. Pacing Clin Electrophysiol. 2018 Jan;41(1):28-34. doi: 10.1111/pace.13250. Epub 2017 Dec 28.
- Results publication: PubMed 29106523Phillips KP, Pokushalov E, Romanov A, Artemenko S, Folkeringa RJ, Szili-Torok T, Senatore G, Stein KM, Razali O, Gordon N, Boersma LVA. Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up. Europace. 2018 Jun 1;20(6):949-955. doi: 10.1093/europace/eux183.
- Results publication: PubMed 15851222Lemola K, Sneider M, Desjardins B, Case I, Chugh A, Hall B, Cheung P, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Effects of left atrial ablation of atrial fibrillation on size of the left atrium and pulmonary veins. Heart Rhythm. 2004 Nov;1(5):576-81. doi: 10.1016/j.hrthm.2004.07.020.
- Results publication: PubMed 18266672Perea RJ, Tamborero D, Mont L, De Caralt TM, Ortiz JT, Berruezo A, Matiello M, Sitges M, Vidal B, Sanchez M, Brugada J. Left atrial contractility is preserved after successful circumferential pulmonary vein ablation in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2008 Apr;19(4):374-9. doi: 10.1111/j.1540-8167.2007.01086.x. Epub 2008 Feb 4.
- Results publication: PubMed 29233088Luani B, Groscheck T, Genz C, Tanev I, Rauwolf T, Herold J, Medunjanin S, Schmeisser A, Braun-Dullaeus RC. Left atrial enlargement and clinical considerations in patients with or without a residual interatrial shunt after closure of the left atrial appendage with the WATCHMAN-device. BMC Cardiovasc Disord. 2017 Dec 12;17(1):294. doi: 10.1186/s12872-017-0728-6.
- Results publication: 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.
- Individual participant dataSharing planned: Undecided
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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.
Yi-Gang Li, Dr. principal investigator
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
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, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 6 inclusion and 10 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 19 Jan 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mu Chen, Dr. (86 021 25077275, chenmu@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke/TIA/systemic embolism (time frame: long-term after the procedure.). The study lists 3 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 NCT03788941, which also lists 18 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 19 Jan 2023.