Atrial FibrillationNCT04897204
Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation
A study testing Catheter ablation and left atrial appendage occlusion and Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion in people with Atrial Fibrillation and Left Atrial Appendage, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
This project intends to enroll patients with persistent atrial fibrillation who are planning to undergo catheter ablation of atrial fibrillation. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage, Left Atrial Appendage Occlusion
- What is being tested?
- Catheter ablation and left atrial appendage occlusion and Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years old;
- Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥ 1 week), and is ineffective to one or more anti-arrhythmic drugs;
- CHA2DS2-VASc score ≥ 2 points;
- The patient is ready to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery;
- Provide an informed consent form that is willing to participate in the research, follow-up trials and evaluation procedures.
Who cannot join
- Past left atrial appendage occlusion, atrial fibrillation catheter ablation or surgical ablation history;
- There are plans for cardiac surgery within 90 days;
- Stroke/transient ischemic attack occurred within 30 days;
- Have had atrial septal defect repair or have an ASD/PFO occluder in the body;
- Heart failure NYHA heart function grade IV;
- LVEF<30%;
Show all 10Show fewer
- Combined with other serious diseases, the life expectancy is less than 2 years;
- Within 6 months after cardiac revascularization or other cardiac surgery;
- Women who are pregnant, breastfeeding, planning to become pregnant, or women of childbearing age who have not adopted reliable contraceptive methods;
- Obviously abnormal liver and kidney function and coagulation function;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Randomized Controlled Study of Additonal Left Atrial Appendage Electrical Isolation in Catheter Ablation Combined With Left Atrial Appendage Occlusion of Persistent Atrial Fibrillation
This project intends to enroll patients with persistent atrial fibrillation who are planning to undergo catheter ablation of atrial fibrillation. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. We are intend to evaluate the safety and effectiveness of one-stop operation of left atrial appendage electrical isolation combined with left atrial appendage occlusion in the treatment of persistent atrial fibrillation.
Read the detailed description
This project intends to enroll patients with persistent atrial fibrillation who are planned to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery, and randomly allocate them to the experimental group and the control group at a ratio of 1:1. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. Follow-up for 1 year, compare the differences in the recurrence rate of atrial fibrillation between the two groups of patients, and further compare the differences in clinical events such as stroke, systemic embolism, hospitalization due to heart failure, and cardiovascular death.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Left Atrial Appendage Occlusion, Catheter Ablation
- Being tested
- Catheter ablation and left atrial appendage occlusion, Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion
- Keywords
- Left Atrial Appendage Electrical Isolation, Atrial Fibrillation, 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.
Catheter ablation and left atrial appendage occlusionProcedure or surgery
The patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion.
Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusionProcedure or surgery
These patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion, combined with additional left atrial appendage occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Left Atrial Appendage Electrical Isolation with One-stop treatment of atrial fibrillation | Experimental | The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion and additional left atrial appendage electrical isolation operation. Receives: Procedure: Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion |
| One-stop treatment of atrial fibrillation | Other | The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion. Receives: Procedure: Catheter ablation and left atrial appendage occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrence
outside the 3-month blank period after surgery, ECG and Holter recorded rapid atrial arrhythmia greater than 30S.
Measured: one year after operation
Stroke/TIA
Patients may have cerebral ischemia, such as sudden limb movement and sensory disturbance, aphasia, transient blindness in one eye, etc., disturbance of consciousness, or symptoms of vertebral artery ischemia, such as vertigo, tinnitus, hearing impairment, diplopia, Unsteady gait and difficulty swallowing, etc., patients may have obvious infarcts in the brain, which can be confirmed clinically by CT or MRI.
Measured: one year after operation
Systemic embolism
The clinical manifestations or evidence of embolism in the blood vessels of the system, including renal artery, splenic artery, mesenteric artery, etc. during the follow-up of the patient, and relevant examinations can be used to confirm the diagnosis.
Measured: one year after operation
Hospitalization rate due to heart failure
During the follow-up period, patients need hospitalization for heart failure, including acute heart failure, acute exacerbation of chronic heart failure, etc., which can be combined with clinical symptoms, signs, biochemical examinations (such as NT-proBNP) and cardiac ultrasound Wait for a clear diagnosis.
Measured: one year after operation
Cardiovascular death
The death of a patient due to cardiac structure, function, coronary artery disease, and arrhythmia can be diagnosed in combination with clinical practice.
Measured: one year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897204
- Sponsor's protocol ID
- XH-21-004
- Status last verified
- Apr 2021
- First submitted
- 19 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003 Sep 11;349(11):1019-26. doi: 10.1056/NEJMoa022913.
PubMed 12968085Nyong J, Amit G, Adler AJ, Owolabi OO, Perel P, Prieto-Merino D, Lambiase P, Casas JP, Morillo CA. Efficacy and safety of ablation for people with non-paroxysmal atrial fibrillation. Cochrane Database Syst Rev. 2016 Nov 22;11(11):CD012088. doi: 10.1002/14651858.CD012088.pub2.
PubMed 27871122Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
PubMed 25946280Di Biase L, Burkhardt JD, Mohanty P, Mohanty S, Sanchez JE, Trivedi C, Gunes M, Gokoglan Y, Gianni C, Horton RP, Themistoclakis S, Gallinghouse GJ, Bailey S, Zagrodzky JD, Hongo RH, Beheiry S, Santangeli P, Casella M, Dello Russo A, Al-Ahmad A, Hranitzky P, Lakkireddy D, Tondo C, Natale A. Left Atrial Appendage Isolation in Patients With Longstanding Persistent AF Undergoing Catheter Ablation: BELIEF Trial. J Am Coll Cardiol. 2016 Nov 1;68(18):1929-1940. doi: 10.1016/j.jacc.2016.07.770.
PubMed 27788847Romero J, Michaud GF, Avendano R, Briceno DF, Kumar S, Carlos Diaz J, Mohanty S, Trivedi C, Gianni C, Della Rocca D, Proietti R, Perrotta L, Bordignon S, Chun JKR, Schmidt B, Garcia M, Natale A, Di Biase L. Benefit of left atrial appendage electrical isolation for persistent and long-standing persistent atrial fibrillation: a systematic review and meta-analysis. Europace. 2018 Aug 1;20(8):1268-1278. doi: 10.1093/europace/eux372.
PubMed 29342299Fink T, Ouyang F, Heeger CH, Sciacca V, Reissmann B, Keelani A, Schutte C, Wohlmuth P, Maurer T, Rottner L, Eitel C, Eitel I, Rillig A, Metzner A, Kuck KH, Tilz RR, Vogler J. Management of thrombus formation after electrical isolation of the left atrial appendage in patients with atrial fibrillation. Europace. 2020 Sep 1;22(9):1358-1366. doi: 10.1093/europace/euaa174.
PubMed 32743641Kim YG, Shim J, Oh SK, Lee KN, Choi JI, Kim YH. Electrical isolation of the left atrial appendage increases the risk of ischemic stroke and transient ischemic attack regardless of postisolation flow velocity. Heart Rhythm. 2018 Dec;15(12):1746-1753. doi: 10.1016/j.hrthm.2018.09.012.
PubMed 30502771Reddy 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 25399274Belgaid DR, Khan Z, Zaidi M, Hobbs A. Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial. Int J Cardiol. 2016 Sep 15;219:177-9. doi: 10.1016/j.ijcard.2016.06.041. Epub 2016 Jun 15.
PubMed 27343417Mo BF, Sun J, Zhang PP, Li W, Chen M, Yuan JL, Yu Y, Wang QS, Li YG. Combined Therapy of Catheter Ablation and Left Atrial Appendage Closure for Patients with Atrial Fibrillation: A Case-Control Study. J Interv Cardiol. 2020 Jun 25;2020:8615410. doi: 10.1155/2020/8615410. eCollection 2020.
PubMed 32669982Panikker S, Jarman JW, Virmani R, Kutys R, Haldar S, Lim E, Butcher C, Khan H, Mantziari L, Nicol E, Foran JP, Markides V, Wong T. Left Atrial Appendage Electrical Isolation and Concomitant Device Occlusion to Treat Persistent Atrial Fibrillation: A First-in-Human Safety, Feasibility, and Efficacy Study. Circ Arrhythm Electrophysiol. 2016 Jul;9(7):e003710. doi: 10.1161/CIRCEP.115.003710.
PubMed 27406602Yorgun H, Canpolat U, Kocyigit D, Coteli C, Evranos B, Aytemir K. Left atrial appendage isolation in addition to pulmonary vein isolation in persistent atrial fibrillation: one-year clinical outcome after cryoballoon-based ablation. Europace. 2017 May 1;19(5):758-768. doi: 10.1093/europace/eux005.
PubMed 28340073
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Additonal Left Atrial Appendage Electrical Isolation in Catheter Ablation Combined With Left Atrial Appendage Occlusion of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04897204
- Acronym / sponsor ID
- XH-21-004
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Left Atrial Appendage Occlusion, Catheter Ablation
- Keywords
- Left Atrial Appendage Electrical Isolation, Atrial Fibrillation, Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 May 2021 (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 project intends to enroll patients with persistent atrial fibrillation who are planning to undergo catheter ablation of atrial fibrillation. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. We are intend to evaluate the safety and effectiveness of one-stop operation of left atrial appendage electrical isolation combined with left atrial appendage occlusion in the treatment of persistent atrial fibrillation.
Detailed description
This project intends to enroll patients with persistent atrial fibrillation who are planned to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery, and randomly allocate them to the experimental group and the control group at a ratio of 1:1. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. Follow-up for 1 year, compare the differences in the recurrence rate of atrial fibrillation between the two groups of patients, and further compare the differences in clinical events such as stroke, systemic embolism, hospitalization due to heart failure, and cardiovascular death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Atrial Appendage Electrical Isolation with One-stop treatment of atrial fibrillation | Experimental | Procedure: Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusionThe patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion and additional left atrial appendage electrical isolation operation. |
| One-stop treatment of atrial fibrillation | Other | Procedure: Catheter ablation and left atrial appendage occlusionThe patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-85 years old;
- Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥ 1 week), and is ineffective to one or more anti-arrhythmic drugs;
- CHA2DS2-VASc score ≥ 2 points;
- The patient is ready to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery;
- Provide an informed consent form that is willing to participate in the research, follow-up trials and evaluation procedures.
Key exclusion criteria (10 listed)
- Past left atrial appendage occlusion, atrial fibrillation catheter ablation or surgical ablation history;
- There are plans for cardiac surgery within 90 days;
- Stroke/transient ischemic attack occurred within 30 days;
- Have had atrial septal defect repair or have an ASD/PFO occluder in the body;
- Heart failure NYHA heart function grade IV;
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 |
|---|---|---|
| Catheter ablation and left atrial appendage occlusionThe patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion. | Procedure or surgery | One-stop treatment of atrial fibrillation |
| Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusionThese patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion, combined with additional left atrial appendage occlusion. | Procedure or surgery | Left Atrial Appendage Electrical Isolation with One-stop treatment of atrial fibrillation |
Primary outcome
Atrial fibrillation recurrence
Time frame: one year after operation
outside the 3-month blank period after surgery, ECG and Holter recorded rapid atrial arrhythmia greater than 30S.
Stroke/TIA
Time frame: one year after operation
Patients may have cerebral ischemia, such as sudden limb movement and sensory disturbance, aphasia, transient blindness in one eye, etc., disturbance of consciousness, or symptoms of vertebral artery ischemia, such as vertigo, tinnitus, hearing impairment, diplopia, Unsteady gait and difficulty swallowing, etc., patients may have obvious infarcts in the brain, which can be confirmed clinically by CT or MRI.
Systemic embolism
Time frame: one year after operation
The clinical manifestations or evidence of embolism in the blood vessels of the system, including renal artery, splenic artery, mesenteric artery, etc. during the follow-up of the patient, and relevant examinations can be used to confirm the diagnosis.
Hospitalization rate due to heart failure
Time frame: one year after operation
During the follow-up period, patients need hospitalization for heart failure, including acute heart failure, acute exacerbation of chronic heart failure, etc., which can be combined with clinical symptoms, signs, biochemical examinations (such as NT-proBNP) and cardiac ultrasound Wait for a clear diagnosis.
Cardiovascular death
Time frame: one year after operation
The death of a patient due to cardiac structure, function, coronary artery disease, and arrhythmia can be diagnosed in combination with clinical practice.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Results publication: PubMed 12968085Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003 Sep 11;349(11):1019-26. doi: 10.1056/NEJMoa022913.
- Results publication: PubMed 27871122Nyong J, Amit G, Adler AJ, Owolabi OO, Perel P, Prieto-Merino D, Lambiase P, Casas JP, Morillo CA. Efficacy and safety of ablation for people with non-paroxysmal atrial fibrillation. Cochrane Database Syst Rev. 2016 Nov 22;11(11):CD012088. doi: 10.1002/14651858.CD012088.pub2.
- Results publication: PubMed 25946280Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
- Results publication: PubMed 27788847Di Biase L, Burkhardt JD, Mohanty P, Mohanty S, Sanchez JE, Trivedi C, Gunes M, Gokoglan Y, Gianni C, Horton RP, Themistoclakis S, Gallinghouse GJ, Bailey S, Zagrodzky JD, Hongo RH, Beheiry S, Santangeli P, Casella M, Dello Russo A, Al-Ahmad A, Hranitzky P, Lakkireddy D, Tondo C, Natale A. Left Atrial Appendage Isolation in Patients With Longstanding Persistent AF Undergoing Catheter Ablation: BELIEF Trial. J Am Coll Cardiol. 2016 Nov 1;68(18):1929-1940. doi: 10.1016/j.jacc.2016.07.770.
- Results publication: PubMed 29342299Romero J, Michaud GF, Avendano R, Briceno DF, Kumar S, Carlos Diaz J, Mohanty S, Trivedi C, Gianni C, Della Rocca D, Proietti R, Perrotta L, Bordignon S, Chun JKR, Schmidt B, Garcia M, Natale A, Di Biase L. Benefit of left atrial appendage electrical isolation for persistent and long-standing persistent atrial fibrillation: a systematic review and meta-analysis. Europace. 2018 Aug 1;20(8):1268-1278. doi: 10.1093/europace/eux372.
- Results publication: PubMed 32743641Fink T, Ouyang F, Heeger CH, Sciacca V, Reissmann B, Keelani A, Schutte C, Wohlmuth P, Maurer T, Rottner L, Eitel C, Eitel I, Rillig A, Metzner A, Kuck KH, Tilz RR, Vogler J. Management of thrombus formation after electrical isolation of the left atrial appendage in patients with atrial fibrillation. Europace. 2020 Sep 1;22(9):1358-1366. doi: 10.1093/europace/euaa174.
- Results publication: PubMed 30502771Kim YG, Shim J, Oh SK, Lee KN, Choi JI, Kim YH. Electrical isolation of the left atrial appendage increases the risk of ischemic stroke and transient ischemic attack regardless of postisolation flow velocity. Heart Rhythm. 2018 Dec;15(12):1746-1753. doi: 10.1016/j.hrthm.2018.09.012.
- Results publication: 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.
- Results publication: PubMed 27343417Belgaid DR, Khan Z, Zaidi M, Hobbs A. Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial. Int J Cardiol. 2016 Sep 15;219:177-9. doi: 10.1016/j.ijcard.2016.06.041. Epub 2016 Jun 15.
- Results publication: PubMed 32669982Mo BF, Sun J, Zhang PP, Li W, Chen M, Yuan JL, Yu Y, Wang QS, Li YG. Combined Therapy of Catheter Ablation and Left Atrial Appendage Closure for Patients with Atrial Fibrillation: A Case-Control Study. J Interv Cardiol. 2020 Jun 25;2020:8615410. doi: 10.1155/2020/8615410. eCollection 2020.
- Results publication: PubMed 27406602Panikker S, Jarman JW, Virmani R, Kutys R, Haldar S, Lim E, Butcher C, Khan H, Mantziari L, Nicol E, Foran JP, Markides V, Wong T. Left Atrial Appendage Electrical Isolation and Concomitant Device Occlusion to Treat Persistent Atrial Fibrillation: A First-in-Human Safety, Feasibility, and Efficacy Study. Circ Arrhythm Electrophysiol. 2016 Jul;9(7):e003710. doi: 10.1161/CIRCEP.115.003710.
- Results publication: PubMed 28340073Yorgun H, Canpolat U, Kocyigit D, Coteli C, Evranos B, Aytemir K. Left atrial appendage isolation in addition to pulmonary vein isolation in persistent atrial fibrillation: one-year clinical outcome after cryoballoon-based ablation. Europace. 2017 May 1;19(5):758-768. doi: 10.1093/europace/eux005.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation and left atrial appendage occlusion and Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion in people with Atrial Fibrillation and Left Atrial Appendage, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 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 21 May 2021. 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 Qun Shan Wang, Doctor (008613621878542, wangqunshan@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation recurrence (time frame: one year after operation). The study lists 5 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 NCT04897204, which also lists 12 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 21 May 2021.