- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05106270
The Impact of Atrial Pressure Change Before and After Combined Procedure
The Impact of Atrial Pressure Change Before and After One-stop Procedure Combining Catheter Ablation and Left Atrial Appendage Closure on the Prognosis of Patients With Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Study aim. This study was designed to measure the left and right atrial pressure change before and after catheter ablation (CA) and left atrial appendage closure (LAAC) combining procedure, and investigate the influence of the pressure change on clinical outcomes.
Subject selection. This study is designed to recruit patients diagnosed with atrial fibrillation and planned to undergo combined procedure. Primary inclusion criteria are:
i. Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months; ii. Eligible for left atrial appendage closure, that meet at least one of the followings:
- At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3);
- Contraindicated to oral anticoagulation (OAC);
- Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment.
Procedure detail. All the patients recruited is planned to undergo combined procedure. CA is performed before LAAC. For CA, the energy source is optional (either radiofrequency or cryoenergy). And ablation should be performed for pulmonary vein isolation only. For LAAC, the occluder type is optional (either plug or pacifier occluder), and intracardiac echocardiography or transesophageal echocardiography (TEE) is optional.
For atrial pressure measurement, right atrial pressure should be measured before transseptal puncture and after combined procedure is accomplished. Left atrial pressure should be measured at 3 timepoints: after transseptal puncture, after pulmonary vein isolation and after LAAC. Atrial pressure is measured via Swartz transseptal puncture sheath. And at each timepoint, atrial pressure should be recorded at 1min, 3min, and 5min after the placement of the sheath.
- Follow-up. study endpoint includes a primary composite endpoint of rehospitalization due to heart failure and death due to cardiovascular disease, and secondary endpoints including: 1. all-cause mortality 2. major cardiovascular adverse event 3. rehospitalization due to cardiovascular diseases 4. recurrence of atrial arrhythmia 5. stoke/transient ischemic attack 6. echocardiographic measurement 7. quality of life evaluation 8. cardiac function evaluation 9. evaluation of left atrial appendage closure. Patients are required to have outpatient follow-up at 3rd month, 12th month, and every year since then. The anti-thromboembolic regimen should follow: 3-month OAC treatment and 3-month double anti-platelet therapy and lifelong single anti-platelet therapy. For LAAC follow-up, either TEE or CTA is scheduled to perform in the 3rd month after procedure.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Dongdong Zhao
- Phone Number: +86 18917684008
- Email: zhaodd@tongji.edu.cn
Study Contact Backup
- Name: Zhongyuan Ren
- Phone Number: +86 18862186450
- Email: 2111714@tongji.edu.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200072
- Recruiting
- Department of Cardiology, Shanghai Tenth People's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Atrial fibrillation recorded by 12-lead ECG or Holter that last for longer than 30 seconds within the preceding 6 months;
Eligible for left atrial appendage closure, that meet at least one of the followings:
- At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3);
- Contraindicated to oral anticoagulation (OAC);
- Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment.
- Capable of understanding and signing the informed consent form.
- Aged over 18 years.
Exclusion Criteria:
- Reversible causes of atrial fibrillation, including thyroid disorders, recent major surgery, trauma, acute alcoholic intoxication;
- Concomitant arrhythmia including atrial flutter, ventricular tachycardia;
- A previous history of atrial fibrillation surgery (MAZE surgery) or catheter ablation;
- A previous history of cardiac surgery including any valvular replacement, septal repair;
- A recent history of major cardiovascular disease within 3 months, including acute myocardial infarction, ventricular fibrillation;
- A history of congenital heart disease;
- A previous history of atrioventricular node ablation;
- A history of lobectomy due to any medical condition;
- Complicated by other diseases with life expectation <1 year;
- Women with childbearing potential;
- Participated in other interventional clinical trials that might affect prognosis;
- Unable to understand or give informed consent form.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Combined procedure
The whole cohort underwent combining procedure of catheter ablation and left atrial appendage closure, atrial pressure was measured before and after pulmonary vein isolation, and after left atrial appendage closure.
|
both left and right atrial pressure was measured using transseptal puncture sheath before and after combined procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite endpoint
Time Frame: From date of inclusion until the date of first documented rehospitalization due to heart failure or date of death due to cardiovascular disease, whichever came first, assessed up to 60 months
|
Rehospitalization due to heart failure and death due to cardiovascular disease
|
From date of inclusion until the date of first documented rehospitalization due to heart failure or date of death due to cardiovascular disease, whichever came first, assessed up to 60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: From date of inclusion until the date of documented death of any reason, assessed up to 60 months
|
death of any reason
|
From date of inclusion until the date of documented death of any reason, assessed up to 60 months
|
Major cardiovascular adverse event
Time Frame: From date of inclusion until the date of first documented cardiovascular events mentioned above, assessed up to 60 months
|
cardiovascular events including myocardial infarction, malignant arrhythmia, acute heart failure, cardiac tamponade.
|
From date of inclusion until the date of first documented cardiovascular events mentioned above, assessed up to 60 months
|
Rehospitalization due to cardiovascular diseases
Time Frame: From date of inclusion until the date of first documented rehospitalization due to cardiovascular diseases, assessed up to 60 months
|
Rehospitalization due to any cardiovascular diseases
|
From date of inclusion until the date of first documented rehospitalization due to cardiovascular diseases, assessed up to 60 months
|
Early recurrence of atrial arrhythmia
Time Frame: From time of completion of combined procedure until the third month since the procedure
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Atrial tachycardia, atrial flutter, or atrial fibrillation that last for longer than 15 seconds recorded by ECG or Holter
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From time of completion of combined procedure until the third month since the procedure
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Recurrence of atrial arrhythmia
Time Frame: From the third month since the procedure until the date of recurrence of atrial arrhythmia as described above, assessed up to 60 months
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Atrial tachycardia, atrial flutter, or atrial fibrillation that last for longer than 15 seconds recorded by ECG or Holter
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From the third month since the procedure until the date of recurrence of atrial arrhythmia as described above, assessed up to 60 months
|
Stoke/transient ischemic attack
Time Frame: From date of inclusion until the date of first documented stoke/transient ischemic attack, assessed up to 60 months
|
Cerebral infarction, intracranial hemorrhage, or transient ischemic attack confirmed by CT/MRI
|
From date of inclusion until the date of first documented stoke/transient ischemic attack, assessed up to 60 months
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Change from baseline echocardiographic measurement at 3 months
Time Frame: 3 months after combined procedure
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Echocardiographic measured left atrial parameters including left atrial volume, left atrial volume index, e, e' and left ventricle parameters including left ventricular ejection fraction, left ventricle systolic and diastolic diameter.
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3 months after combined procedure
|
Change from baseline echocardiographic measurement at 1 year
Time Frame: 1 year after combined procedure
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Echocardiographic measured left atrial parameters including left atrial volume, left atrial volume index, e, e' and left ventricle parameters including left ventricular ejection fraction, left ventricle systolic and diastolic diameter.
|
1 year after combined procedure
|
Change from baseline echocardiographic measurement at 5 years
Time Frame: 5 years after combined procedure
|
Echocardiographic measured left atrial parameters including left atrial volume, left atrial volume index, e, e' and left ventricle parameters including left ventricular ejection fraction, left ventricle systolic and diastolic diameter.
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5 years after combined procedure
|
Change from baseline quality of life evaluation at 3 months
Time Frame: 3 months after combined procedure
|
EQ-5D questionnaire evaluation of quality of life
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3 months after combined procedure
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Change from baseline quality of life evaluation at 1 year
Time Frame: 1 year after combined procedure
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EQ-5D questionnaire evaluation of quality of life
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1 year after combined procedure
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Change from baseline quality of life evaluation at 5 years
Time Frame: 5 years after combined procedure
|
EQ-5D questionnaire evaluation of quality of life
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5 years after combined procedure
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Change from baseline walking distance of 6-min walk test at 3 months
Time Frame: 3 months after combined procedure
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Maximum walking distance measured from 6-min walk test
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3 months after combined procedure
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Change from baseline walking distance of 6-min walk test at 1 year
Time Frame: 1 year after combined procedure
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Maximum walking distance measured from 6-min walk test
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1 year after combined procedure
|
Change from baseline walking distance of 6-min walk test at 5 years
Time Frame: 5 years after combined procedure
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Maximum walking distance measured from 6-min walk test
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5 years after combined procedure
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Evaluation of left atrial appendage closure at 3 months
Time Frame: 3 months after combined procedure
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Either transesophageal echocardiography or CTA evaluation of occluder position, residual flow, presence of thrombosis.
|
3 months after combined procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yawei Xu, Shanghai 10th People's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APPREANCE-AF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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