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The Impact of Atrial Pressure Change Before and After Combined Procedure

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ClinicalTrials.gov Identifier: NCT05106270
Recruitment Status : Recruiting
First Posted : November 3, 2021
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

Brief Summary:
One-stop procedure combining catheter ablation (CA) and left atrial appendage closure (LAAC) has been a feasible treatment for patients with atrial fibrillation at high risk of stroke and/or bleeding. Although it could achieve considerable rhythm control and stroke prophylaxis, a number of patients has experienced progressive heart failure after the procedure. Notably, previous studies indicate that both pulmonary vein isolation by CA and LAAC could significantly increase left atrial pressure, while currently no study has investigated left atrial pressure change in patients underwent combined procedure. The investigators hypothesise that combined procedure would significantly increase left atrial pressure and subsequently deteriorate cardiac function. Therefore, the investigators aim to measure the left and right atrial pressure change before and after CA and LAAC in combined procedure, and investigate the influence of the pressure change on clinical outcomes.

Condition or disease Intervention/treatment
Atrial Fibrillation Heart Failure Diagnostic Test: Atrial pressure measurement using transseptal puncture sheath

Detailed Description:
  1. 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.
  2. 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:

    1. At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3);
    2. Contraindicated to oral anticoagulation (OAC);
    3. Refused OAC treatment albeit comprehensively informed of the necessity and benefits of OAC treatment.
  3. 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.

  4. 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: 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
Actual Study Start Date : November 10, 2021
Estimated Primary Completion Date : November 10, 2023
Estimated Study Completion Date : November 10, 2027

Resource links provided by the National Library of Medicine


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.
Diagnostic Test: Atrial pressure measurement using transseptal puncture sheath
both left and right atrial pressure was measured using transseptal puncture sheath before and after combined procedure




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. Early recurrence of atrial arrhythmia [ Time Frame: From time of completion of combined procedure until the third month since the procedure ]
    Atrial tachycardia, atrial flutter, or atrial fibrillation that last for longer than 15 seconds recorded by ECG or Holter

  5. 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 ]
    Atrial tachycardia, atrial flutter, or atrial fibrillation that last for longer than 15 seconds recorded by ECG or Holter

  6. 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

  7. Change from baseline echocardiographic measurement at 3 months [ Time Frame: 3 months 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.

  8. Change from baseline echocardiographic measurement at 1 year [ Time Frame: 1 year 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.

  9. 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.

  10. 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

  11. Change from baseline quality of life evaluation at 1 year [ Time Frame: 1 year after combined procedure ]
    EQ-5D questionnaire evaluation of quality of life

  12. 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

  13. Change from baseline walking distance of 6-min walk test at 3 months [ Time Frame: 3 months after combined procedure ]
    Maximum walking distance measured from 6-min walk test

  14. Change from baseline walking distance of 6-min walk test at 1 year [ Time Frame: 1 year after combined procedure ]
    Maximum walking distance measured from 6-min walk test

  15. Change from baseline walking distance of 6-min walk test at 5 years [ Time Frame: 5 years after combined procedure ]
    Maximum walking distance measured from 6-min walk test

  16. Evaluation of left atrial appendage closure at 3 months [ Time Frame: 3 months after combined procedure ]
    Either transesophageal echocardiography or CTA evaluation of occluder position, residual flow, presence of thrombosis.


Biospecimen Retention:   Samples Without DNA
Besides routine peripheral blood sample for clinical use, intra-atrial blood sample 1-2ml are collected for biochemical analysis.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study is designed to investigate the change of atrial pressure before and after combined procedure of catheter ablation and left atrial appendage closure, and evaluate its influence on prognosis. This study aims to recruit patients diagnosed with atrial fibrillation who are eligible for combined procedure. Patients with paroxysmal, persistent, or longstanding persistent AF are included, whether it is new-onset or drug refractory.
Criteria

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:

    1. At high risk of stroke (CHA2DS2-VASc score≥3 in female, ≥2 in male) and/or bleeding (HAS-BLED score≥3);
    2. Contraindicated to oral anticoagulation (OAC);
    3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05106270


Contacts
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Contact: Dongdong Zhao +86 18917684008 zhaodd@tongji.edu.cn
Contact: Zhongyuan Ren +86 18862186450 2111714@tongji.edu.cn

Locations
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China, Shanghai
Department of Cardiology, Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Zhongyuan Ren, MD    +8618862186450    cloudyrzy@gmail.com   
Contact: Dongdong Zhao, MD, PhD       249620601@163.com   
Principal Investigator: Yawei Xu, MD, PhD         
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: Yawei Xu Shanghai 10th People's Hospital
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Responsible Party: Ya-Wei Xu, Chief physician, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT05106270    
Other Study ID Numbers: APPREANCE-AF
First Posted: November 3, 2021    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ya-Wei Xu, Shanghai 10th People's Hospital:
Left atrial pressure
combined procedure
Catheter ablation
Left atrial appendage closure
Cardiac function
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes