Clinical trial NCT05106270: The Impact of Atrial Pressure Change Before and After Combined Procedure
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Heart Failure
Keywords: Left atrial pressure
combined procedure
Catheter ablation
Left atrial appendage closure
Cardiac function
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Composite endpoint
timeFrame: 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 outcomes:
measure: All-cause mortality
timeFrame: From date of inclusion until the date of documented death of any reason, assessed up to 60 months
measure: Major cardiovascular adverse event
timeFrame: From date of inclusion until the date of first documented cardiovascular events mentioned above, assessed up to 60 months
measure: Rehospitalization due to cardiovascular diseases
timeFrame: From date of inclusion until the date of first documented rehospitalization due to cardiovascular diseases, assessed up to 60 months
measure: Early recurrence of atrial arrhythmia
timeFrame: From time of completion of combined procedure until the third month since the procedure
measure: Recurrence of atrial arrhythmia
timeFrame: From the third month since the procedure until the date of recurrence of atrial arrhythmia as described above, assessed up to 60 months
measure: Stoke/transient ischemic attack
timeFrame: From date of inclusion until the date of first documented stoke/transient ischemic attack, assessed up to 60 months
measure: Change from baseline echocardiographic measurement at 3 months
timeFrame: 3 months after combined procedure
measure: Change from baseline echocardiographic measurement at 1 year
timeFrame: 1 year after combined procedure
measure: Change from baseline echocardiographic measurement at 5 years
timeFrame: 5 years after combined procedure
measure: Change from baseline quality of life evaluation at 3 months
timeFrame: 3 months after combined procedure
measure: Change from baseline quality of life evaluation at 1 year
timeFrame: 1 year after combined procedure
measure: Change from baseline quality of life evaluation at 5 years
timeFrame: 5 years after combined procedure
measure: Change from baseline walking distance of 6-min walk test at 3 months
timeFrame: 3 months after combined procedure
measure: Change from baseline walking distance of 6-min walk test at 1 year
timeFrame: 1 year after combined procedure
measure: Change from baseline walking distance of 6-min walk test at 5 years
timeFrame: 5 years after combined procedure
measure: Evaluation of left atrial appendage closure at 3 months
timeFrame: 3 months after combined procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Cardiology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yawei Xu
role: PRINCIPAL_INVESTIGATOR
References: