The Impact of Atrial Pressure Change Before and After Combined Procedure

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106270
• Other study ID #: APPREANCE-AF
• Status: Recruiting
• Start date: November 10, 2021
• Est. completion date: November 10, 2027

Study information

• Verified date: August 2022
• Source: Shanghai 10th People's Hospital
• Contact: Dongdong Zhao
• Phone: +86 18917684008
• Email: zhaodd[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 10, 2027
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
China	Department of Cardiology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint	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	All-cause mortality	death of any reason	From date of inclusion until the date of documented death of any reason, assessed up to 60 months
Secondary	Major cardiovascular adverse event	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
Secondary	Rehospitalization due to cardiovascular diseases	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
Secondary	Early recurrence of atrial arrhythmia	Atrial tachycardia, atrial flutter, or atrial fibrillation that last for longer than 15 seconds recorded by ECG or Holter	From time of completion of combined procedure until the third month since the procedure
Secondary	Recurrence of atrial arrhythmia	Atrial tachycardia, atrial flutter, or atrial fibrillation that last for longer than 15 seconds recorded by ECG or Holter	From the third month since the procedure until the date of recurrence of atrial arrhythmia as described above, assessed up to 60 months
Secondary	Stoke/transient ischemic attack	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
Secondary	Change from baseline echocardiographic measurement at 3 months	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.	3 months after combined procedure
Secondary	Change from baseline echocardiographic measurement at 1 year	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
Secondary	Change from baseline echocardiographic measurement at 5 years	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.	5 years after combined procedure
Secondary	Change from baseline quality of life evaluation at 3 months	EQ-5D questionnaire evaluation of quality of life	3 months after combined procedure
Secondary	Change from baseline quality of life evaluation at 1 year	EQ-5D questionnaire evaluation of quality of life	1 year after combined procedure
Secondary	Change from baseline quality of life evaluation at 5 years	EQ-5D questionnaire evaluation of quality of life	5 years after combined procedure
Secondary	Change from baseline walking distance of 6-min walk test at 3 months	Maximum walking distance measured from 6-min walk test	3 months after combined procedure
Secondary	Change from baseline walking distance of 6-min walk test at 1 year	Maximum walking distance measured from 6-min walk test	1 year after combined procedure
Secondary	Change from baseline walking distance of 6-min walk test at 5 years	Maximum walking distance measured from 6-min walk test	5 years after combined procedure
Secondary	Evaluation of left atrial appendage closure at 3 months	Either transesophageal echocardiography or CTA evaluation of occluder position, residual flow, presence of thrombosis.	3 months after combined procedure