The Impact of Atrial Pressure Change Before and After Combined Procedure

NCT05106270 | Recruiting DMC

• 1 other identifier: APPREANCE-AF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

Left atrial pressure; combined procedure; Catheter ablation; Left atrial appendage closure; Cardiac function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• All-cause mortality

  From date of inclusion until the date of documented death of any reason, assessed up to 60 months

• Major cardiovascular adverse event

  From date of inclusion until the date of first documented cardiovascular events mentioned above, assessed up to 60 months

• Rehospitalization due to 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

  From time of completion of combined procedure until the third month since the procedure

• Recurrence of atrial arrhythmia

  From the third month since the procedure until the date of recurrence of atrial arrhythmia as described above, assessed up to 60 months

Study Arms (1)

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

Interventions

Atrial pressure measurement using transseptal puncture sheath DIAGNOSTIC_TEST

both left and right atrial pressure was measured using transseptal puncture sheath before and after combined procedure

Combined procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Besides routine peripheral blood sample for clinical use, intra-atrial blood sample 1-2ml are collected for biochemical analysis.

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yawei Xu

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongdong Zhao

CONTACT

+86 18917684008; zhaodd@tongji.edu.cn

Zhongyuan Ren

CONTACT

+86 18862186450; 2111714@tongji.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: November 3, 2021
• Study Start: November 10, 2021
• Primary Completion: November 10, 2023
• Study Completion (Estimated): November 10, 2027
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

CN (1)