pulmonary hypertension
Conditions
Interventions
Transcatheter Left Atrial Appendage Closure + Transcatheter Pulmonary Artery Denervation:None
Transcatheter Left Atrial Appendage Closure:None
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 18 years and = 2 points in males or >= 3 points in females), symptomatic non-valvular persistent atrial fibrillation (AF lasting >= 7 days with ineffective or intolerable AAD therapy), and meeting at least one of the following criteria: (1) Contraindication for long-term anticoagulation; (2) Stroke or embolism occurring despite long-term standardized anticoagulation therapy; (3) Increased bleeding risk (e.g., HAS-BLED score >= 3 points) or intolerance to oral anticoagulants, including history of bleeding, fall risk, uncontrolled hypertension, renal or hepatic failure, alcohol consumption, concomitant use of antiplatelet or non-steroidal drugs, high-risk occupation, unstable international normalized ratio (INR), intolerance/allergy to oral anticoagulants, or drug interactions; (4) Patients who have undergone left atrial appendage electrical isolation (LAAEI); 3. In cases of concurrent pulmonary hypertension, the results of right heart catheterization must meet all of the following criteria: (1) Mean pulmonary artery pressure (mPAP) > 20 mmHg; (2) Pulmonary artery wedge pressure (PAWP) > 15 mmHg; 4. Absence of surgical contraindications for PADN; 5. Understanding and willingness to sign an informed consent form, authorizing the use of health and research-related information; 6. Readiness to adhere to the treatment and visit schedule specified in the protocol.
Exclusion criteria
Exclusion criteria: 1.Cardiac index (CI) <1.5 L/min/m²; 2.severe renal insufficiency (creatinine clearance [CrCL] <30 mL/min); 3.patients with severe hematologic disorders or significant bleeding tendencies (platelet count <10×10?/L; severe and extensive bleeding; suspected or confirmed intracranial hemorrhage); 4.patients with systemic inflammation, malignancies, tricuspid valve stenosis, or pulmonary artery stenosis; 5.acute systemic infectious diseases; 6.poor general condition due to various systemic illnesses; 7.venous occlusive diseases; 8.cachectic state; 9.diagnosis of WHO type 1, 3, 4, or 5 pulmonary hypertension; 10.planned other surgical or interventional procedures within 6 months; 11.life expectancy <12 months; 12.hypersensitivity to medications or metallic materials used in the study; 13.women who are breastfeeding, pregnant, or planning pregnancy within the next year; 14.participation in other clinical trials involving drugs or medical devices within 3 months prior to screening; 15.any circumstances deemed by investigators as unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six-minute walk distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in echocardiography compared to baseline;Changes from baseline in right heart catheterization findings;Changes in cardiac magnetic resonance imaging (MRI) compared to baseline;NYHA Heart Function Classification;NT-proBNP/BNP;KCCQ total points; | — |
Countries
China
Contacts
Public ContactXuan Zheng
Zhongnan Hospital of Wuhan University
Outcome results
None listed