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Radiofrequency ablation based atrial septostomy in HFpEF patients: a novel device and first in man study

Radiofrequency ablation based atrial septostomy in HFpEF patients: a novel device and first in man study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027664
Enrollment
Unknown
Registered
2019-11-23
Start date
2018-11-01
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HFpEF

Interventions

Case series:Radiofrequency ablation based atrial septostomy

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Eligible patients were diagnosed of heart failure with preserved ejection fraction (HFpEF) with or without a history of cardiomyopathy; 2) Eligible patients(>=40 years of age) with New York Heart Association (NYHA) class II-IV; 3) N-terminal prohormone B-type natriuretic peptide (NT-proBNP) were more than 200 pg/mL in normal sinus rhythm or more than 600 pg/mL in atrial fibrillation; 4) Patients provided written informed consent to participate in the trial.

Exclusion criteria

Exclusion criteria: 1) Patients with severe right ventricular dysfunction, including a central venous pressure> 20 mm Hg, RAD>45mm or tricuspid annular plane systolic excursion below 14 mm; 2) Patients with pulmonary artery systolic pressure> 60mmHg estimated by transthoracic ultrasound, severe tricuspid regurgitation or with moderate/ severe mitral regurgitation; 3) Patients with moderate or severe liver and kidney dysfunction (alanine aminotransferase > 150 IU/L, and/or serum creatinine > 150 mmol/L); 4) Patients with myocardial infarction, unstable angina pectoris or cerebrovascular accident in the past 6 months; 5) Patients with congenital heart disease; 6) Patients had persistent atrial fibrillation without anticoagulation and/or suspected thrombus in the heart chamber; 7) Patients with valvular heart disease with surgical indications; 8) Patients with II/III heart block without pacemaker implantation; 9) Patients with abnormal coagulation function couldn't tolerate heparinization; 10) Patients with untreated cancer; 11) Pregnant women, in lactation or preparing to conceive; 12) Patients with active peptic ulcer or upper gastrointestinal bleeding within 3 months; 13) Patients with known allergy or contraindication to aspirin, heparin, clopidogrel, metal nitinol, or allergy to contrast medium that precludes appropriate preoperative medication; 14) Patients were also participating in other drug or device studies; 15) Patients with active infective endocarditis or other active infection; 16) Patients were unwilling to sign the informed consent; 17) Patients couldn't insist on complete follow-up.

Design outcomes

Primary

MeasureTime frame
Left atrial CT;Transthoracic echocardiography (TTE);Transesophageal echocardiography (TEE);Intracardiac echocardiography;Right heart catheterization;hepatic and renal function;

Secondary

MeasureTime frame
Plasma NT-proBNP level;6 minutes walking distance;Cardiopulmonary exercise testing;

Countries

China

Contacts

Public ContactXiangqing Kong

The First Affiliated Hospital of Nanjing Medical University

kongxq@njmu.edu.cn+86 13951610265

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026