The Effectiveness and Safety of His Purkinje Conduction System Pacing Compared with Radiofrequency Ablation and Drug in the Treatment of Atrial Fibrillation with Heart Failure

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100042446

Enrollment

Unknown

Registered

2021-01-21

Start date

2021-06-01

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Heart failure, atrial fibrillation

Interventions

the group of His Purkinje conduction system pacing therapy:His Purkinje conduction system pacing therapy

the group of radiofrequency ablation therapy: radiofrequency ablation therapy

the group of drug therapy:drug therapy

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Aged >= 18 years; (2) Have symptoms or signs of heart failure; (3) The echocardiogram indicates that the diameter of the left atrium is >= 35mm; (4) NT-proBNP value: >450pg/mL patients 900pg/mL patient 50-75 years old; >1800pg/mL patient > 75 years old. (5) Diagnosed as persistent atrial fibrillation or paroxysmal atrial fibrillation by ordinary ECG and Holter; (6) All patients and their families have informed consentd.

Exclusion criteria

Exclusion criteria: (1) Pregnant and lactating patients; (2) Severe heart valve disease, congenital heart disease, hyperthyroidism; (3) Contrast agent allergy; (4) Severe liver disease: liver function transaminase index > 3 times the normal value; (5) Severe kidney disease: renal function index GFR < 30ml/min; (6) Severe respiratory diseases: bronchial asthma, pulmonary heart disease, severe pneumonia; (7) Blood system diseases and white blood cell count < 4.0 x 10^9/L, platelet count < 100 x 100^9/L; (8) Advanced tumor; (9) Test drug contraindications and allergies; (10) Anticoagulation contraindications such as cerebral hemorrhage, hemorrhagic cerebral infarction, active ulcer, after surgery, pregnancy and childbirth, postpartum, coagulation dysfunction, etc. (11) Participated in other clinical trials in the past 3 months; (12) No legal capacity or limited legal capacity; (13) Any other situation that the investigator considers inappropriate to participate in the trial.

Design outcomes

Primary

Measure	Time frame
The Kansas city cardiomyopathy questionnaire;NT-proBNP;	—

Secondary

Measure	Time frame
death;recurrence of atrial fibrillation;ejection fraction;6-minute walk test;success rate of His Purkinje conduction system pacing therapy;success rate of radiofrequency ablation therapy;readmission rate;	—

Countries

China

Contacts

Public ContactZhijun Sun

Shengjing Hospital of China Medical University

18940251218@163.com+86 18940251218

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026