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Efficacy of low-voltage guided biatrial ablation versus pharmacologic intervention for atrial fibrillation with chronic obstructive pulmonary disease: a prospective, multicenter, randomized controlled trial

Efficacy of low-voltage guided biatrial ablation versus pharmacologic intervention for atrial fibrillation with chronic obstructive pulmonary disease: a prospective, multicenter, randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084868
Enrollment
Unknown
Registered
2024-05-27
Start date
2024-01-04
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

atrial fibrillation

Interventions

Control group:AADs+anticoagulation+Anti-COPD therapy
Test group:CPVI (circumflex pulmonary vein electrical isolation) + biventricular low-pressure zone modification in sinus rhythm + anticoagulation + anti-COPD therapy

Sponsors

Affiliated Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: - Patients aged 40-80 years -Patients with atrial fibrillation documented by ECG or Holter who have not received catheter ablation for atrial fibrillation. - Patients with COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Diagnostic Criteria 2021 (GOLD 90% in the four weeks prior to enrollment. - Agree to participate in the study and cooperate with the perioperative and follow-up requirements; patients sign an informed consent form for the study; and have good clinical compliance to fulfill the protocol requirements and follow-up requirements.

Exclusion criteria

Exclusion criteria: - Prior treatment of atrial fibrillation with class I or III antiarrhythmic drugs, but the use of such drugs is allowed for less than 7 days in an attempt to reset the sinus rhythm of atrial fibrillation. -Presence of or potential for permanent pacemaker implantation within 12 months, with indications for pacemaker installation being severe bradycardia/atrioventricular block, myocardial contraction disorders, and arrhythmias. -Patients with contraindications to systemic anticoagulation with heparin or coumarin or direct thrombin inhibitors. - patients with left ear thromboembolism -Patients with LVEF <40%. - Patients with left atrial size = 55 mm (2D echocardiogram, parasternal long-axis view). -Patients with severe mitral regurgitation -Patients with allergy to contrast or iodine. - Patients with a history of previous cardiac surgery - Patients with reversible causes of atrial fibrillation (e.g., hyperthyroidism or alcoholism). -Patients with a life expectancy of <12 months, as measured by the patient's overall level of fitness, and who have a poor quality of life. - Patients who are pregnant or breastfeeding -Patients with a first diagnosis of asthma or COPD overlap syndrome. - Patients with a first diagnosis of asthma or COPD overlap syndrome - Patients with alpha-1 antitrypsin deficiency as a cause of COPD - History of previous lung reduction surgery -In the opinion of the treating physician, there is a high likelihood that the potential participant will not adhere to the requirements of the study.

Design outcomes

Primary

MeasureTime frame
Revisit rate for atrial arrhythmia or acute exacerbation of COPD within 1 year;

Secondary

MeasureTime frame
Rhythmic outcomes, AF load (determined by 7-day ambulatory electrocardiogram monitor), echocardiography: pulmonary artery pressure (PAP), RA/RV/LA/LV size, LVEF measured by echocardiography at 3, 6, 9, and 12 months, use of the KCCQ (Heart Failure), the AFEQT (AF), the CAT (COPD Assessment Test), and St. George's Respiratory Questionnaire (SGRQ), the 3,6,12-month CPET and 6-minute walk test to assess exercise capacity, 1-year all-cause-free death, safety endpoints, medication use for COPD and AF;

Countries

China

Contacts

Public ContactWei Li

Affiliated Hospital of Guizhou Medical University

Liwei249188@sina.com+86 138 0948 2491

Outcome results

None listed

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