Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Atrial Flutter Typical

• Registration Number: NCT06817447
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

This study, called the PVI-AFL-HF Trial, investigates two treatments for patients with typical atrial flutter (AFL) and heart failure (HF). It aims to determine whether adding prophylactic pulmonary vein isolation (CPVI) to the standard cavo-tricuspid isthmus (CTI) ablation improves long-term outcomes compared to CTI ablation alone.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-25
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-03-01
• Primary Completion: 2029-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Aged 18 to 80 years
• Typical AFL referring for ablation
• No prior history of AF
• Fulfilling the criteria for HF: New York Heart Association (NYHA) function class II or greater; and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) >125 pg/ml in sinus rhythm or >365 pg/ml in AFL
• Optimized guideline-directed medical therapy for HF for at least one month
• A minimum of anticoagulation for three weeks
• Sign informed consent

Exclusion Criteria

• Any AF episodes documented during 48-hour Holter monitoring
• Presence of left atrial thrombus
• HF due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
• Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment
• Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
• Untreated hypothyroidism or hyperthyroidism
• Dialysis-dependent terminal renal failure
• Life expectancy <12 months due to non-cardiovascular causes.
• Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
• Female under pregnancy or breast-feeding
• Involved in other studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death	From randomization until completion of the planned follow-up, assessed up to 48 months

Secondary Outcome Measures

Name	Time	Method
Time to hospitalization or urgent visits for heart failure	From randomization until completion of the planned follow-up, assessed up to 48 months
Time to hospitalization for heart failure	From randomization until completion of the planned follow-up, assessed up to 48 months
Time to change of diuretics	From randomization until completion of the planned follow-up, assessed up to 48 months
Time to urgent visits for heart failure	From randomization until completion of the planned follow-up, assessed up to 48 months
Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) at one-year	One-year
Change in New York Heart Association (NYHA) class at one-year	One-year	NYHA class is a widely used system for assessing the functional status and severity of heart failure symptoms in patients, with NYHA class IV being the worst.
Time to all-cause death	From randomization until completion of the planned follow-up, assessed up to 48 months
Time to atrial fibrillation recurrence	From randomization until completion of the planned follow-up, assessed up to 48 months
Change in quality of life - Kansas City Cardiomyopathy Questionnaire score (KCCQ-23) at one-year	One-year	KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ Total Symptom Score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Change in 6-minute walk test at one-year	One-year
Time to cardiovascular death	From randomization until completion of the planned follow-up, assessed up to 48 months