Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure (PVI-AFL-HF)

Nanjing Medical University

Status: Not yet enrolling

Conditions: Atrial Flutter Typical; Heart Failure

Treatments: Procedure: Cavo-tricuspid isthmus ablation; Procedure: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06817447

2025-SR-026

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 2 patient groups

CTI-alone arm

Active Comparator group

Treatment:

Procedure: Cavo-tricuspid isthmus ablation

CTI+CPVI Arm

Experimental group

Treatment:

Procedure: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation