Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure

N/ANot Yet RecruitingNCT06817447

The First Affiliated Hospital with Nanjing Medical University168 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

168

Conditions

Atrial Flutter Typical Heart Failure

Interventions

Pulmonary vein isolation plus cavo-tricuspid isthmus ablationPROCEDURE

For those who are randomized to CTI+CPVI Arm, additional CPVI should be performed after finishing CTI ablation. CPVI could be performed using open-irrigated contact-force catheter, cryoballoon catheter or pulse-field ablation catheter. The endpoint is defined as both entrance and exit block in the pulmonary veins.

Cavo-tricuspid isthmus ablationPROCEDURE

In periprocedural period, all antiarrhythmic drugs were discontinued for at least 5 half-lives and amiodarone for 2 months before the procedure. An electrophysiological study was performed after overnight fasting and mild sedated state with administration of intravenous midazolam and fentanyl. CTI ablation should be performed under the CARTO or Ensite electroanatomic mapping system using an open-irrigated contact-force ablation catheter. Radiofrequency should be delivered at 30-50 W with a contact-force between 5-30 g in a point-by-point fashion until the CTI line is completed. Touch-up radiofrequency should be performed as needed. The endpoint of ablation is termination of AFL, if present, and the demonstration of bidirectional block across the CTI by using differential pacing.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death