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

Prophylactic Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure: a Prospective, Multi-center, Randomized Controlled Study

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 Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Atrial Flutter Typical
• Intervention / Treatment: Procedure: Cavo-tricuspid isthmus ablation; Procedure: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youmei Shen, M.D.; Phone Number: +86-15720801576; Email: symnjmu@163.com
• Study Contact Backup: Name: Hailei Liu, M.D.; Phone Number: +86-18094226858; Email: liuhailei@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CTI-alone arm	Procedure: Cavo-tricuspid isthmus ablation; 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.
Experimental: CTI+CPVI Arm	Procedure: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Time to cardiovascular death		From randomization until completion of the planned follow-up, assessed up to 48 months
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 urgent visits for heart failure		From randomization until completion of the planned follow-up, assessed up to 48 months
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
Time to change of diuretics		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	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.	One-year
Change in 6-minute walk test at one-year		One-year
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	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.	One-year

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: January 25, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Heart failure; atrial flutter; Pulmonary vein isolation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Flutter
• Other Study ID Numbers: 2025-SR-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No