Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure

NCT ID: NCT06817447

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2029-03-01

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.

Conditions

Atrial Flutter Typical; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CTI-alone arm

Group Type: ACTIVE_COMPARATOR

Cavo-tricuspid isthmus ablation

Intervention Type: PROCEDURE

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.

CTI+CPVI Arm

Group Type: EXPERIMENTAL

Pulmonary vein isolation plus cavo-tricuspid isthmus ablation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Minglong Chen

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Youmei Shen, M.D.

Role: CONTACT

symnjmu@163.com

+86-15720801576

Hailei Liu, M.D.

Role: CONTACT

liuhailei@njmu.edu.cn

+86-18094226858

Other Identifiers

2025-SR-026

Identifier Type: -

Identifier Source: org_study_id