Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure

NCT06817447 | Not Yet Recruiting DMC

• 1 other identifier: 2025-SR-026
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

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

Keywords

atrial flutter; Heart failure; Pulmonary vein isolation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

CTI-alone arm

ACTIVE COMPARATOR

Procedure: Cavo-tricuspid isthmus ablation

CTI+CPVI Arm

EXPERIMENTAL

Procedure: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation

Interventions

Pulmonary vein isolation plus cavo-tricuspid isthmus ablation 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.

CTI+CPVI Arm

Cavo-tricuspid isthmus ablation 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-alone arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Heart Failure; Atrial Flutter

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Youmei Shen, M.D.

CONTACT

+86-15720801576; symnjmu@163.com

Hailei Liu, M.D.

CONTACT

+86-18094226858; liuhailei@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Follow-up physicians are blinded to treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 10, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 10, 2025

Record last verified: 2025-02