Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure

ConditionsAtrial Flutter Typical Heart Failure

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Pulmonary vein isolation plus cavo-tricuspid isthmus ablation
Procedure/Surgery
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 ablation
Procedure/Surgery
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.

Treatment groups

168 Participants

are divided into 2 treatment groups

Group A: CTI-alone armActive comparator 1 intervention

Group B: CTI+CPVI ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame