Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Feb 5, 2025

Keywords

ClinConnect Summary

The PVI-AFL-HF Trial is a clinical study designed to explore two different treatment options for patients who have typical atrial flutter (a type of irregular heartbeat) and heart failure. The main goal of the trial is to see if a procedure called pulmonary vein isolation (CPVI), when added to a standard treatment called cavo-tricuspid isthmus (CTI) ablation, can improve long-term health outcomes compared to using CTI ablation alone.

To participate in this trial, you need to be between 18 and 80 years old and have typical atrial flutter that requires treatment. You should also have heart failure that meets specific criteria, such as a certain level of symptoms and blood test results. It's important that you have been on the right heart failure medications for at least a month and have been on blood thinners for three weeks before joining. However, if you have a history of other heart conditions or certain health issues, you may not be able to participate. If you choose to join the trial, you will be informed about what to expect during the study, and your health will be closely monitored.

Gender

ALL

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