Pulmonary Vein Isolation in Typical Atrial Flutter and 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
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
Treatments tested in this trial
- Pulmonary vein isolation plus cavo-tricuspid isthmus ablation
- Cavo-tricuspid isthmus ablation
Treatment groups
168 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov