Not yet recruiting NCT06817447
Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulmonary vein isolation plus cavo-tricuspid isthmus ablation, Cavo-tricuspid isthmus ablation.
- Who it may be relevant to
- Registry conditions: Atrial Flutter Typical, Heart Failure. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prophylactic Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure: a Prospective, Multi-center, Randomized Controlled Study
Overview
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.
Interventions
- Procedure 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. - 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 cont
Primary outcome measures
- Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death [Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months]
Secondary outcome measures (11)
- Time to cardiovascular death [Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months]
- Time to hospitalization or urgent visits for heart failure [Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months]
- Time to hospitalization for heart failure [Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months]
- Time to urgent visits for heart failure [Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months]
- Time to all-cause death [Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months]
- Time to atrial fibrillation recurrence [Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months]
- Time to change of diuretics [Time frame: From randomization until completion of the planned follow-up, assessed up to 48 months]
- Change in quality of life - Kansas City Cardiomyopathy Questionnaire score (KCCQ-23) at one-year [Time frame: One-year]
- Change in 6-minute walk test at one-year [Time frame: One-year]
- Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) at one-year [Time frame: One-year]
- Change in New York Heart Association (NYHA) class at one-year [Time frame: One-year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06817447 · 2025-SR-026