Clinical trial NCT06817447: Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure
Official title: Prophylactic Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure: a Prospective, Multi-center, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Flutter Typical
Heart Failure
Keywords: atrial flutter
Heart failure
Pulmonary vein isolation
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Composite endpoint of worsening heart failure requiring unplanned hospitalizations or urgent visits, and cardiovascular death
timeFrame: From randomization until completion of the planned follow-up, assessed up to 48 months
Secondary outcomes:
measure: Time to cardiovascular death
timeFrame: From randomization until completion of the planned follow-up, assessed up to 48 months
measure: Time to hospitalization or urgent visits for heart failure
timeFrame: From randomization until completion of the planned follow-up, assessed up to 48 months
measure: Time to hospitalization for heart failure
timeFrame: From randomization until completion of the planned follow-up, assessed up to 48 months
measure: Time to urgent visits for heart failure
timeFrame: From randomization until completion of the planned follow-up, assessed up to 48 months
measure: Time to all-cause death
timeFrame: From randomization until completion of the planned follow-up, assessed up to 48 months
measure: Time to atrial fibrillation recurrence
timeFrame: From randomization until completion of the planned follow-up, assessed up to 48 months
measure: Time to change of diuretics
timeFrame: From randomization until completion of the planned follow-up, assessed up to 48 months
measure: Change in quality of life - Kansas City Cardiomyopathy Questionnaire score (KCCQ-23) at one-year
timeFrame: One-year
measure: Change in 6-minute walk test at one-year
timeFrame: One-year
measure: Change in N-terminal pro-B type natriuretic peptide (NT-proBNP) at one-year
timeFrame: One-year
measure: Change in New York Heart Association (NYHA) class at one-year
timeFrame: One-year
Other outcomes:
Locations:
Study officials:
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