NCT06817447Not yet recruiting
Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure
Prophylactic Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure: a Prospective, Multi-center, Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 10 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 25 Jan 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 1 Mar 2029
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Heart failure
- NCT number
- NCT06817447
What you commit to
- Study type: Interventional
- Planned participants: 168
- From 1 Mar 2025 to the primary completion date, 1 Mar 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- HF due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
- Dialysis-dependent terminal renal failure
- Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
Other
- Any AF episodes documented during 48-hour Holter monitoring
- Presence of left atrial thrombus
- Untreated hypothyroidism or hyperthyroidism
- Life expectancy \<12 months due to non-cardiovascular causes.
- Female under pregnancy or breast-feeding
- Involved in other studies
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.