NCT07197931Not yet recruiting
EXPORT Randomized Trial
Comparison of Circumferential Pulmonary Vein (PV) Isolation Alone Versus Additional EXtra-PulmOnaRy Vein Trigger Ablation in Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 30 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Pulmonary Vein Isolation (PVI)-Only Group 1. Pulmonary vein isolation (PVI) will be performed, and the procedure will be terminated without the administration of isoproterenol following the standard waiting period. 2. In cases where spontaneous triggers are observed following PVI, mapping and ablation of the identified triggers are permitted. 3. Post-procedural rhythm monitoring and follow-up will be conducted in accordance with the predefined study protocol. Additional Non-Pulmonary Vein (Non-PV) Trigger Ablation Group Isoproterenol will be administered starting at 5 μg/min, with stepwise increases to 10 μg/min and 20 μg/min at 3-5 minute intervals, as tolerated, aiming to achieve 85% of the maximum predicted heart rate, with a maximum dose of 30 μg/min.The total infusion duration will be at least 10 minutes. * If systolic blood pressure (SBP) decreases by ≥20 mmHg from the baseline (prior to infusion), the isoproterenol infusion will be discontinued. * If hypotension is anticipated or occurs during isoproterenol infusion, phenylephrine infusion may be administered to maintain SBP between 120-140 mmHg. * For patients with a history of coronary artery disease, heart failure, or valvular heart disease, the maximum isoproterenol infusion rate may be limited to ≤10 μg/min at the discretion of the operator.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 406 (estimated)
- First submitted
- 26 Sept 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- Yonsei University
- Diseases
- Atrial fibrillation
- NCT number
- NCT07197931
What you commit to
- Study type: Interventional
- Planned participants: 406
- From 1 Oct 2025 to the primary completion date, 31 Aug 2029
- 1 site in 1 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
- History of prior maze surgery or catheter ablation for atrial fibrillation.
- Contraindications to anticoagulation therapy or rhythm control treatment.
- Drug or alcohol abuse.
Other illness
- Acute coronary syndrome within the past 3 months.
- Severe unrevascularized coronary artery disease: ≥70% stenosis in at least one major epicardial vessel with a diameter ≥2 mm.
- History of stroke or transient ischemic attack (TIA) within the past 3 months.
- Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥120 mmHg).
- Symptomatic moderate-to-severe valvular heart disease.
- Severe pulmonary hypertension (resting RVSP \>60 mmHg).
- Presence of cyanotic congenital heart disease.
- Active internal bleeding.
- Presence of severe comorbid conditions or life expectancy \<1 year.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
Lab values
- Heart failure with reduced ejection fraction (LVEF \<40%).
Other
- Severe untreated aortic valve stenosis.
- Aortic dissection.
- Left atrial anteroposterior diameter \>60 mm.
- Obstructive hypertrophic cardiomyopathy (resting or provoked LVOT pressure gradient ≥30 mmHg).
- Pregnancy.
Who the study is looking for
- Patients aged ≥19 years with persistent atrial fibrillation scheduled for catheter ablation.
- Refractory to or intolerant of at least one Class I or III antiarrhythmic drug.
- Undergoing first-time catheter ablation for atrial fibrillation.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance Cardiovascular Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.