NCT07112716Not yet recruiting
SVC-isolation in Redo-AF Ablation With Isolated PV
Superior Vena Cava Isolation With Radiofrequency Ablation in Patients With Recurrent Paroxysmal Atrial Fibrillation and Durably Isolated Pulmonary Veins: A Multicenter Study
Source: ClinicalTrials.gov · Last updated 8 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Atrial fibrillation is the most common arrhythmia in the population and is often caused by arrhythmogenic foci located in the pulmonary veins. For this reason, the first attempt in atrial fibrillation catheter ablation procedures is to isolate these structures (the procedure is called indeed "pulmonary vein isolation"), which results in abolishment of arrhythmia recurrence in up to 85% of patients at short and mid-term follow-up. However, a subset of patients experience an atrial tachyarrhytmia recurrence and a second catheter ablation procedure has to be performed. If pulmary vein isolation is proven to be durable, other arrhythmogenic foci could be implicated in arrhythmia recurrence. Among extra-pulmonary vein foci, superior vena cava has been described as the most frequently involved in atrial fibrillation initiation. Therefore, its ablation could result in improved freedom from atrial fibrillation episodes during follow-up. In the present study, we sought to evaluate the safety and effectiveness of empirical superior vena cava isolation in terms of arrhythmia-free survival in patients with paroxysmal atrial fibrillation recurrence despite durable pulmonary vein isolation.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 2 Aug 2025
- Start date
- Sept 2025
- Primary completion date
- Jul 2027
- Lead sponsor
- Centro Medico Teknon
- Diseases
- Atrial fibrillation
- NCT number
- NCT07112716
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Sept 2025 to the primary completion date, Jul 2027
- 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
- Concomitant investigation treatments.
Age
- Age \< 18 years.
Other
- Pregnancy.
- Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
- Lesions other than PVI performed during first procedure
- Persistent AF at recurrence.
- Evidence of pulmonary vein reconnection at repeat procedure.
- Any additional lesion performed beyond SVC isolation during repeat procedure (in the empirical SVC isolation group only).
Who the study is looking for
- Age \> 18 years.
- Confirmed diagnosis of recurrent paroxysmal AF
- Previous transcatheter PVI-only procedure for AF.
- Evidence of persistently isolated pulmonary veins at repeat procedure.
- Signed informed consent.
Age in the registry: 18 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 |
|---|---|---|---|
| Heart Institute, Teknon Medical Centre Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.