EligibleTrials

Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure

Recruiting · NCT05264831 · Interventional (participants receive a specific treatment) · Lead sponsor: Elsan

View the official record on ClinicalTrials.gov →
Heart failureAtrial fibrillation

Interventions studied

PVI procedure associated with substrate modulationPulmonary Vein Isolation (PVI) alone

What this trial is about

This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation. All included patients will undergo an electric cardioversion, then: * Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients. * Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures: * PVI procedure alone * PVI procedure combined with substrate modulation

Who can take part

Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Exclusion criteria

Where it is running

13 locations listed.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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