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NCT07462910: DEFINE-PFA

Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation

Not yet recruiting NA Last updated 10 March 2026
What this trial tests

NA trial testing Dynamic fluoroscopy in Atrial Fibrillation in 250 participants. Not yet recruiting.

Timeline
1 May 2026
Primary endpoint
31 May 2027
31 May 2027

Quick facts

Lead sponsorFrench Cardiology Society
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment250
Start date1 May 2026
Primary completion31 May 2027
Estimated completion31 May 2027
Sites9 locations across France, Canada, New Zealand

Drugs / interventions tested

Conditions studied

Sponsor

French Cardiology Society

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pulsed Field Ablation (PFA) represents a recent advance in the treatment of atrial fibrillation (AF), with a safety profile potentially superior to traditional thermal techniques, such as radiofrequency or cryoablation. Its mechanism of action allows tissue selectivity which in theory limits damage to extracardiac structures. However, several cases of right diaphragmatic paralysis have been reported in the literature after PFA, particularly during applications on the right pulmonary veins, near the right phrenic nerve. The available data are from studies without specific diaphragmatic monitoring. The diagnosis of diaphragmatic paralysis is most often based on chest X-ray, a static examination of limited sensitivity, especially for the detection of incomplete paralysis. To date, no prospective multicentre study has evaluated the incidence of diaphragmatic paralysis after PFA with systematic dynamic imaging, such as fluoroscopy, considered the gold standard for the diagnosis of unilateral paralysis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

Other French Cardiology Society trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07462910.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing