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Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation (DEFINE-PFA) 250
Clinical Trial NCT07462910 (DEFINE-PFA) is an interventional study for Atrial Fibrillation and is currently not yet recruiting. Enrollment is planned to begin on May 1, 2026 and continue until the study accrues 250 participants. Led by French Cardiology Society, this study is expected to complete by May 31, 2027. The latest data from ClinicalTrials.gov was last updated on March 10, 2026.
Brief Summary
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...Show More
Detailed Description
The current study, DEFINE-PFA, aims to include 250 patients spread over 9 centres (France, New-Zealand and Canada). Each patient will benefit from dynamic fluoroscopy before and after the procedure. A new fluoroscopy will be performed at 3 months in patients with a significant reduction (>15%) in postoperative diaphragmatic amplitude.
The primary endpoint is based on the appearance of post-procedure inter-hemi diap...
Show MoreOfficial Title
Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation Prospective Multicentre Study on the Evaluation of the Incidence of Diaphragmatic Paralysis After Pulsed Field Ablation Procedures to Treat Atrial Fibrillation
Conditions
Atrial FibrillationOther Study IDs
- DEFINE-PFA
- 2025-07
NCT ID Number
Start Date (Actual)
2026-05-01
Last Update Posted
2026-03-10
Completion Date (Estimated)
2027-05-31
Enrollment (Estimated)
250
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Pulsed Field Ablation
Fluoroscopy
Diaphragmatic monitoring
Fluoroscopy
Diaphragmatic monitoring
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalIntervention Systematic observation of an additional examination (dynamic fluoroscopy) performed before and after a Pulsed Field Ablation procedure, as part of the standard management of atrial fibrillation. | Dynamic fluoroscopy Fluoroscopic loop recording or continuous digital scopy of the thoracic window, over at least one complete breathing cycle at maximum amplitude. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Diaphragmatic paralysis | Post-procedural occurrence of diaphragmatic contraction asymmetry, defined as a ≥15% reduction in the cranio-caudal amplitude of a hemi-diaphragm, relative to the contralateral side, measured by dynamic fluoroscopy during a forced breathing cycle, and absent on pre-procedure fluoroscopy. | Day1: Before the Pulsed Field Ablation and after the Pulsed Field Ablation (at hospital discharge between 2 and 30 hours after ablation, according to a rigorously standardized protocol in all participating centres) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Rate of complete or partial recovery of diaphragmatic function at 3 months. | For patient with diaphragmatic paralysis observed at inclusion visit, diaphragmatic contraction asymmetry evaluation will be redo after 3 months. | At 3 months |
Evaluation of symptoms associated with diaphragmatic paralysis | Presence / absence of symptoms : dyspnea, discomfort on inspiration, decreased physical capacity, sleep disturbances. | Day 1, at 3 months |
Evaluation of the efficiency of the procedure | Comparison, between patients who experienced diaphragmatic paralysis after ablation and those who did not, of the duration of the procedure (in minutes), the duration of the endoscopy (in minutes), the total number of applications and the type of catheter used. | Day1 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Men and women aged 18 years or older at the time of signing the consent (age≥ 18).
- Diagnosis of paroxysmal or persistent atrial fibrillation, documented in any type of means: ECG, Holter, invasive monitoring (memories of an implantable device) or not (connected objects).
- Indication for ablation decided as part of routine care, according to the recommendations of learned societies.
- First, ablation procedure (including pulmonary vein isolation) planned with the use of a commercially available Pulsed Field Ablation catheter.
- Possibility of performing a fluoroscopic diaphragmatic evaluation before and after the operation (before discharge from the hospital).
- Free, informed and signed consent by the patient before any data collection
Known history of diaphragmatic paralysis (right or bilateral) or pre-existing clinical suspicion.
History of atrial fibrillation ablation.
History of neuromuscular disease.
History of major thoracic surgery or chronic pulmonary pathology that may impair diaphragmatic kinetics.
Evidence of diaphragmatic paralysis on the pre-procedure fluoroscopy loop, defined as:
- Cranio-caudal excursion amplitude ≤35 mm on both hemidiaphragms, Or
- An asymmetry in contraction amplitude ≥15% between the two sides.
Inability to perform a post-procedure follow-up fluoroscopy (logistical limitation, patient refusal, contraindication to irradiation).
Pregnancy or breastfeeding in progress.
Concurrent participation in another interventional study that may interfere with the objectives of this research.
Major impairment in cognitive function or inability to understand the objectives of the study or sign a valid consent.
French Cardiology Society- 🏛️Circle Safe
Study Central Contact
Contact: Tessa BERGOT, MSc, +33144907033, [email protected]
9 Study Locations in 3 Countries
Montreal Heart Institute, Montreal, QC H1T 1C8, Canada
Laurent MACLE, MD, Contact
Auckland City Hospital, Auckland, 1023, New Zealand
Nigel LEVER, MD, Contact
CHRU de Tours - Hôpital Trousseau, Chambray-lès-Tours, 37170, France
Arnaud BISSON, MD, Contact
CHU de Lyon - Hôpital Croix-Rousse, Lyon, 69004, France
Sami FAREH, MD, Contact
Centre Hospitalier de Pau - Hôpital François Mitterrand, Pau, 64046, France
Hugues BADER, MD, Contact
CHU de Bordeaux - Hôpital Haut-Lévêque, Pessac, 33604, France
Romain TIXIER, MD, Contact
Centre Cardiologique du Nord, Saint-Denis, 93200, France
William ESCANDE, MD, Contact
Institut Cardiovasculaire de Strasbourg - Clinique Rhéna, Strasbourg, 67000, France
Babé BAKOUBOULA, MD, Contact
Clinique Pasteur, Toulouse, 31300, France
Serge BOVEDA, MD, Contact