Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation (NCT07462910)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Montreal Heart Institute — Montreal
Age range: 18 Years
🧪 Interventions in This Study
- Dynamic fluoroscopy (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- Montreal Heart Institute — Montreal,
- CHRU de Tours - Hôpital Trousseau — Chambray-lès-Tours,
- CHU de Lyon - Hôpital Croix-Rousse — Lyon,
- Centre Hospitalier de Pau - Hôpital François Mitterrand — Pau,
- CHU de Bordeaux - Hôpital Haut-Lévêque — Pessac,
- Centre Cardiologique du Nord — Saint-Denis,
- Institut Cardiovasculaire de Strasbourg - Clinique Rhéna — Strasbourg,
- Clinique Pasteur — Toulouse,
- Auckland City Hospital — Auckland,
📞 Contact the Study Coordinator
Phone: +33144907033
Email: tessa.bergot@sfcardio.fr
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Atrial Fibrillation
- CHAMPION-AF Clinical Trial — Birmingham, Alabama
- Reversal of Atrial Substrate to Prevent Atrial — Calgary, Alberta
- Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients — Rochester, New York
- REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry — Chandler, Arizona
- Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF) — Cleveland, Ohio
- Liraglutide Effect in Atrial Fibrillation — Miami, Florida
Explore by condition: All Atrial Fibrillation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.