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

NCT07127900 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-10-01

No results posted yet for this study

Summary

This study aims to better understand the potential side effects of a heart treatment called PFA (Pulsed Field Ablation), used to treat an arrhythmia known as atrial fibrillation. This technique has already been in clinical use for several years.

The goal of the study is to detect a possible adverse effect of this procedure: injury to the phrenic nerve, which could result in paralysis of one side of the diaphragm. The diaphragm is an important muscle for breathing and can occasionally be affected during certain cardiac ablation procedures.

To assess this, patients will undergo a dynamic chest X-ray (fluoroscopy) before and after the procedure. If diaphragm movement appears reduced afterward, a follow-up exam will be performed at 3 months to monitor the evolution. Patients presenting with a fluoroscopic abnormality at Month 3 will undergo a follow-up at Month 6. If the abnormality persists at M6, follow-up will be extended to Month 12.

The study does not involve any experimental treatment or changes to standard medical care, and there are no additional risks associated with the planned exams. It is entirely observational. All data will be used anonymously to help improve the safety of current techniques.

Conditions

  • Atrial Fibrillation (AF)
  • Phrenic Nerve-related Diaphragmatic Impairment

Sponsors & Collaborators

  • Laurent Macle

    lead OTHER

Principal Investigators

  • Laurent Macle, MD · Montreal Heart Institute - Montréal, QC

  • Frederic Franceschi, MD. Pr. · Auckland City Hospital (ACH)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-04-01
Completion
2027-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07127900 on ClinicalTrials.gov