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

NCT07127900 | Withdrawn

• 1 other identifier: ICM-2026-3595
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Presence or absence of diaphragmatic abnormality

  asymmetry ≥ 15%, paradoxical excursion

  Hospital discharge

Secondary Outcomes (3)

• Respiratory symptoms associated with diaphragmatic paralysis

  Hospital discharge: up to 48hrs post-procedure

• Correlation between technical characteristics of the ablation and the occurrence of diaphragmatic paralysis.

  Hospital discharge: up to 48hrs post-procedure

• Final status of the recovery of diaphragmatic abnormalities

  12 months post-procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study plans to include 250 consecutive patients undergoing atrial fibrillation ablation by PFA, regardless of the "one-shot" system used (FARAPULSE™, PULSE SELECT™, VARIPULSE™, or VOLT™), at the discretion of each operator.

You may qualify if:

• Diagnosis of paroxysmal or persistent atrial fibrillation (AF), documented by any method: ECG, Holter, invasive monitoring (implantable device memory), or non-invasive monitoring (connected devices).
• Ablation indication decided as part of routine care, according to society guidelines.
• First ablation procedure (including pulmonary vein isolation) planned using a commercially available PFA catheter.
• Ability to perform diaphragmatic fluoroscopic evaluation before and after the procedure (before hospital discharge).

You may not qualify if:

• Patients presenting with one or more of the following conditions will be excluded from the study:
• Known history of diaphragmatic paralysis (right-sided or bilateral) or preexisting clinical suspicion.
• History of atrial fibrillation ablation.
• History of neuromuscular disease.
• History of major thoracic surgery or chronic pulmonary pathology likely to impair diaphragmatic motion.
• Diaphragmatic paralysis diagnosed during the pre-procedure fluoroscopic assessment.
• Inability to perform post-procedure fluoroscopic control (due to logistical limitations, patient refusal, or contraindication to radiation exposure).
• Current pregnancy or breastfeeding.
• Concurrent participation in another interventional study that may interfere with the objectives of the present research.
• Significant cognitive impairment or inability to understand the study objectives or provide valid consent.

Sponsors & Collaborators

• Laurent Macle: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent Macle, MD

  Montreal Heart Institute - Montréal, QC

  PRINCIPAL INVESTIGATOR

• Frederic Franceschi, MD. Pr.

  Auckland City Hospital (ACH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiologist electrophysiologist

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 17, 2025
• Study Start: October 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share