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New treatment option for Atrial Fibrillation
Official title Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
ClinicalTrials.gov ID: NCT07462910
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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
See the full eligibility criteria
- 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 treatment 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.
- Individuals deprived of liberty by judicial or administrative decision.
- Adults subject to a legal protection measure (guardianship, curatorship, or judicial protection/safeguard of justice).
- Individuals unable to provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Canada
- Chambray-lès-Tours, France
- Lyon, France
- Pau, France
- Pessac, France
- Saint-Denis, France
- Strasbourg, France
- Toulouse, France
- Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Canada; Chambray-lès-Tours, France; Lyon, France; Pau, France; Pessac, France; Saint-Denis, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.