Dynamic Fluoroscopy for Atrial Fibrillation

(DEFINE-PFA Trial)

Not yet recruiting at 8 trial locations

Overseen By Tessa BERGOT, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: French Cardiology Society

Disqualifiers: Diaphragmatic paralysis, Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for atrial fibrillation (AF), a heart condition that causes irregular heartbeats, using Pulsed Field Ablation (PFA). PFA may be safer than traditional methods because it targets specific heart tissues, though it has been linked to diaphragm issues. The trial employs dynamic fluoroscopy, an advanced form of X-ray, to better detect diaphragm problems. Individuals diagnosed with atrial fibrillation and scheduled for their first ablation procedure might be suitable candidates for this study. As an unphased trial, this study offers the chance to contribute to innovative research that could enhance future AF treatments.

What prior data suggests that dynamic fluoroscopy is safe for diagnosing diaphragmatic paralysis?

Research has shown that pulsed field ablation (PFA) for treating atrial fibrillation is generally safe, with a low rate of major complications. One study found that only 1.9% of patients experienced significant safety issues, indicating that PFA is often well-tolerated. However, reports have noted a nerve issue affecting breathing, known as right diaphragmatic paralysis, after PFA. These cases mostly occurred when working near the right pulmonary veins, close to the phrenic nerve.

The imaging technique used in this study, dynamic fluoroscopy, does not directly affect patient safety. It serves as a tool to better monitor and identify potential complications, such as diaphragmatic paralysis, during PFA procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using dynamic fluoroscopy in the management of atrial fibrillation because it offers a new way to closely observe the heart's structures during and after procedures like Pulsed Field Ablation. Unlike traditional imaging techniques, dynamic fluoroscopy provides real-time, detailed visuals, which can help doctors ensure the ablation is effectively targeting the problematic areas. This approach could potentially improve the accuracy and success rate of the treatment, offering a more precise way to manage atrial fibrillation.

What evidence suggests that dynamic fluoroscopy is effective for diagnosing diaphragmatic paralysis after PFA?

Research has shown that pulsed field ablation (PFA) effectively treats atrial fibrillation (AF). In studies, doctors completely isolated the pulmonary veins in all cases, a crucial step in stopping AF. After 12 months, about 87.7% of patients maintained normal heart rhythms without irregular heartbeats. Although PFA is generally safe, some cases of right diaphragmatic paralysis have occurred. This trial uses dynamic fluoroscopy, a type of moving X-ray, to better detect this issue before and after the PFA procedure. Overall, PFA appears to be a promising treatment with a strong record of success. ^{2 3 4 6 7}

Who Is on the Research Team?

Romain TIXIER, MD

Principal Investigator

University Hospital, Bordeaux

Frédéric FRANCESCHI, MD

Principal Investigator

CHU Marseille

Are You a Good Fit for This Trial?

Inclusion Criteria

* 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.

* Free, informed and signed consent by the patient before any data collection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure Evaluation

Dynamic fluoroscopy is performed to check the absence of basic diaphragmatic asymmetry before the Pulsed Field Ablation procedure

1 day

1 visit (in-person)

Treatment

Pulsed Field Ablation procedure is performed with systematic observation using dynamic fluoroscopy

1 day

1 visit (in-person)

Post-procedure Evaluation

Dynamic fluoroscopy is performed after the procedure to assess diaphragmatic contraction asymmetry

2-30 hours after ablation

1 visit (in-person)

Follow-up

Evaluation of diaphragmatic function and symptoms associated with diaphragmatic paralysis at 3 months

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dynamic fluoroscopy

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

French Cardiology Society

Lead Sponsor

Trials

82

Recruited

66,400+

IHU Lyric

Collaborator

Circle Safe

Collaborator

ADIMEP

Collaborator

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12476173/

Clinical Outcomes of Ablation for Persistent Atrial Fibrillation ...

Safety and effectiveness were not compromised, as evidenced by a procedure-related complication rate of 2% and 12-month single procedure success ...

2.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/pace.70273

Fluoroscopy‐Free Pulsed Field Ablation for Atrial Fibrillation

Acute PVI was achieved in 100% of cases in all studies reporting this endpoint. Among cohorts with follow-up, freedom from AF ranged from 72.1% ...

3.

internationaljournalofcardiology.com

internationaljournalofcardiology.com/article/S0167-5273(25)00178-0/fulltext

12-month outcomes of pulsed-field ablation with a variable- ...

At 12 months, 87.7 % (95 % CI: 82.5 %–92.9 %) of patients remained free from atrial arrhythmia after the blanking period. No significant ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07462910

Diaphragmatic Evaluation by Fluoroscopy to Identify ...

Systematic observation of an additional examination (dynamic fluoroscopy) performed before and after a Pulsed Field Ablation procedure, as part ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33778447/

Outcomes and Safety of Fluoroless Catheter Ablation for ...

Acute procedural success (95.5% vs 98.6%, P = 0.1), complication rates (4.5% vs 2.0%, P = 0.24), and 1-year AF recurrence rates (28.7% vs 27.1%, log-rank P = ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7984996/

Outcomes and Safety of Fluoroless Catheter Ablation for Atrial ...

Acute procedural success (95.5% vs 98.6%, P = 0.1), complication rates (4.5% vs 2.0%, P = 0.24), and 1-year AF recurrence rates (28.7% vs 27.1%, log-rank P = ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05242250

Real-World Evidence Registry to Assess Outcomes of ...

The primary purpose of this registry is to assess procedural efficiencies as well as long term procedural safety and effectiveness of RF ablation in the ...