Using a new balloon technique to treat atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation in patients with symptomatic paroxysmal atrial fibrillation. It is a prospective, single-arm First-in-Human study that includes patients who are undergoing their first pulmonary vein isolation procedure. Participants will be monitored for one year following the initial ablation to assess outcomes and safety. The study aims to provide insights into a novel ablation technique that may improve treatment for this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Recurrent symptomatic PAF with at least one documented episode
* Failure or intolerance of at least one AAD
* Age 18-75 years
* Patient is indicated for an ablation procedure according to society guidelines or study site practice
* Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study

Exclusion Criteria:

* overall good health as established by multiple criteria

Where it's running

• Na Homolce Hospital
  Prague, Czech Republic, Czechia Recruiting

Study contacts

• Study coordinator: Vikramaditya Mediratta, MS
• Email: vmediratta@cardiofocus.com
• Phone: 714-717-2376

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Renal Nerve Stimulation to Help Blood Pressure in AF and HFpEF

  This study tests whether stimulating the kidneys with a catheter can safely lower blood pressure in adults with atrial fibrillation and HFpEF who also have hypertension.

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• Biofeedback helps people with paroxysmal atrial fibrillation stay active

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• Progressive Resistance Training First to Help AF and HFpEF Patients Feel Better

  This trial tests whether starting with progressive resistance training before aerobic exercise can improve exercise capacity and quality of life in people aged 60 and older who have atrial fibrillation and HFpEF.

  Recruiting Northwestern University · Chicago, Illinois · NCT07324772

• Digital MediYoga for quality of life and heart measures in paroxysmal atrial fibrillation

  This trial will test whether a 12-week, app-delivered MediYoga program can improve disease-specific quality of life and reduce blood pressure and heart rate in adults with paroxysmal atrial fibrillation.

  Recruiting Herlev and Gentofte Hospital · Herlev · NCT07321964

• Pulsed-field pulmonary vein isolation with optional radiofrequency nerve-targeting for paroxysmal atrial fibrillation

  This trial tests whether adding selective radiofrequency ablation of a parasympathetic ganglion to pulsed-field pulmonary vein isolation helps adults with paroxysmal atrial fibrillation have fewer recurrences and fewer bradyarrhythmic events.

  Recruiting St. Joseph's Centre, Poland · Rzeszów, Podkarpackie Voivodeship · NCT07171463

• nano-second pulsed field (nsPFA) catheter ablation for paroxysmal atrial fibrillation using the CellFX system

  The study will try the CellFX nano-second pulsed field catheter to treat adults with recurrent, drug-resistant paroxysmal atrial fibrillation.

  Recruiting Pulse Biosciences, Inc. · Prague, Roentgenova · NCT07018596

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.