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New treatment option for Paroxysmal AF
Official title BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
ClinicalTrials.gov ID: NCT07181590
What this study is testing
- What it's testing
- This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.
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
- Documented symptomatic PAF or PersAF. Documentation requirements are as follows: Paroxysmal:
- Physician's note indicating recurrent self-terminating AF AND
- One electrocardiographically documented PAF episode within 12 months prior to enrollment. Persistent: Continuous AF sustained beyond 7 days and less...
- Physician's note, AND either
- 24-hour Holter within 360 days prior to enrollment, showing continuous AF, OR
You likely can't join if
- Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and...
- Known presence of cardiac thrombus
- Known Left ventricular ejection fraction \< 35% as assessed with echocardiography within 360 days of index procedure
- New York Heart Association (NYHA) class III or IV heart failure
- Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
- Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure
See the full eligibility criteria
Who can join
- Documented symptomatic PAF or PersAF. Documentation requirements are as follows: Paroxysmal:
- Physician's note indicating recurrent self-terminating AF AND
- One electrocardiographically documented PAF episode within 12 months prior to enrollment. Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
- Physician's note, AND either
- 24-hour Holter within 360 days prior to enrollment, showing continuous AF, OR
- Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
- That are taken at least 7 days apart but less than 12 months apart
- If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
- The most recent electrocardiogram must be within 180 days of enrollment. NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG...
- Plans to undergo a de novo ablation procedure with the Volt PFA Catheter due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
- At least 18 years of age
- Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
- Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.
What rules you out
- Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
- Known presence of cardiac thrombus
- Known Left ventricular ejection fraction \< 35% as assessed with echocardiography within 360 days of index procedure
- New York Heart Association (NYHA) class III or IV heart failure
- Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
- Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure
- Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
- Unstable angina
- Stroke or TIA (transient ischemic attack) within the last 90 days
- Heart disease in which corrective surgery is anticipated within 180 days after procedure
- History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
- Contraindication to long term anti-thromboembolic therapy
- Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
- Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
- Previous tricuspid or mitral valve replacement or repair
- Patients with prosthetic valves
- Patients with a myxoma
- Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
- Stent, constriction, or stenosis in a pulmonary vein
- Rheumatic heart disease
- Hypertrophic cardiomyopathy
- Diagnosed with amyloidosis or atrial amyloidosis
- Active systemic infection
- Renal failure requiring dialysis
- Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic...
- Presence of an implanted LAA closure device
- Patient is currently participating in another clinical study that may confound the results of this of this post market evaluation; for example, enrolled in another study with an active treatment arm
- Unlikely to survive the protocol follow up period of 12 months
- Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with...
- Individuals without legal authority
- Individuals unable to read or write
The study team makes the final eligibility decision.
Where it's taking place
- Linz, Austria
- Bruges, Belgium
- Brussels, Belgium
- Copenhagen, Denmark
- Paris, France
- Pessac, France
- Toulouse, France
- Bad Oeynhausen, Germany
- Cologne, Germany
- Hamburg, Germany
- München, Germany
- Dublin, Ireland
- Ancona, Italy
- Milan, Italy
- Groningen, Netherlands
- Nieuwegein, Netherlands
- Warsaw, Poland
- Lisbon, Portugal
- A Coruña, Spain
- Madrid, Spain
+ 2 more site(s).
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 Linz, Austria; Bruges, Belgium; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Pessac, France and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.