Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment o… (NCT06056557) | Clinical Trial Compass
CompletedNot Applicable
Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
United States141 participantsStarted 2023-09-28
Plain-language summary
The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSEâ„¢ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated ablation procedures.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older.
* Diagnosed with atrial fibrillation or atrial atypical atrial flutter (typical flutter may also be ablated provided that the typical flutter occurs in addition to atrial fibrillation or atypical flutter; that is, typical flutter as the sole arrhythmia should not undergo PFA).
* Previous surgical or catheter ablation for atrial fibrillation is allowed
* Planned for a catheter ablation procedure
* Able and willing to provide written consent and comply with all testing and follow-up requirements
* Have in place or are planned to receive an implantable loop recorder, pacemaker or defibrillator capable of recording atrial rhythm
Exclusion Criteria:
* Documented "active" left atrial thrombus
* Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.)
* Previous PCI/MI within the past 1 month
* Active systemic infection or sepsis
* Uncontrolled heart failure - New York Heart Association (NYHA) function class IV.
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation.
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment.
* Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial.
* Life expectancy or other disease processes likely to limit survival to less than 1…
What they're measuring
1
Number of participants with acute procedural success