NCT06056557Completed
Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
Source: ClinicalTrials.gov · Last updated 2 Sept 2025
Brief summary (registry, in English)
The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSE™ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated ablation procedures.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 141 (actual)
- First submitted
- 6 Sept 2023
- Start date
- 28 Sept 2023
- Primary completion date
- 18 Apr 2025
- Lead sponsor
- Vivek Reddy
- Diseases
- Atrial fibrillation
- NCT number
- NCT06056557
What you commit to
- Study type: Interventional
- Participants enrolled: 141
- From 28 Sept 2023 to the primary completion date, 18 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous PCI/MI within the past 1 month
- Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
Other illness
- Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.)
- 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.
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
Age
- Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial.
Other
- Documented "active" left atrial thrombus
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.