Status:
COMPLETED
Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
Lead Sponsor:
Vivek Reddy
Conditions:
Atrial Fibrillation, Paroxysmal or Persistent
Atrial Fibrillation and Flutter
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 TRUPULSE™ Generator, and the compatible E...
Detailed Description
By virtue of its efficiency, safety profile, and potential for improved efficacy in certain patient populations (e.g., thickened atrial tissue of hypertrophic cardiomyopathy (HCM) patients), there is ...
Eligibility Criteria
Inclusion
- 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
- 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 12 months.
- Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2025
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT06056557
Start Date
September 28 2023
End Date
April 18 2025
Last Update
September 2 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029