Recruiting NCT06099730
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulsed Field Ablation (PFA).
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.
Interventions
- Device Pulsed Field Ablation (PFA)
PFA using Irreversible Electroporation (IRE) Ablation System
Primary outcome measures
- Incidence of early onset primary adverse events (PAEs) [Time frame: within seven (7) days of an ablation procedure]
- Freedom from documented atrial tachyarrhythmia episodes [Time frame: effectiveness evaluation period (Day 91-Day 365)]
- Freedom from acute procedural failure [Time frame: during ablation procedure]
Eligibility criteria
Inclusion criteria
- Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically documented within 24 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to ECG, Transtelephonic monitoring (TTM), Zio patch monitor, telemetry strip, or consumer devices
- Age 18-80 years
- Willing and capable of providing written consent
- Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion criteria
- Previous surgical or catheter ablation for AF
- Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, or intracardiac echocardiogram at the beginning of the procedure).
- Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the PFA energy field
- Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
- Life expectancy less than 12 months
- Currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- St. Bernard's Heart and Vascular Center — Jonesboro
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
- Mount Sinai Hospital — New York
- Montefiore Medical Center — New York
- Texas Cardiac Arrhythmia Institute/Research Foundation — Austin
Identifiers
NCT: NCT06099730 · 2023P002605