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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06099730
Other study ID # 2023P002605
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 14, 2023
Est. completion date November 2024

Study information

Verified date May 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pulsed Field Ablation (PFA)
PFA using Irreversible Electroporation (IRE) Ablation System

Locations

Country Name City State
United States Texas Cardiac Arrhythmia Institute/Research Foundation Austin Texas
United States Massachusetts General Hospital Boston Massachusetts
United States Mount Sinai Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of early onset primary adverse events (PAEs) within seven (7) days of an ablation procedure
Primary Freedom from documented atrial tachyarrhythmia episodes effectiveness evaluation period (Day 91-Day 365)
Primary Freedom from acute procedural failure during ablation procedure
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