Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
Massachusetts General Hospital
Study ID
NCT06099730
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Pulsed Field Ablation (PFA) — DEVICE
    PFA using Irreversible Electroporation (IRE) Ablation System

Study Details

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.

Key Dates

Start date
Dec 14, 2023
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
442 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Pulsed Field Ablation
    This is a non-randomized one arm study.

Primary Outcome Measure

Incidence of early onset primary adverse events (PAEs) [ Time Frame: within seven (7) days of an ablation procedure ]

Locations (6)

FacilityCityStateZIP
St. Bernard's Heart and Vascular CenterJonesboroArkansas72401
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Massachusetts General HospitalBostonMassachusetts02114
Montefiore Medical CenterNew YorkNew York10467
Mount Sinai HospitalNew YorkNew York10029
Texas Cardiac Arrhythmia Institute/Research FoundationAustinTexas78705

Find similar trials in Jonesboro, AR

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
St. Bernard's Heart and Vascular Center· Jonesboro, ARBeth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MAMontefiore Medical Center· New York, NYMount Sinai Hospital· New York, NYTexas Cardiac Arrhythmia Institute/Research Foundation· Austin, TX

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