Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Volta Medical
Study ID
NCT04702451
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dispersion ablation + PVI — PROCEDURE
    Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
  • VX1 — DEVICE
    VX1-based dispersion mapping
  • PVI — PROCEDURE
    Pulmonary vein antrum isolation

Study Details

Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI). The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.

Key Dates

Start date
Feb 12, 2021
Status verified
Sep 2025
Primary completion
Dec 27, 2023
Completion
Dec 27, 2023

Study Design

Enrollment
377 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tailored
    Tailored ablation strategy
  • Active Comparator: Anatomical
    Anatomical ablation strategy

Primary Outcome Measure

Number of Participants Free From Documented AF After One Ablation Procedure [ Time Frame: 12 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Grandview Medical CenterBirminghamAlabama35243-
Ascension St. Vincent'sJacksonvilleFlorida32204-
Washington UniversitySt LouisMissouri63130-
Northwell HealthNew YorkNew York10075-
New York Presbyterian Queens HospitalQueensNew York11355-
Ohio State UniversityColumbusOhio43210-
Rhode Island HospitalProvidenceRhode Island02903-
Inova FairfaxFalls ChurchVirginia22042-

Find similar trials in Birmingham, AL

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Grandview Medical Center· Birmingham, ALAscension St. Vincent's· Jacksonville, FLWashington University· St Louis, MONorthwell Health· New York, NYNew York Presbyterian Queens Hospital· Queens, NYOhio State University· Columbus, OH

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