CardioFocus HeartLight Post-Approval Study

Part of paid clinical trials in Tucson, Arizona.

Sponsor
CardioFocus
Study ID
NCT03168659
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • HeartLight — DEVICE
    HeartLight Endoscopic Ablation System
  • Ablation — PROCEDURE
    Pulmonary vein isolation ablation

Study Details

This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.

Key Dates

Start date
Jun 16, 2017
Status verified
Aug 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2028

Study Design

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

Arms

  • Other: Treatment
    Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System

Primary Outcome Measure

The proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter/atrial tachycardia (AFL/AT) lasting longer than 30 seconds post the 90 day blanking period [ Time Frame: Day 91 through 12 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Arizona Sarver HeartCenterTucsonArizona85724
Mathew Hutchinson, MD (PRINCIPAL_INVESTIGATOR)
University of IllinoisChicagoIllinois60612
Erik Wissner, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Betsy Ellsworth, MSN, ANP
[email protected]
Srini Dukkipati, MD (PRINCIPAL_INVESTIGATOR)
University Of Virginia Health SystemCharlottesvilleVirginia22908
Mary Jane Strickland
[email protected]
434-982-6401
J. Michael Mangrum, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
University of Arizona Sarver HeartCenter· Tucson, AZUniversity of Illinois· Chicago, ILMount Sinai Hospital· New York, NYUniversity Of Virginia Health System· Charlottesville, VA

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