MedTrace Logo

CardioFocus HeartLight Post-Approval Study

NCT03168659 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-08-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

HeartLight

HeartLight Endoscopic Ablation System

PROCEDURE

Ablation

Pulmonary vein isolation ablation

Sponsors & Collaborators

  • CardioFocus

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2026-10-31
Completion
2028-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03168659 on ClinicalTrials.gov