search
Back to results

CardioFocus HeartLight Post-Approval Study

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HeartLight
Ablation
Sponsored by
CardioFocus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation
  • failure of at least one anti-arrhythmic drug
  • others

Exclusion Criteria:

  • overall good health as established by multiple criteria

Sites / Locations

  • University of Arizona Sarver HeartCenterRecruiting
  • University of IllinoisRecruiting
  • Mount Sinai HospitalRecruiting
  • University Of Virginia Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System

Outcomes

Primary Outcome Measures

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
The outcome will be assessed from 91 days post procedure through 12 months

Secondary Outcome Measures

Full Information

First Posted
May 24, 2017
Last Updated
March 9, 2023
Sponsor
CardioFocus
search

1. Study Identification

Unique Protocol Identification Number
NCT03168659
Brief Title
CardioFocus HeartLight Post-Approval Study
Official Title
Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioFocus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
This is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the HeartLight System during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System
Intervention Type
Device
Intervention Name(s)
HeartLight
Intervention Description
HeartLight Endoscopic Ablation System
Intervention Type
Procedure
Intervention Name(s)
Ablation
Intervention Description
Pulmonary vein isolation ablation
Primary Outcome Measure Information:
Title
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
Description
The outcome will be assessed from 91 days post procedure through 12 months
Time Frame
Day 91 through 12 months
Other Pre-specified Outcome Measures:
Title
Chronic Effectiveness
Description
Freedom from symptomatic AF or symptomatic atypical AFL/AT
Time Frame
36 months
Title
Chronic Safety
Description
Reporting of adverse events
Time Frame
36 months
Title
Effect of Operator Experience on primary effectiveness endpoint
Description
Assess relationship between operator experience and freedom from symptomatic AF or symptomatic atypical AFL/AT
Time Frame
36 months
Title
Effect of Operator Experience on primary safety endpoint
Description
Assess relationship between operator experience and rate of Primary Adverse Events (PAE)
Time Frame
36 months
Title
Safety Outcomes by Gender
Description
Assess relationship between gender and rate of PAEs
Time Frame
12 months and 36 months
Title
Neurological Events
Description
Assess relationship between neurological events and procedural parameters
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation failure of at least one anti-arrhythmic drug others Exclusion Criteria: overall good health as established by multiple criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
508-658-7253
Email
lhausmann@cardiofocus.com
Facility Information:
Facility Name
University of Arizona Sarver HeartCenter
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathew Hutchinson, MD
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Wissner, MD
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Betsy Ellsworth, MSN, ANP
Email
betsy.ellsworth@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Srini Dukkipati, MD
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Jane Strickland
Phone
434-982-6401
Email
MJS7W@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
J. Michael Mangrum, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CardioFocus HeartLight Post-Approval Study

We'll reach out to this number within 24 hrs