NCT03168659

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
30mo left

Started Jun 2017

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jun 2017Oct 2028

First Submitted

Initial submission to the registry

May 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

June 16, 2017

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

9.3 years

First QC Date

May 24, 2017

Last Update Submit

August 19, 2024

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 91 through 12 months

Other Outcomes (6)

  • Chronic Effectiveness

    36 months

  • Chronic Safety

    36 months

  • Effect of Operator Experience on primary effectiveness endpoint

    36 months

  • +3 more other outcomes

Study Arms (1)

Treatment

OTHER

Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System

Device: HeartLightProcedure: Ablation

Interventions

HeartLightDEVICE

HeartLight Endoscopic Ablation System

Treatment
AblationPROCEDURE

Pulmonary vein isolation ablation

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • overall good health as established by multiple criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Arizona Sarver HeartCenter

Tucson, Arizona, 85724, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

University Of Virginia Health System

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Director

CONTACT

508-658-7253lhausmann@cardiofocus.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 30, 2017

Study Start

June 16, 2017

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2028

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(4)