Back to resultsClinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
HeartLight X3
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- paroxysmal atrial fibrillation failure of at least one AAD others
Exclusion Criteria:
- overall good health as established by multiple criteria
Sites / Locations
- Nemocnice Na Homolce
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HeartLight X3
Arm Description
Pulmonary vein isolation using HeartLight X3
Outcomes
Primary Outcome Measures
Ablation time
Ablation time
Secondary Outcome Measures
Procedure time
Procedure time
PV Isolation
Percent of isolated pulmonary veins
PAE Rate
Primary Adverse Event rate
AF Free Rate
6- and 12-month chronic results
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03470636
Brief Title
Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon
Official Title
Clinical Study of the HeartLight X3 Endoscopic Ablation System (EAS) With Excalibur Balloon Compared to HeartLight System in the Treatment of Symptomatic Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
January 16, 2020 (Actual)
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
No
5. Study Description
Brief Summary
The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the current HeartLight catheter in the treatment of 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
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HeartLight X3
Arm Type
Experimental
Arm Description
Pulmonary vein isolation using HeartLight X3
Intervention Type
Device
Intervention Name(s)
HeartLight X3
Intervention Description
Pulmonary vein isolation
Primary Outcome Measure Information:
Title
Ablation time
Description
Ablation time
Time Frame
Acute - at the end of the index procedure
Secondary Outcome Measure Information:
Title
Procedure time
Description
Procedure time
Time Frame
Acute - at the end of the index procedure
Title
PV Isolation
Description
Percent of isolated pulmonary veins
Time Frame
Acute - at the end of the index procedure
Title
PAE Rate
Description
Primary Adverse Event rate
Time Frame
30 Days
Title
AF Free Rate
Description
6- and 12-month chronic results
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
paroxysmal atrial fibrillation failure of at least one AAD others
Exclusion Criteria:
overall good health as established by multiple criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burke T. Barrett
Organizational Affiliation
CardioFocus, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Nemocnice Na Homolce
City
Prague
Country
Czechia
12. IPD Sharing Statement
Citations:
PubMed Identifier
33570423
Citation
Schmidt B, Petru J, Chun KRJ, Sediva L, Bordignon S, Chen S, Neuzil P. Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System. Circ Arrhythm Electrophysiol. 2021 Mar;14(3):e009544. doi: 10.1161/CIRCEP.120.009544. Epub 2021 Feb 11.
Results Reference
derived
Learn more about this trial
Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon
We'll reach out to this number within 24 hrs