Back to resultsCardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation (CF²)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ablation catheter
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patient must not have undergone a previous ablation for the treatment of PAF
- AF Type - Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) where PAF is defined as recurrent (two or more) episodes of AF that terminate spontaneously in less than seven days, usually less than 48 hours
Exclusion Criteria:
- Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
- Diagnosed with persistent atrial fibrillation defined as recurrent episodes lasting more than 7 and less than 365 days
- More than 4 electrical cardioversions in the year prior to enrollment but not including cardioversions performed within 48 hours of arrhythmia onset
- Documented left atrial thrombus on imaging
- Cannot be removed from anti-arrhythmic drugs for other reasons than atrial fibrillation
- New York Heart Association (NYHA) functional Class III or Class IV heart failure
- Left ventricular ejection fraction < 30%
- Left atrial size > 55 mm as measured in the parasternal antero-posterior view
- Myocardial infarction within 60 days prior to enrolment
- Woman of childbearing potential who is pregnant, lactating or not using adequate birth control
Sites / Locations
- Hartcentrum OLV Aalst
- Hartcentrum Hasselt Jessa Ziekenhuis
- Nemocnice Na Homolce
- Universitätsklinik Erlangen
- Isar Herz Zentrum
- St. Vinzenz Hospital Köln
- UKSH, Universitäres Herzzentrum
- Vivantes Klinikum Am Urban
- Asklepios Klinik St. Georg
- Universitäres Herz- und Gefäßzentrum UKE Hamburg
- Blackpool Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
HeartLight® EGLA
Contact Force Sensing Irrigated RF ablation
Arm Description
Participants will be treated with the endoscopically guided laser ablation catheter
Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter
Outcomes
Primary Outcome Measures
Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs
Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure
Secondary Outcome Measures
Acute procedure success
Confirmation of electrical isolation with a circular mapping catheter
Procedure and fluoroscopy time
Time will be taken
Incidence of peri-procedural complications
E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death
Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs
Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03056222
Brief Title
CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
Acronym
CF²
Official Title
CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I-Med-Pro GmbH
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.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HeartLight® EGLA
Arm Type
Active Comparator
Arm Description
Participants will be treated with the endoscopically guided laser ablation catheter
Arm Title
Contact Force Sensing Irrigated RF ablation
Arm Type
Active Comparator
Arm Description
Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter
Intervention Type
Device
Intervention Name(s)
Ablation catheter
Intervention Description
Ablation of paroxysmal atrial fibrillation
Primary Outcome Measure Information:
Title
Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs
Description
Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure
Time Frame
12 months post procedure
Secondary Outcome Measure Information:
Title
Acute procedure success
Description
Confirmation of electrical isolation with a circular mapping catheter
Time Frame
30 minutes post procedure
Title
Procedure and fluoroscopy time
Description
Time will be taken
Time Frame
During procedure
Title
Incidence of peri-procedural complications
Description
E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death
Time Frame
From procedure to 12 months post procedure
Title
Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs
Description
Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure
Time Frame
12 months post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must not have undergone a previous ablation for the treatment of PAF
AF Type - Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) where PAF is defined as recurrent (two or more) episodes of AF that terminate spontaneously in less than seven days, usually less than 48 hours
Exclusion Criteria:
Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
Diagnosed with persistent atrial fibrillation defined as recurrent episodes lasting more than 7 and less than 365 days
More than 4 electrical cardioversions in the year prior to enrollment but not including cardioversions performed within 48 hours of arrhythmia onset
Documented left atrial thrombus on imaging
Cannot be removed from anti-arrhythmic drugs for other reasons than atrial fibrillation
New York Heart Association (NYHA) functional Class III or Class IV heart failure
Left ventricular ejection fraction < 30%
Left atrial size > 55 mm as measured in the parasternal antero-posterior view
Myocardial infarction within 60 days prior to enrolment
Woman of childbearing potential who is pregnant, lactating or not using adequate birth control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Metzner, PD Dr. med.
Organizational Affiliation
Universitäres Herz- und Gefäßzentrum UKE Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartcentrum OLV Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Hartcentrum Hasselt Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Nemocnice Na Homolce
City
Prague
ZIP/Postal Code
15030
Country
Czechia
Facility Name
Universitätsklinik Erlangen
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Facility Name
Isar Herz Zentrum
City
München
State/Province
Bavaria
ZIP/Postal Code
80331
Country
Germany
Facility Name
St. Vinzenz Hospital Köln
City
Köln
State/Province
NRW
ZIP/Postal Code
50733
Country
Germany
Facility Name
UKSH, Universitäres Herzzentrum
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23562
Country
Germany
Facility Name
Vivantes Klinikum Am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitäres Herz- und Gefäßzentrum UKE Hamburg
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation
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