Back to resultsFLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology (FLOW-AF)
Primary Purpose
Atrial Fibrillation, Persistent
Status
Active
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Ablamap Software
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation, Persistent
Eligibility Criteria
Inclusion Criteria:
- Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias.
- Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
- Subjects with a history of documented symptomatic, persistent or longstanding persistent atrial fibrillation < 36 months.
- Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months.
- Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of AF (not applicable to De Novo subjects)
Exclusion Criteria:
- LA diameter > 5.5 cm.
- Left ventricular ejection fraction (LVEF) < 35%.
- Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
- Coagulopathy, bleeding diathesis or suspected procoagulant state.
- Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
- Positive pregnancy test results for female patients of childbearing potential or breast feeding.
- Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study.
- Mitral valve stenosis and/or severe mitral regurgitation.
- Valvular atrial fibrillation.
- Prosthetic valves.
- NYHA Class IV.
- History of MI within 3 months prior to procedure.
- Atrial septal defect (ASD) or left atrial appendage (LAA) closure device.
- Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis).
- Life expectancy < 12 months based on medical history or the medical judgement of the investigator.
Presence of any transvenous pacing, Implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) leads.
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Sites / Locations
- Nemocnice Na Homolce Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EGF-Guided Ablation Therapy
Control - No Ablation Therapy
Arm Description
Subjects randomized to "therapy" will be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software).
Subjects randomized to "control" will not be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software). The subjects will be cardioverted (as applicable) and the procedure will end.
Outcomes
Primary Outcome Measures
Primary Efficacy Endpoint: the ability to successfully ablate AF sources identified by the EGF algorithm as measured by EGF maps of the atria pre and post ablation to determine if there is a diminished or absence of the source.
Acute procedure success defined as the ability to successfully ablate AF sources identified by the EGF algorithm
Primary Safety Endpoint: Freedom from serious adverse events
Freedom from serious adverse events related to the procedure through 7 days following the randomization procedure.
Secondary Outcome Measures
Secondary Efficacy Endpoints: Consistency of sources
Consistency of sources identified by the Ablacon EGF algorithm between the randomization procedure and any applicable subsequent EGF-guided ablation procedures as assessed by remapping of the atria and the algorithm's ability to reproduce sources identified by a previous procedure
Secondary Efficacy Endpoints: Freedom from documented episodes of AF recurrence
Freedom from documented episodes of atrial fibrillation recurrence following the blanking period (90 days post procedure through 12 months). Documentation will be from Holter recordings or EKGs.
Secondary Efficacy Endpoints: Total number of EGF source ablations
Total number of EGF source ablations (count number of ablations during the procedure)
Secondary Efficacy Endpoints: Total time of EGF source ablations
Total time of EGF source ablations (seconds)
Secondary Efficacy Endpoints
Total fluoroscopy time (min/sec)
Secondary Efficacy Endpoints
Total fluoroscopy dose (mgy)
Secondary Efficacy Endpoints: Overall Procedure time
Overall Procedure time (hours/minutes)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04473963
Brief Title
FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology
Acronym
FLOW-AF
Official Title
A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW (EGF) Algorithm Technology (Ablamap Software) to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
November 29, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ablacon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap Software).
Detailed Description
The objective of this study is to evaluate the reliability of the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap Software) to identify atrial fibrillation sources and guide ablation therapy in patients with persistent atrial fibrillation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Persistent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EGF-Guided Ablation Therapy
Arm Type
Experimental
Arm Description
Subjects randomized to "therapy" will be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software).
Arm Title
Control - No Ablation Therapy
Arm Type
No Intervention
Arm Description
Subjects randomized to "control" will not be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software). The subjects will be cardioverted (as applicable) and the procedure will end.
Intervention Type
Device
Intervention Name(s)
Ablamap Software
Other Intervention Name(s)
Ablamap Electrographic Flow Algorithm Technology
Intervention Description
Subjects will receive cardiac ablation guided by the Ablamap software. The software will identify atrial fibrillation sources to help guide ablation therapy in patients with persistent atrial fibrillation. Subjects will undergo a cardioversion post ablation, as necessary.
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint: the ability to successfully ablate AF sources identified by the EGF algorithm as measured by EGF maps of the atria pre and post ablation to determine if there is a diminished or absence of the source.
Description
Acute procedure success defined as the ability to successfully ablate AF sources identified by the EGF algorithm
Time Frame
During the Procedure
Title
Primary Safety Endpoint: Freedom from serious adverse events
Description
Freedom from serious adverse events related to the procedure through 7 days following the randomization procedure.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Secondary Efficacy Endpoints: Consistency of sources
Description
Consistency of sources identified by the Ablacon EGF algorithm between the randomization procedure and any applicable subsequent EGF-guided ablation procedures as assessed by remapping of the atria and the algorithm's ability to reproduce sources identified by a previous procedure
Time Frame
Post procedure through 12 months
Title
Secondary Efficacy Endpoints: Freedom from documented episodes of AF recurrence
Description
Freedom from documented episodes of atrial fibrillation recurrence following the blanking period (90 days post procedure through 12 months). Documentation will be from Holter recordings or EKGs.
Time Frame
3-12 months
Title
Secondary Efficacy Endpoints: Total number of EGF source ablations
Description
Total number of EGF source ablations (count number of ablations during the procedure)
Time Frame
During the procedure
Title
Secondary Efficacy Endpoints: Total time of EGF source ablations
Description
Total time of EGF source ablations (seconds)
Time Frame
During the procedure
Title
Secondary Efficacy Endpoints
Description
Total fluoroscopy time (min/sec)
Time Frame
During the procedure
Title
Secondary Efficacy Endpoints
Description
Total fluoroscopy dose (mgy)
Time Frame
During the procedure
Title
Secondary Efficacy Endpoints: Overall Procedure time
Description
Overall Procedure time (hours/minutes)
Time Frame
During the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias.
Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
Subjects with a history of documented symptomatic, persistent or longstanding persistent atrial fibrillation < 36 months.
Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months.
Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of AF (not applicable to De Novo subjects)
Exclusion Criteria:
LA diameter > 5.5 cm.
Left ventricular ejection fraction (LVEF) < 35%.
Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
Coagulopathy, bleeding diathesis or suspected procoagulant state.
Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
Positive pregnancy test results for female patients of childbearing potential or breast feeding.
Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study.
Mitral valve stenosis and/or severe mitral regurgitation.
Valvular atrial fibrillation.
Prosthetic valves.
NYHA Class IV.
History of MI within 3 months prior to procedure.
Atrial septal defect (ASD) or left atrial appendage (LAA) closure device.
Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis).
Life expectancy < 12 months based on medical history or the medical judgement of the investigator.
Presence of any transvenous pacing, Implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) leads.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petr Neuzil, MD
Organizational Affiliation
Principal Investigator - Czech Republic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamas Szili-Torok, MD
Organizational Affiliation
Principal Investigator - The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Spitzer, MD
Organizational Affiliation
Principal Investigator - Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemocnice Na Homolce Hospital
City
Prague
State/Province
Czech Republic
ZIP/Postal Code
150 30
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology
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