Back to resultsClinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy. (RESOLVE-AF)
Primary Purpose
Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Fibrillation Paroxysmal
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ablacath™ Mapping Catheter, Ablacath™ Mapping Catheter Accessory Cables, Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria: Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law Exclusion Criteria: De Novo paroxysmal AF Atrial fibrillation from a reversible cause (ex. Surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.) Cardiac surgery or intervention within the past 90 days (ex. Percutaneous Coronary Intervention, ablation for ventricular arrhythmias, LAA occlusion devices, Atrial Septal Defect closure devices, Transcatheter Aortic Valve Replacement) Presence of transvenous pacing or defibrillator leads Myocardial infarction within the past 90 days LA diameter >5.5 cm or LA volume index > 45 mL/m2 Severe valvular disease or prosthetic valve Contraindication to therapeutic anticoagulation Decompensated heart failure Positive pregnancy Any other contraindication to an intra-cardiac mapping and ablation of atrial arrhythmias Enrollment in another investigational study evaluating another device, biologic or drug
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Abacath Mapping Catheter/Ablamap System
Arm Description
Outcomes
Primary Outcome Measures
Freedom from documented AF episodes lasting > 30 seconds (with or without AAD) following the index procedure through 12-months
Evaluated by assessing rate of subjects free from AF following index procedure through 12 months with or without AAD
Freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure
Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure
Demonstrate the predictive value of EGF phenotype for ablation outcome
Evaluated through the comparison ablation outcomes between redo and de novo AF subjects
Secondary Outcome Measures
Freedom from a composite of SAE occurring within 30 days from post-index ablation procedure
Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure
Overall reduction in burden of AF for subset of patients with implantable loop recorder
Evaluation of patient freedom from AF
Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time
Evaluation of index or repeat procedure times
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05883631
Brief Title
Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.
Acronym
RESOLVE-AF
Official Title
Prospective, Single Arm, Multi-center, Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-pulmonary Vein Sources of Atrial Fibrillation and Guide Ablation Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures.
Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.
Detailed Description
Subjects with all types of AF who are candidates for catheter ablation of their AF. The study will enroll up to 400 subjects in 25 centers globally.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Fibrillation Paroxysmal, Arrhythmia, Arrhythmias, Cardiac, Atrial Flutter, Atrial Fibrillation, Paroxysmal or Persistent, Atrial Arrhythmia, Atrial Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Abacath Mapping Catheter/Ablamap System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ablacath™ Mapping Catheter, Ablacath™ Mapping Catheter Accessory Cables, Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software
Intervention Description
EGF-Mapping and EGF-Guided Ablation of AF Sources
Primary Outcome Measure Information:
Title
Freedom from documented AF episodes lasting > 30 seconds (with or without AAD) following the index procedure through 12-months
Description
Evaluated by assessing rate of subjects free from AF following index procedure through 12 months with or without AAD
Time Frame
12 months
Title
Freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure
Description
Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure
Time Frame
7 days
Title
Demonstrate the predictive value of EGF phenotype for ablation outcome
Description
Evaluated through the comparison ablation outcomes between redo and de novo AF subjects
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Freedom from a composite of SAE occurring within 30 days from post-index ablation procedure
Description
Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure
Time Frame
30 days
Title
Overall reduction in burden of AF for subset of patients with implantable loop recorder
Description
Evaluation of patient freedom from AF
Time Frame
12 months
Title
Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time
Description
Evaluation of index or repeat procedure times
Time Frame
Index or Repeat 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:
Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia
Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law
Exclusion Criteria:
De Novo paroxysmal AF
Atrial fibrillation from a reversible cause (ex. Surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
Cardiac surgery or intervention within the past 90 days (ex. Percutaneous Coronary Intervention, ablation for ventricular arrhythmias, LAA occlusion devices, Atrial Septal Defect closure devices, Transcatheter Aortic Valve Replacement)
Presence of transvenous pacing or defibrillator leads
Myocardial infarction within the past 90 days
LA diameter >5.5 cm or LA volume index > 45 mL/m2
Severe valvular disease or prosthetic valve
Contraindication to therapeutic anticoagulation
Decompensated heart failure
Positive pregnancy
Any other contraindication to an intra-cardiac mapping and ablation of atrial arrhythmias
Enrollment in another investigational study evaluating another device, biologic or drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliza Lawrence
Phone
650-933-4490
Email
el@ablacon.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Harks
Phone
+31 11209268
Email
eric.harks@ablacon.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.
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