RESOLVE-AF: 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. (RESOLVE-AF)
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| ClinicalTrials.gov Identifier: NCT05883631 |
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Recruitment Status :
Recruiting
First Posted : June 1, 2023
Last Update Posted : February 29, 2024
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Sponsor:
Ablacon, Inc.
Information provided by (Responsible Party):
Cortex ( Ablacon, Inc. )
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation Atrial Fibrillation, Persistent Atrial Fibrillation Paroxysmal Arrhythmia Arrhythmias, Cardiac Atrial Flutter Atrial Fibrillation, Paroxysmal or Persistent Atrial Arrhythmia Atrial Tachycardia | Device: EGF-Mapping and EGF-Guided Ablation of AF Sources Device: EGF-Mapping of AF Sources (no ablation) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 400 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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. |
| Actual Study Start Date : | October 23, 2023 |
| Estimated Primary Completion Date : | March 31, 2025 |
| Estimated Study Completion Date : | March 31, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Atrial Fibrillation
| Arm | Intervention/treatment |
|---|---|
| Experimental: De Novo Subjects: Ablacath Mapping Catheter/Ablamap System |
Device: EGF-Mapping of AF Sources (no ablation)
Ablacath™ Mapping Catheter, Ablacath™ Mapping Catheter Accessory Cables, Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software |
| Experimental: Redo Subjects: Ablacath Mapping Catheter/Ablamap System |
Device: EGF-Mapping and EGF-Guided Ablation of AF Sources
Ablacath™ Mapping Catheter, Ablacath™ Mapping Catheter Accessory Cables, Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software |
Primary Outcome Measures :
- Freedom from documented AF episodes lasting > 30 seconds (with or without AAD) following the index procedure through 12-months [ Time Frame: 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 [ Time Frame: 7 days ]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 [ Time Frame: 12 months ]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 [ Time Frame: 30 days ]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 [ Time Frame: 12 months ]Evaluation of patient freedom from AF
- Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time [ Time Frame: Index or Repeat Procedure ]Evaluation of index or repeat procedure times
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- Left atrial (LA) diameter ≤ 5.5 cm or LA volume index ≤ 50 mL/m2 (use whichever measure is available or if both available, use the lesser of the two to qualify)
Exclusion Criteria:
- De Novo paroxysmal AF
- AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
- Cardiac surgery or intervention within the past 90 days (e.g. percutaneous coronary intervention, ablation for ventricular arrhythmias, left atrial appendage occlusion devices, atrial septal defect closure devices, transcatheter aortic valve replacement)
- Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
- Myocardial infarction within the past 90 days
- Severe valvular disease or prosthetic valve(s)
- Contraindication to therapeutic anticoagulation
- Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV
- Positive pregnancy test
- Any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias
- Enrollment in another investigational study evaluating another device, biologic or drug
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05883631
Contacts
| Contact: Eliza Lawrence | 650-933-4490 | elawrence@cortexep.com | |
| Contact: Erik Harks | +31 11209268 | eharks@cortexep.com |
Locations
Show 20 study locations
Sponsors and Collaborators
Ablacon, Inc.
Investigators
| Principal Investigator: | Kent Nilsson, MD | Piedmont Athens Regional | |
| Principal Investigator: | Lucas Boersma, Prof. MD. | St. Antonius Hospital |
| Responsible Party: | Ablacon, Inc. |
| ClinicalTrials.gov Identifier: | NCT05883631 |
| Other Study ID Numbers: |
CP006 |
| First Posted: | June 1, 2023 Key Record Dates |
| Last Update Posted: | February 29, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Tachycardia Atrial Flutter |
Heart Diseases Cardiovascular Diseases Pathologic Processes Cardiac Conduction System Disease |