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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
Recruitment Status : Recruiting
First Posted : June 1, 2023
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
Cortex ( Ablacon, Inc. )

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

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.

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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


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 :
  1. 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

  2. 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

  3. 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 :
  1. 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

  2. Overall reduction in burden of AF for subset of patients with implantable loop recorder [ Time Frame: 12 months ]
    Evaluation of patient freedom from AF

  3. 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



Information from the National Library of Medicine

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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:

  1. Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia
  2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law
  3. 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:

  1. De Novo paroxysmal AF
  2. AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
  3. 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)
  4. Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
  5. Myocardial infarction within the past 90 days
  6. Severe valvular disease or prosthetic valve(s)
  7. Contraindication to therapeutic anticoagulation
  8. Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV
  9. Positive pregnancy test
  10. Any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias
  11. 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
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Contact: Eliza Lawrence 650-933-4490 elawrence@cortexep.com
Contact: Erik Harks +31 11209268 eharks@cortexep.com

Locations
Show Show 20 study locations
Sponsors and Collaborators
Ablacon, Inc.
Investigators
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Principal Investigator: David Haines, MD Beaumont Health
Principal Investigator: Lucas Boersma, Prof. MD. St. Antonius Hospital
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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 6, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
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