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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 29, 2024
Sponsor:
Information provided by (Responsible Party):
Cortex ( Ablacon, Inc. )

Tracking Information
First Submitted Date  ICMJE May 22, 2023
First Posted Date  ICMJE June 1, 2023
Last Update Posted Date February 29, 2024
Actual Study Start Date  ICMJE October 23, 2023
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2023)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2023)
  • 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 ]
    SAE composite as adjudicated by a CEC for relatedness to device or procedure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2023)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2023)		 Freedom from a composite of SAE occurring within 30 days from post-index ablation procedure [ Time Frame: 30 days ]
AE composite as adjudicated by a CEC for relatedness to device or procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Atrial Fibrillation, Persistent
  • Atrial Fibrillation Paroxysmal
  • Arrhythmia
  • Arrhythmias, Cardiac
  • Atrial Flutter
  • Atrial Fibrillation, Paroxysmal or Persistent
  • Atrial Arrhythmia
  • Atrial Tachycardia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: De Novo Subjects: Ablacath Mapping Catheter/Ablamap System
    Intervention: Device: EGF-Mapping of AF Sources (no ablation)
  • Experimental: Redo Subjects: Ablacath Mapping Catheter/Ablamap System
    Intervention: Device: EGF-Mapping and EGF-Guided Ablation of AF Sources
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2023)		 400
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2023)		 500
Estimated Study Completion Date  ICMJE March 31, 2025
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eliza Lawrence 650-933-4490 elawrence@cortexep.com
Contact: Erik Harks +31 11209268 eharks@cortexep.com
Listed Location Countries  ICMJE Belgium,   Czechia,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05883631
Other Study ID Numbers  ICMJE CP006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Cortex ( Ablacon, Inc. )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ablacon, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kent Nilsson, MD Piedmont Athens Regional
Principal Investigator: Lucas Boersma, Prof. MD. St. Antonius Hospital
PRS Account Cortex
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP