ClinicalTrials.gov
History of Changes for Study: NCT05883631
Prospective, Single Arm, Multicenter, Clinical Investigation of the Ablacath™ Mapping Catheter and Ablamap System to Identify and RESOLVE the Source of Atrial Fibrillation and Guide Ablation Therapy. (RESOLVE-AF)
Latest version (submitted February 28, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 22, 2023 None (earliest Version on record)
2 June 1, 2023 Outcome Measures, Study Description, Study Identification, IPDSharing, Eligibility, Conditions and Study Status
3 June 15, 2023 Study Status and Study Identification
4 September 17, 2023 Study Status, Contacts/Locations, Eligibility, Study Design and Study Description
5 November 29, 2023 Recruitment Status, Study Status, Contacts/Locations, Eligibility and Oversight
6 December 4, 2023 Study Status, Contacts/Locations and Study Identification
7 February 2, 2024 Arms and Interventions, Contacts/Locations, Study Status, Study Design and Study Identification
8 February 28, 2024 Contacts/Locations, Oversight and Study Status
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Study NCT05883631
Submitted Date:  May 22, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: CP006
Brief Title: Prospective, Single Arm, Multicenter, Clinical Investigation of the Ablacath™ Mapping Catheter and Ablamap System to Identify and RESOLVE the Source of Atrial Fibrillation and Guide Ablation Therapy. (RESOLVE-AF)
Official Title: Prospective, Single Arm, Multicenter, Clinical Investigation of the Ablacath™ Mapping Catheter and Ablamap System Utilizing the Ablamap® Electrographic FLOW (EGF) to Identify and RESOLVE the Source of Atrial Fibrillation and Guide Ablation Therapy in Paroxysmal or Persistent or Long-standing Persistent Patients.
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2023
Overall Status: Not yet recruiting
Study Start: September 1, 2023
Primary Completion: February 1, 2025 [Anticipated]
Study Completion: September 1, 2025 [Anticipated]
First Submitted: May 22, 2023
First Submitted that
Met QC Criteria:		 May 22, 2023
First Posted: June 1, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 May 22, 2023
Last Update Posted: June 1, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Ablacon, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: To 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, and De Novo or Redo procedures.
Detailed Description: Prospective, single arm, multicenter clinical evaluation in patients with all types of atrial fibrillation in up to 500 subjects in 25 centers globally.
Open or close this module Conditions
Conditions: Atrial Fibrillation
Atrial Fibrillation, Persistent
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Abacath Mapping Catheter/Ablamap System Device: Ablacath™ Mapping Catheter, Ablacath™ Mapping Catheter Accessory Cables, Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software
EGF-Mapping and EGF-Guided Ablation of AF Sources
Open or close this module Outcome Measures
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 ]

SAE composite as adjudicated by a CEC for relatedness to device or procedure
Secondary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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

Exclusion Criteria:

  1. Patient has paroxysmal AF and no prior history of catheter ablation
  2. Atrial fibrillation from a reversible cause (ex. Surgery, hyperthyroidism, sarcoidosis, or pericarditis)
  3. Cardiac surgery or intervention within the past 90 days (ex. Percutaneous Coronary Intervention, transvenous pacing/defibrillation wires, ablation for ventricular arrhythmias, Left Atrial Appendage occlusion devices, Atrial Septal Defect closure devices, Transcatheter Aortic Valve Replacement)
  4. Myocardial infarction within the past 60 days
  5. Severe valvular disease
  6. Contraindication to therapeutic anticoagulation
  7. Decompensated heart failure
  8. Positive pregnancy for female subjects
  9. Any other contraindication to an intra-cardiac mapping and ablation of atrial arrhythmias
  10. Enrollment in another investigational study evaluating another device, biologic or drug
Open or close this module Contacts/Locations
Central Contact Person: Eliza Lawrence
Telephone: 650-933-4490
Email: el@ablacon.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services