RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Atrial Fibrillation Sources and Guide Ablation Therapy.

• Sponsor: Ablacon, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05883631
• Collaborator: (none)
• Enrollment: 500
• Arm: 1
• Anticipated Duration (Months): 24

Study Details

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.

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: Ablacath™ Mapping Catheter, Ablacath™ Mapping Catheter Accessory Cables, Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software	N/A

Detailed Description

Subjects with all types of AF who are candidates for catheter ablation of their AF. The study will enroll up to 500 subjects in 25 centers globally.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: N/A
• 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 Atrial Fibrillation Sources and Guide Ablation Therapy.
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

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 [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 [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 [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 [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 [12 months]

   Evaluation of patient freedom from AF

3. Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time [Index or Repeat Procedure]

   Evaluation of index or repeat procedure times

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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, etc.)

3. 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)

4. Presence of transvenous pacing or defibrillator leads

5. Myocardial infarction within the past 90 days

6. LA diameter >6.5 cm

7. LVEF < 35%

8. Severe valvular disease or prosthetic valve

9. Contraindication to therapeutic anticoagulation

10. Decompensated heart failure

11. Positive pregnancy

12. Any other contraindication to an intra-cardiac mapping and ablation of atrial arrhythmias

13. Enrollment in another investigational study evaluating another device, biologic or drug

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ablacon, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ablacon, Inc.
• ClinicalTrials.gov Identifier: NCT05883631
• Other Study ID Numbers: CP006
• First Posted: Jun 1, 2023
• Last Update Posted: Jun 2, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• 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: Atrial Fibrillation; Arrhythmias, Cardiac; Tachycardia; Atrial Flutter

Study Results

No Results Posted as of Jun 2, 2023