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.

Not Applicable

Active, not recruiting

• Conditions: Arrhythmia; Atrial Fibrillation, Persistent; Atrial Fibrillation Paroxysmal; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Tachycardia; Atrial Flutter; Atrial Fibrillation, Paroxysmal or Persistent; Atrial Arrhythmia

• Registration Number: NCT05883631
• Lead Sponsor: Cortex

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 Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-01
• Study Start: 2023-10-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants with 12-month freedom from AF recurrence (with or without AADs)	From 90 days to 12 months after index procedure	This measure represents the number of subjects with freedom from documented episodes of atrial fibrillation (AF) recurrence lasting longer than 30 seconds from the 90-day post-procedure blanking period through 12 months of follow-up (with or without AADs).
Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure	From index procedure to 7 days after index procedure	Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure
Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome	12 months

Secondary Outcome Measures

Name	Time	Method
Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure	From index procedure to 30 days after index procedure	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	From 90 days to 12 months after index procedure	Evaluation of patient's freedom from AF based on recordings of implantable loop recorders
Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time	Index or Repeat Procedure	Evaluation of index or recurrence procedure data

Trial Locations

Locations (24)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Grandview Medical Center; 🇺🇸 Birmingham, Alabama, United States

Banner Health; 🇺🇸 Phoenix, Arizona, United States

Sutter Health Sequoia Heart and Vascular Institute; 🇺🇸 Redwood City, California, United States

Pacific Heart Institute; 🇺🇸 Santa Monica, California, United States

Colorado Heart; 🇺🇸 Golden, Colorado, United States

Florida Heart Rhythm Specialists; 🇺🇸 Fort Lauderdale, Florida, United States

Ascension Medical Group; 🇺🇸 Jacksonville, Florida, United States

Piedmont Health; 🇺🇸 Athens, Georgia, United States

Beaumont Health; 🇺🇸 Royal Oak, Michigan, United States

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