RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing E… (NCT05883631) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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.
United States400 participantsStarted 2023-10-23
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
âś“. Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia
âś“. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law
✓. 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
âś•. De Novo paroxysmal AF
âś•. AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
âś•. 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)
âś•. Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
âś•. Myocardial infarction within the past 90 days
What they're measuring
1
Number of participants with 12-month freedom from AF recurrence (with or without AADs)
Timeframe: From 90 days to 12 months after index procedure
2
Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure
Timeframe: From index procedure to 7 days after index procedure
3
Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome