Clinical trial NCT05883631: 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: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Fibrillation, Persistent
Atrial Fibrillation Paroxysmal
Arrhythmia
Arrhythmias, Cardiac
Atrial Flutter
Atrial Fibrillation, Paroxysmal or Persistent
Atrial Arrhythmia
Atrial Tachycardia
Lead sponsor: Cortex
Sponsor class: INDUSTRY
Collaborators: name: Ablacon, Inc.
First posted: 2023-06-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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
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

Primary outcomes:
measure: Number of participants with 12-month freedom from AF recurrence (with or without AADs)
timeFrame: From 90 days to 12 months after index procedure
measure: 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
measure: Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure
timeFrame: From index procedure to 30 days after index procedure
measure: Overall reduction in burden of AF for subset of patients with implantable loop recorder
timeFrame: From 90 days to 12 months after index procedure
measure: Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time
timeFrame: Index or Repeat Procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Banner Health
state: Arizona
city: Redwood City
country: United States
facility: Sutter Health Sequoia Heart and Vascular Institute
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Golden
country: United States
facility: Colorado Heart
state: Colorado
city: Fort Lauderdale
country: United States
facility: Florida Heart Rhythm Specialists
state: Florida
city: Jacksonville
country: United States
facility: Ascension Medical Group
state: Florida
city: Athens
country: United States
facility: Piedmont Health
state: Georgia
city: Royal Oak
country: United States
facility: Beaumont Health
state: Michigan
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Health
state: Virginia
city: Bellevue
country: United States
facility: Evergreen Health Research/Overlake Medical Center
state: Washington
city: Aalst
country: Belgium
facility: OLV Hospital Aalst
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Genk
country: Belgium
facility: ZOL
city: Brno
country: Czechia
facility: Neuron Medical
city: Praha
country: Czechia
facility: IKEM (Institute for Clinical and Experimental Medicine)
city: Praha
country: Czechia
facility: Na Homolce Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC (location AMC)
state: North-Holland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Piedmont Athens Regional
name: Kent Nilsson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Lucas Boersma, Prof. MD.
role: PRINCIPAL_INVESTIGATOR
References: