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NCT05883631 · ClinicalTrials.gov registry record · NA

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.

A NA study of Atrial Fibrillation and Atrial Flutter, sponsored by Cortex.

Active
Registry status
NA
Development phase
400
Enrollment target
20
Study locations

NCT05883631 is a NA study of Atrial Fibrillation and Atrial Flutter that is active but no longer recruiting, run by Cortex. The registered enrollment target is 400 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT05883631, a NA study of Atrial Fibrillation and Atrial Flutter, is active but no longer recruiting, sponsored by Cortex.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
400 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac Arrhythmia Atrial Fibrillation Paroxysmal Atrial Arrhythmia Atrial Tachycardia Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal or Persistent

Interventions

  • DEVICE Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation
  • DEVICE Electrographic Flow (EGF) mapping (no ablation)

Study Locations (20)

Other

  • OLV Hospital Aalst - Aalst
  • ZNA Middelheim - Antwerp
  • ZOL - Genk
  • Neuron Medical - Brno
  • IKEM (Institute for Clinical and Experimental Medicine) - Prague

Alabama

  • University of Alabama - Birmingham
  • Grandview Medical Center - Birmingham

California

  • Sutter Health Sequoia Heart and Vascular Institute - Redwood City
  • Pacific Heart Institute - Santa Monica

Florida

  • Florida Heart Rhythm Specialists - Fort Lauderdale
  • Ascension Medical Group - Jacksonville

Virginia

  • University of Virginia - Charlottesville
  • Inova Health - Falls Church

Arizona

  • Banner Health - Phoenix

Colorado

  • Colorado Heart - Golden

Georgia

  • Piedmont Health - Athens

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2023-10-23
Est. Completion 2026-01
Phase NA

Sponsor

Cortex

1 total trials

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What the Registry Record Tells You About NCT05883631

The ClinicalTrials.gov registry entry for NCT05883631 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (87% lower). The listed sponsor is Cortex, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation is the first listed.

NCT05883631 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT05883631 about?

NCT05883631 is a clinical study titled "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.". 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 pro...

What is the current status of trial NCT05883631?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2023-10-23. Estimated completion is 2026-01.

What conditions does trial NCT05883631 study?

This clinical trial studies the following conditions: Atrial Fibrillation, Atrial Flutter, Arrhythmias, Cardiac, Arrhythmia, Atrial Fibrillation Paroxysmal.

What interventions are being tested in trial NCT05883631?

The interventions under investigation include: Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation (DEVICE), Electrographic Flow (EGF) mapping (no ablation) (DEVICE).

Who is sponsoring clinical trial NCT05883631?

This trial is sponsored by Cortex, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05883631 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.