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ACTIVE NOT RECRUITING 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.

NCT05883631 · View on ClinicalTrials.gov ↗

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.

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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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05883631

The ClinicalTrials.gov registry entry for NCT05883631 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cortex, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05883631 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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 Arrhythmia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05883631?

This trial is sponsored by Cortex, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial