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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: Active NA study of Atrial Fibrillation and Atrial Flutter, sponsored by Cortex.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2023-10-23 |
| Est. Completion | 2026-01 |
| Phase | NA |
What the registry record for NCT05883631 still lists
NCT05883631 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (87% lower).
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 names 20 study sites across 12 states, led by 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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Where NCT05883631's enrollment target sits among peer trials
400 69th of 202 higher than 132 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
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