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Procedure

EGF Mapping and Ablation Therapy for Atrial Fibrillation (RESOLVE-AF Trial)

N/A
Recruiting
Led By David Haines, MD
Research Sponsored by Ablacon, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

RESOLVE-AF Trial Summary

This trial will test the safety and effectiveness of a system for mapping and treating types of atrial fibrillation. It will also measure how well it predicts outcomes.

Who is the study for?
This trial is for adults who can legally consent and are suitable candidates for heart mapping and ablation therapy to treat various types of atrial arrhythmias, including different forms of atrial fibrillation, flutter, and tachycardia.Check my eligibility
What is being tested?
The trial tests the Ablacath™ Mapping Catheter and Ablamap® System's safety and effectiveness in creating Electrographic Flow (EGF) maps to guide treatment for all types of atrial fibrillation during initial or repeat procedures.See study design
What are the potential side effects?
Potential side effects may include discomfort at the catheter insertion site, bleeding or bruising, irregular heartbeats post-procedure, infection risk at the entry point, or rare complications related to heart mapping and ablation.

RESOLVE-AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old or of legal age to consent where I live.

RESOLVE-AF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Demonstrate the predictive value of EGF phenotype for ablation outcome
Freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure
Freedom from documented AF episodes lasting > 30 seconds (with or without AAD) following the index procedure through 12-months
Secondary outcome measures
Freedom from a composite of SAE occurring within 30 days from post-index ablation procedure
Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time
Overall reduction in burden of AF for subset of patients with implantable loop recorder

RESOLVE-AF Trial Design

2Treatment groups
Experimental Treatment
Group I: Redo Subjects: Ablacath Mapping Catheter/Ablamap SystemExperimental Treatment1 Intervention
Group II: De Novo Subjects: Ablacath Mapping Catheter/Ablamap SystemExperimental Treatment1 Intervention

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Who is running the clinical trial?

Ablacon, Inc.Lead Sponsor
3 Previous Clinical Trials
195 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
195 Patients Enrolled for Atrial Fibrillation
David Haines, MDPrincipal InvestigatorBeaumont Health
2 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
41 Patients Enrolled for Atrial Fibrillation
Kent Nilsson, MDPrincipal InvestigatorPiedmont Athens Regional
~212 spots leftby Mar 2025
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