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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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are joining this clinical trial?

"Ablacon, Inc., the sponsor of this clinical trial, seeks 400 patients to meet the study's inclusion criteria. The medical trial will be conducted at multiple sites, such as Piedmont Health in Athens, Georgia and University of Utah in Salt Lake City, Utah."

Answered by AI

Is there still capacity for new participants in this clinical trial?

"As evidenced on clinicaltrials.gov, this ongoing medical investigation is actively recruiting patients for participation. The initial advertisement was posted on October 23rd 2023 with the most recent update taking place November 29th of that same year."

Answered by AI

Is my eligibility for this experiment adequate to join it?

"Prerequisites for this clinical trial include atrial fibrillation and age between 18 to 80. There is room for up to 400 participants in the research study."

Answered by AI

Does this research trial accept participants who are over fifty years old?

"Eligibility for this trial is limited to those 18 years of age or older and no more than 80."

Answered by AI

Are there multiple locations in the US that have commenced this research project?

"This research is taking place across 5 locations - two of which are Athens, Salt Lake City and Charlottesville. Selecting the closest site to your residence is recommended in order to curtail travel needs if you decide to join this trial."

Answered by AI

Who else is applying?

What site did they apply to?
Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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.
2023. "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.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05883631.
All > Afib > Atrial Fibrillation
~259 spots leftby Mar 2025
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