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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 Cortex

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 index or repeat procedure

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from index procedure to 7 days after index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from index procedure to 7 days after index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and from index procedure to 7 days after index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with 12-month freedom from AF recurrence (with or without AADs)

Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure

Secondary study objectives

Number of participants with 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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Redo Arm: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sourcesExperimental Treatment1 Intervention

Subjects with paroxysmal, persistent or long-standing persistent atrial fibrillation (AF) coming in for a redo AF procedure.

Group II: Recurrence: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sourcesExperimental Treatment1 Intervention

Subjects from the De Novo or Redo Arm in which symptomatic atrial fibrillation (AF) recurrence occurs at any time after the 90-day blanking period are eligible for a "recurrence procedure". This procedure follows the same workflow as the "Redo arm".

Group III: De Novo Arm: Electrographic Flow (EGF) mappingExperimental Treatment1 Intervention

Subjects with persistent or long-standing persistent atrial fibrillation (AF), coming in for a De Novo pulmonary vein isolation procedure.

0 / 1Eligibility criteria met