Examining the impact of STAR Apollo Mapping System on Atrial Fibrillation ablation outcomes
Observational Study to Examine the Procedural and Outcomes of AF Ablation Assisted by STAR Apollo™ Mapping System
This study is testing whether a new mapping system can help improve the success of heart procedures for people with persistent atrial fibrillation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Kansas City Heart Rhythm Research Foundation Academic / other |
| Locations | 4 sites (Jonesboro, Arkansas and 3 other locations) |
| Trial ID | NCT05826665 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of the STAR Apollo Mapping System in improving procedural and acute outcomes for patients undergoing catheter ablation for persistent atrial fibrillation (AF). The STAR Apollo system provides detailed analysis of electrical signals during the ablation procedure, helping physicians identify areas responsible for sustaining AF. By focusing on patients who have previously undergone pulmonary vein isolation, the study aims to gather data from multiple centers to assess the potential benefits of this advanced mapping technology. The goal is to enhance the success rate of AF ablation beyond the current 50% achieved with traditional methods.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with persistent AF lasting more than 7 days but less than 2 years, who have previously undergone pulmonary vein isolation and experienced AF recurrence.
Not a fit: Patients with longstanding persistent AF, significant heart conditions, or contraindications to anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients with persistent atrial fibrillation undergoing ablation procedures.
How similar studies have performed: While the STAR Apollo Mapping System represents a novel approach, previous studies have not significantly improved outcomes beyond traditional methods, making this an important area of investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indication for ablation of persistent AF * Age \>18 years * Persistent AF \>7 days and total continuous duration \<2 years * Patients have previously undergone pulmonary vein isolation, using any technique and have had AF recurrence. * Patients have limited additional ablation at their first procedure (e.g. right atrial flutter line). Exclusion Criteria: * Patients with previous ablation in more than one region of the left atrium in addition to the pulmonary veins. * Patients with longstanding persistent AF (continuous duration \>2 years) or significant substrate (mitral valve disease, scarring, very dilated atria \>50mm). * Creatinine clearance estimated glomerular filtration rate (eGFR) \<30mls/min * Contraindication to anticoagulation
Where this trial is running
Jonesboro, Arkansas and 3 other locations
- St.Bernards Medical Center — Jonesboro, Arkansas, United States (Not_yet_recruiting)
- Sarasota Medical Center — Sarasota, Florida, United States (Recruiting)
- Kansas City Heart Rhythm Institute - Roe Clinic — Overland Park, Kansas, United States (Not_yet_recruiting)
- Overland Park Regional Medical Center — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Dhanunjaya Lakkireddy, MD — Kansas City Heart Rhythm Institute
- Study coordinator: Donita Atkins
- Email: datkins@kchrf.com
- Phone: 816-651-1969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.