OPTIMA Ablation for Atrial Fibrillation

Phase-Based Progress Estimates
Johns Hopkins Hospital, Baltimore, MDAtrial FibrillationOPTIMA-guided catheter ablation - Device
All Sexes
What conditions do you have?

Study Summary

This trial is a prospective, randomized clinical trial in patients undergoing ablation for symptomatic persistent AF to assess whether adding OPTIMA ablation to PVI improves freedom from AF.

Eligible Conditions
  • Chronic Atrial Fibrillation

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 1 year

1 year
Change in AF burden
Freedom from atrial arrhythmias (>30s)
Freedom from major complications
Percent participants with 70% or more reduction in AF burden

Trial Safety

Trial Design

2 Treatment Groups

Standard Ablation (PVI)
1 of 2
OPTIMA Ablation
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: OPTIMA Ablation · No Placebo Group · N/A

OPTIMA Ablation
Experimental Group · 1 Intervention: OPTIMA-guided catheter ablation · Intervention Types: Device
Standard Ablation (PVI)
ActiveComparator Group · 1 Intervention: Standard PVI · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,093 Previous Clinical Trials
31,767,529 Total Patients Enrolled
9 Trials studying Atrial Fibrillation
1,999 Patients Enrolled for Atrial Fibrillation
David Spragg, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
160 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
160 Patients Enrolled for Atrial Fibrillation

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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Frequently Asked Questions

To what extent is the sample size being utilized in this medical study?

"Indeed, clinicaltrials.gov displays that this study is currently enrolling volunteers. This trial was published on September 1st 2019 and has been revised as recently as 9/26/2022. 200 individuals across one medical site are required to fulfill the enrolment goals of this research project." - Anonymous Online Contributor

Unverified Answer

Are there any openings for participants in this trial currently?

"According to clinicaltrials.gov, this trial is in need of participants and has been since September 1st 2019. The study was most recently updated on the 26th of September 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.