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Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial Fibrillation (OPTIMA)

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ClinicalTrials.gov Identifier: NCT04101539
Recruitment Status : Active, not recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

Catheter ablation is an established cornerstone of therapy for patients with symptomatic atrial fibrillation (AF) who wish to avoid anti-arrhythmic drug therapy or for whom anti-arrhythmics have proven ineffective. Pulmonary vein isolation (PVI), in which circumferential ablation is performed around the ostia of the pulmonary vein - left atrial junctions, is the standard ablation approach internationally. Single-procedure success rates (1y, freedom from AF, off anti-arrhythmics) for patients with paroxysmal AF is roughly 70%, and even worse (roughly 50%) for patients with persistent AF.

A number of strategies have been developed to improve outcomes in patients undergoing AF ablation, particularly in patients with persistent AF. Unfortunately, large prospective randomized trials (including STAR-AF II, published in NEJM in 2015) have demonstrated a failure of ancillary ablation techniques to improve AF ablation outcomes relative to PVI alone.

In a collaborative effort between the Cardiology electrophysiology group and the Trayanova laboratory (Biomechanical Engineering), investigators have developed a strategy of patient-specific modeling to identify pro-arrhythmic sites in AF patients that may be amenable to ablation. In this approach, patients undergo a pre-ablation cardiac MRI with late gadolinium enhancement, to delineate regions of healthy atrial tissue and regions of scar (this scan is clinically indicated, and performed currently in patients undergoing PVI for AF). A novel in silico modeling to determine regions supporting electrical reentry in the atrium, driving ongoing AF, has been developed by the Trayanova lab. In preliminary studies, investigators have demonstrated the ability to identify and target these regions with catheter ablation in patients undergoing PVI.

Investigators would like to conduct a prospective, randomized clinical trial in patients undergoing ablation for symptomatic persistent AF. All patients enrolled would undergo standard pre-procedure imaging (LGE-MRI) prior to the day of procedure. Investigators have developed methodology termed OPTIMA (OPtimal Target Identification via Modeling of Arrhythmogenesis) to determine, based on non-invasive patient-specific anatomic and tissue data from late gadolinium enhancement cardiac MRI (LGE-CMR) and simulation of cardiac electrical function, personalized ablation targets for persistent AF in patients with fibrotic remodeling.. Patients would be randomized to receiving PVI only versus PVI + OPTIMA ablation at the time of ablation. Patients would then be followed in standard clinical fashion at 3m, 6m, and 12m to assess for ablation efficacy and for procedural complications.

Investigators postulate a 20% improvement in freedom from AF with PVI + OPTIMA ablation form 50% to 70% (compared to PVI alone), investigators anticipate that in 1:1 randomization, a sample size of 80 patients in each arm will yield a power calculation of 80% with an alpha of 0.05. Investigators anticipate that enrollment and 1y clinical follow-up for 160 patients (total) undergoing AF ablation will require a 4y timeline.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Chronic Device: OPTIMA-guided catheter ablation Device: Standard PVI Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, controlled
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Blinding of patient and outcomes assessor to ablation protocol.
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial Fibrillation
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Ablation (PVI)
Patients in this arm will receive standard ablation for atrial fibrillation (wide-area circumferential ablation to achieve pulmonary vein isolation [PVI]).
Device: Standard PVI
Standard PVI for AF.

Experimental: OPTIMA Ablation
Patients in this arm will receive standard PVI ablation and supplemental ablation of reentrant driver sites identified by OPTIMA analysis as sites likely supportive of persistent atrial fibrillation.
Device: OPTIMA-guided catheter ablation
Patients in the experimental arm will undergo supplemental ablation of OPTIMA-identified sites hypothesized to support/perpetuate chronic atrial fibrillation.




Primary Outcome Measures :
  1. Freedom from atrial arrhythmias (>30s) [ Time Frame: 1 year ]
    Freedom from recurrent Atrial fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (> 30s) after 90 day blanking period. This will be measured as the percentage of the study population that is free from atrial arrhythmias during the 1y follow-up period.


Secondary Outcome Measures :
  1. Change in AF burden [ Time Frame: 1 year ]
    This will measure the change in percentage time spent in AF for each study patient after ablation (baseline is the pre-ablation percentage time in AF). The change in AF burden for the overall study population will be calculated and expressed.

  2. Percent participants with 70% or more reduction in AF burden [ Time Frame: 1 year ]
    This will be a measure of the number of patients in each study group that achieve at least a 70% reduction in their baseline AF burden. This outcome will be expressed as a percentage of the number of patients in each study group meeting this outcome.

  3. Freedom from major complications [ Time Frame: 1 year ]
    This is a comparison of the percentage of patients in each study arm suffering a major complication. Complications including the following: death, stroke, cardiac tamponade, atrial-esophageal fistula, vascular injury, hemorrhage, cardiac injury, myocardial infarction, or other major complications resulting in either reparative procedure or prolonged hospitalization. Outcome will be expressed as a ratio.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients must be at least 18 years old at the time of enrollment.
  • Patient was referred to Johns Hopkins cardiac electrophysiology division for clinically indicated catheter ablation for persistent or long standing persistent AF either for index ablation or redo ablation.
  • Patient is currently on systemic anticoagulation or has no contraindication to initiate systemic anticoagulation.
  • Capable of undergoing informed consent.
  • A Pre-Op cardiac MRI including LGE in sinus rhythm must be performed prior to ablation and patient should be capable of undergoing cardioversion and cardiac MRI.
  • MRI scan should show evidence of left atrial scarring.

Exclusion Criteria:

  • Patient is not a suitable candidate for AF ablation.
  • Patient is currently not on anticoagulation and has significant contraindications to initiate systemic anticoagulation.
  • Pregnant women may not participate in the study because gadolinium MRI contrast is contraindicated in pregnancy.
  • Patient with Body weight more than 300 lbs as they cannot undergo MRI scans.
  • Patients with Glomerular Filtration Rate (GFR) < 30 mL/min should not be enrolled in the study due to the use of intravenous gadolinium as an MRI contrast agent.
  • No evidence of Left Arial fibrosis in MRI scan as these images are not suitable for simulation.
  • Inability to get MRI in sinus rhythm.
  • Long standing persistent AF more than 3 years of duration.
  • Prior surgical maze procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101539


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: David Spragg, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04101539     History of Changes
Other Study ID Numbers: IRB00183327
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Deidentified patient data may be shared among study team members.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Johns Hopkins University:
catheter ablation; atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes