Cloud-Based Mapping for Personalized Ablation

Atrial fibrillation is a serious public health issue that affects over 5 million Americans in whom it may cause skipped beats, dizziness, stroke and even death. This study seeks to improve our understanding of the causes of atrial fibrillation and to design new and more effective therapy for this heart rhythm disorder.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

Detailed Description

This project will focus on the development of a novel paradigm for electrophysiologic data analysis and interpretation using cloud-based computing resources and mobile technology. Currently, electrophysiologic data gathered during a procedure is analyzed by the operator using multiple separate desk-based computer systems in the electrophysiology laboratory. The investigators propose that advances in cloud-based computing resources and network connectivity should apply a mobile paradigm to apply to invasive electrophysiologic procedures.

This project will provide proof-of-concept that open-access software the investigators have developed and made available online could be used, via a mobile phone interface, to identify sites in the heart where therapy is effective. At no time will patient therapy be guided by this system. The investigators will pursue therapy using only clinical means. In parallel, a double-blinded team will analyze data in real time using our online software visualized on a smartphone. Only when the case is concluded will the data be unblinded, to determine if the mobile system was accurate in real time.

Thus, development and testing of the cloud-based computing system is designed only to establish feasibility of the paradigm, followed by improvement of computational modeling algorithms. The data that is collected will add to the investigators' existing unique catalogue of multimodal (structural, clinical, and electrophysiologic) data.

The importance of this novel paradigm is to move from analyzing large volumes of data in isolation to creating a mobile platform, and to allow scalability to increase access, such as to underdeveloped medical centers.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be men and women of any ethnicity aged 21-80 years undergoing ablation at Stanford of AF. Patients will have failed or be intolerant of ≥ 1 anti-arrhythmic drug or not willing to accept antiarrhythmic drug therapy. 50 patients will be enrolled at Stanford University over 1-2 years.

Description

Inclusion Criteria:

• men and women of any ethnicity
• aged 21-80 years
• undergoing ablation of atrial fibrillation at Stanford University
• failed or be intolerant of ≥ 1 anti-arrhythmic drug or not willing to accept antiarrhythmic drug therapy.

Exclusion Criteria:

• active coronary ischemia or decompensated heart failure
• atrial or ventricular clot on trans-esophageal echocardiography
• pregnancy (to minimize fluoroscopic exposure)
• inability or unwillingness to provide informed consent
• rheumatic valve disease (because it results in a unique AF phenotype)
• thrombotic disease or venous filters
• significantly reduced kidney function

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mapping Accuracy	Location of driver regions for AF	During Procedure (Electrophysiology Study and Ablation)
Termination of atrial fibrillation	Does ablation at any driver region lead to AF termination	During Procedure (Electrophysiology Study and Ablation)

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: ablation; arrhythmia; cardiac electrophysiology
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 49800 (Other Identifier: Stanford IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No