Cloud-Based Mapping for Personalized Ablation

NCT04127123 | Withdrawn

• 1 other identifier: 49800
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Keywords

arrhythmia; cardiac electrophysiology; ablation

Outcome Measures

Primary Outcomes (2)

• 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)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanjiv Narayan, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: October 15, 2019
• Study Start: July 3, 2019
• Primary Completion: December 30, 2020
• Study Completion: January 11, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

US (1)