Activation Timing and Atrial Fibrillation

NCT02063191 | Terminated

• 1 other identifier: EH13342
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, non-randomized, unblinded study of patients who are followed at Essentia Health - St. Mary's Medical Center and who are referred for a clinically indicated diagnostic electrophysiology (EP) study with or without ablation. During the procedure, events of atrial fibrillation, sinus rhythm and bundle branch block that may occur during the course of the case will be saved electronically and analyzed offline. The stored data will be evaluated off-line for changes in activation timing of the near and far field ventricular signals of the stored events. This proof-of-concept study will attempt to assess whether atrial fibrillation, or bundle branch block can change activation timing compared to baseline sinus rhythm. If no significant activation change is seen, then this finding can be used as a basis to distinguish ventricular tachycardia from atrial fibrillation in future rhythm discrimination methods.

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Bundle Branch Block

Keywords

Atrial Fibrillation; Bundle Branch Block

Outcome Measures

Primary Outcomes (1)

• Activation Timing Shift

  Measurement of activation change in near- and far-field ventricular signal between sinus rhythm and atrial fibrillation and/or bundle branch block.

  During the course of the EP study with all measurements being obtained within 12 hours

Study Arms (2)

Atrial Fibrillation

Patients with atrial fibrillation during the EP study

Bundle Branch Block

Patient with bundle branch block during the course of the EP study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Single center study of patients who are followed at Essentia Health - St. Mary's Medical Center who are referred for a clinically indicated diagnostic EP study with or without ablation.

You may qualify if:

• any patient followed at Essentia Health - St. Mary's Medical Center, Duluth, MN and who is referred for a diagnostic EP study with or without ablation.

You may not qualify if:

• any patient who will undergo an EP study without usual placement of a coronary sinus catheter;
• any patient with permanent (chronic) atrial fibrillation or tachycardia who will not undergo restoration of sinus rhythm during the course of the procedure as a usual part of the procedure;
• any patient who is not willing or unable to provide informed consent.

Sponsors & Collaborators

• Essentia Health: lead

Study Sites (1)

St. Mary's Medical Center

Duluth, Minnesota, 55805, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease

Study Officials

• Michael E Mollerus, MD

  Essentia Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 14, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 4, 2014

Record last verified: 2014-02

Locations

US (1)