CABG REVEAL: Atrial Fibrillation After Coronary Artery Bypass Graft

NCT02169622 | Completed

• 1 other identifier: STH12-009
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial Fibrillation is an abnormal heart rhythm that can occur after coronary heart bypass graft operations. How often this happens and what other problems occur for a person after these operations needs to be better understood. This study uses a device called the Reveal XT, a small device that records heart rhythms to track a patient's heart rhythms after the bypass surgery. The device is implanted at the time the bypass graft is made. The information that is gathered for this study will help physicians to provide better treatment and follow-up of the patients under their care.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Number and cost of atrial fibrillation after coronary artery bypass grafting (CABG) per patient

  Patient follow up

  Three year follow-up

• Number of complication s related to atrial fibrillation in patients after CABG

  Patient follow up

  3 year follow up

• Number of therapeutic/intervention changes for participants post CABG resulting from use

  Patient follow up

  3 year follow up

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 60 years of age or older undergoing coronary artery bypass grafting (CABG).

You may qualify if:

• years of age or older
• Presenting for elective Coronary Artery Bypass Graft at Saint Thomas West Hospital

You may not qualify if:

• Patients \<60 years of age
• Prior cardiac surgery
• Emergent surgery
• Need for concomitant cardiac surgery other than PFO closure
• Prior history of AF or Atrial flutter
• Prior atrial ablation
• Prior cardioversion
• Patients with prior permanent pacemaker
• Ejection fraction \<35%
• Prior history of thyroid disease
• Prior history of a cardiomyopathy
• Patients without telephonic access

Sponsors & Collaborators

• Saint Thomas Health: lead

Study Sites (1)

Saint Thomas West Hospital

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Evelio Rodriquez, MD

  Saint Thomas Heart at Saint Thomas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 23, 2014
• Study Start: June 18, 2013
• Primary Completion: June 12, 2017
• Study Completion: September 1, 2020
• Last Updated: November 6, 2020

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)