New-onset Atrial Fibrillation and Flutter Following Cardiac Surgery

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 08-005799
    Sponsor Protocol Number: 08-005799

About this study

The aims of this investigation are:

To assess the predictive value (and accuracy) of clinical and physiologic preoperative variables in identifying patients at risk for the development of new-onset atrial arrhythmia after cardiac surgery.

To assess the feasibility of a physiological risk model based on clinical and echocardiographic indexes to predict post-operative AF.

To assess the role of prophylactic agents in the prevention of new-onset postoperative POAF

To assess the economic impact of new-onset postoperative AF:

  • Length of hospital stay (will be measured as fractions of days)

  • Hospital cost (will be measured in standardized dollars)

  • Resource utilization (will be measured by resource-based relative-value units)

To assess the outcome of patients who develop early atrial fibrillation following cardiac surgery:

  • To assess whether first time new-onset POAF predicts long-term AF.

  • Examine the predictive value of potential preoperative variables in identifying patients at risk of developing

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion criteria:

  • This will be historical cohort study of all patients above the age of 18 with preoperative sinus rhythm who underwent cardiac surgery, including Transcatheter Aortic Valve Replacement (TAVR) at the Mayo Clinic between 1990 and 2013.

    Exclusion criteria:

    • Patients who have denied research access to their medical records will not be included in the study (Minnesota state law [Minn Stat 144.335 subd. 3a (d)]).Since the study involves minimal risk to the patients, we will request waiver of informed consent and use HIPAA authorization.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rowlens Melduni, M.D., M.P.H.

Closed for enrollment

Contact information:

Rowlens Melduni M.D., M.P.H.

(507)284-9601

Melduni.Rowlens@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20315008

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