NCT02657590

Brief Summary

This study aims at recording cardiac arrhythmias in patients after open heart surgery. The arrhythmias will be monitored during the entire first postoperative period, till six weeks after surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

January 14, 2016

Last Update Submit

March 16, 2016

Conditions

Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (1)

  • Arrhythmia

    Documention of arrhythmias in patients after open heart surgery during the six (6) weeks after release

    6 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients aged 18 and over who underwent open-heart surgery.

You may qualify if:

  • years or older.
  • Patients after open-heart surgery (any type of surgery).

You may not qualify if:

  • Patients with internal pacemaker.
  • patients with known basic arrhythmia (pre-surgery) or patients who are discharged with some arrhythmias.
  • Patients with low response which it is expected that there will not be able to use the monitoring device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ziv Becerman, MD

    Rambam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziv Becerman, MD

CONTACT

97247772631z_beckerman@rambam.health.gov.il

Daniel Haber, MA

CONTACT

972-4-7772048d_haber@rambam.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
cardiac surgeon

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 18, 2016

Study Start

March 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2019

Last Updated

March 17, 2016

Record last verified: 2016-03