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Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients (SAFE-ME)

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ClinicalTrials.gov Identifier: NCT03357926
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:

Atrial fibrillation (AF) is associated with a five-fold increased risk of cerebrovascular stroke. While the risk of stroke in patients with known AF can be calculated via AF stroke prediction risk scores, the prediction of AF occurrence per se in individual patients remains difficult.

We will recruit 250 patients with an implanted dual-chamber Pacemaker (PM) or an implantable cardioverter Defibrillator (ICD) with atrial lead to ensure continuous rhythm monitoring during follow up. At baseline, we will gather clinical and device data of patients. For AF prediction based on surface Electrocardiography (ECG), 24-h Holter ECG monitoring will be performed. After 6 months, we will assess the occurrence of AF during the study period via interrogation of PM/ICD. The resulting data will be used to develop algorithms including clinical, device and ECG data for prediction of the development of AF in individual patients. If possible, we will develop a risk score of high accuracy by combination of demographical, clinical and technical parameters of device patients. The resulting risk score could potentially help to facilitate the decision if anticoagulation is necessary in patients with either risk of AF or embolic stroke of unknown origin. Furthermore, Hayn et al. (AIT Austrian Institute of Technology) are currently developing algorithms to predict the occurrence of AF surface ECG data. It is an additional aim of this project to support the development of this algorithm in pacemaker and ICD patients and to increase the accuracy of AF prediction with clinical parameters and other parameters available to patients with implanted pacemaker (PM) or implanted cardioverter-defibrillator (ICD).


Condition or disease Intervention/treatment
Atrial Fibrillation Pacemaker Ddd ICD Diagnostic Test: 24 hour Holter ECG Monitoring

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SAFE-ME - Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observation Group Diagnostic Test: 24 hour Holter ECG Monitoring
24 hour Holter ECG Monitoring




Primary Outcome Measures :
  1. Frequency of occurrence of atrial high rate episodes [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with an implanted dual-chamber Pacemaker or an implantable cardioverter Defibrillator
Criteria

Inclusion Criteria:

  • Implanted pacemaker or implanted cardioverter defibrillator (ICD) with atrial lead
  • CHADS-VASc Score of 2 or more
  • Sinus rhythm or atrial paced rhythm
  • Atrial stimulation rate 50% or less
  • ModeSwitch rate 50% or less since last pacemaker interrogation

Exclusion Criteria:

  • pacemaker or ICD malfunction
  • atrial fibrillation (AF) at time of pacemaker / ICD interrogation
  • AF during 24-hour Holter ECG monitoring
  • permanent AF

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357926


Contacts
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Contact: Daniel Scherr, Assoc.Prof. PD Dr. +4331638512544 daniel.scherr@medunigraz.at

Locations
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Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Daniel Scherr, Assoc.Prof. PD Dr.         
Sponsors and Collaborators
Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03357926    
Other Study ID Numbers: 29-229 ex 16/17
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes