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Screening for Atrial Fibrillation in Pulmonary Embolism Study -SAFE-PE Study

NCT03274401 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-07-28

No results posted yet for this study

Summary

Patients with newly diagnosed pulmonary embolism and high thromboembolic risk will be randomized to screening for atrial fibrillation or standard of care using intermittent ECG registration for at least two weeks.

Conditions

Interventions

DEVICE

Zenicor intermittent ECG device

At least two weeks of screening twice daily for atrial fibrillation using intermittent ECG recordings, and prolonged use of OAC-therapy if atrial fibrillation is detected

DEVICE

5 day ECG patch

Selection of device for monitoring clinicians' choice

Sponsors & Collaborators

Principal Investigators

  • Håkan Wallén, MD PhD · Karolinska Institutet - Danderyd Hospital

  • Emma Svennberg, MD PhD · Karolinska Institutet - Danderyd Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-13
Primary Completion
2020-12-31
Completion
2022-04-01

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03274401 on ClinicalTrials.gov