We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 259383 for:    ALL
Previous Study | Return to List | Next Study

Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion (PRE-ELECTRIC)

This study is currently recruiting participants.
Verified November 2017 by Vestre Viken Hospital Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT03346863
First Posted: November 17, 2017
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Oslo University Hospital
Lund University
Information provided by (Responsible Party):
Vestre Viken Hospital Trust
  Purpose

In patients with persistent atrial fibrillation (AF), electrical cardioversion is very effective in restoring sinus rhythm if modern, biphasic cardioverters are used. However, approximately 50 per cent of the successfully cardioverted patients experience a recurrence of AF within a few weeks. Therefore, valid predictors for AF recurrence would be of great clinical relevance, to avoid unnecessary procedures.

In the PRE-ELECTRIC study, we will investigate the predictive value of potential new biomarkers with respect to AF recurrence within 30 days after electrical cardioversion. We will investigate serum and plasma biomarkers, electrocardiological markers and echocardiographic variables in this respect. The study will be undertaken as a prospective cohort study at Bærum Hospital, Vestre Viken Hospital Trust, with national and international collaborators.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion

Resource links provided by NLM:


Further study details as provided by Vestre Viken Hospital Trust:

Primary Outcome Measures:
  • Atrial fibrillation recurrence [ Time Frame: 30 days after electrical cardioversion ]
    ECG-documented atrial fibrillation recurrence after successful cardioversion


Biospecimen Retention:   Samples With DNA
Serum, EDTA Plasma, Citrated Plasma, EDTA Whole Blood

Estimated Enrollment: 270
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients > 18 years referred for electrical cardioversion for ECG-documented persistent atrial fibrillation.
Criteria

Inclusion Criteria:

  • Patients > 18 years referred for electrical cardioversion for persistent atrial fibrillation
  • Signed, informed consent

Exclusion Criteria:

  • Patients < 18 years
  • Patients with paroxysmal atrial fibrillation
  • Patients unwilling to participate or without consent competence
  Contacts and Locations
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): NCT03346863


Contacts
Contact: Arnljot Tveit, MD, PhD 0047-97171773 arnljot.tveit@vestreviken.no
Contact: Mona Olufsen, RN 0047-90637441 mona.olufsen@vestreviken.no

Locations
Norway
Bærum Hospital, Vestre Viken Recruiting
Sandvika, Bærum, Norway, 1346
Contact: Arnljot Tveit, MD, PhD    0047-97171773    arnljot.tveit@vestreviken.no   
Contact: Mona Olufsen, RN    0047-90637441    mona.olufsen@vestreviken.no   
Sponsors and Collaborators
Vestre Viken Hospital Trust
Oslo University Hospital
Lund University
  More Information

Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT03346863     History of Changes
Other Study ID Numbers: PRE-ELECTRIC 2017/1604
First Submitted: November 14, 2017
First Posted: November 17, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vestre Viken Hospital Trust:
Electrical Cardioversion

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes