Risk Profile for Atrial Fibrillation
Identification of a Risk Profile in Patients With Atrial Fibrillation
1 other identifier
observational
503
1 country
1
Brief Summary
The objective of this study is to assess the risk profile in patients with atrial fibrillation, which represents the degree of changes (remodeling) in the atrial tissue and which can help to predict in which patients rhythm control will be successful. This risk profile will consist of a combination of underlying (heart) disease and risk factors, as measured with use of parameters obtained with echocardiography, circulating biomarkers and other relevant clinical data. Ultimately this risk profile can be used to guide type of (rhythm) control therapy in individual patients with atrial fibrillation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
January 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJuly 28, 2015
July 1, 2015
3.5 years
January 1, 2012
July 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
assess the risk profile associated with success of rhythm control therapy at follow-up.
1\) \< 1 second AF on end-of-study ECG; (2) \< 30 seconds AF on end-of-study 48-hour Holter recording
12 months
Secondary Outcomes (10)
Time to recurrence of (a)symptomatic AF;
1+12+60 months
Failure of rhythm control, i.e. permanent AF;
1+12+60 months
Risk profiles associated with early versus late AF recurrence;
1+12+60 months
Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF
1+12+60 months
Changes in atrial and ventricular echocardiographic parameters
1+12+60 month
- +5 more secondary outcomes
Eligibility Criteria
Patients with short-lasting symptomatic paroxysmal or persistent AF
You may qualify if:
- Short-lasting symptomatic paroxysmal or persistent AF;
- Rhythm control strategy is preferred;
- No contra-indication for oral anticoagulation;
- Age \> 18 years;
- Written informed consent
You may not qualify if:
- Total history of heart failure and/ or of severe valvular disease \> 3 years;
- Severe valvular disease;
- Acute coronary syndrome/ myocardial infarction/ percutaneous coronary intervention/ coronary artery bypass surgery within the past one month;
- Post-operative AF.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical center Groningen
Groningen, Provincie Groningen, 9700 RB, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle C van Gelder, Md PhD
University Medical Center Groningen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 1, 2012
First Posted
January 16, 2012
Study Start
September 1, 2011
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
July 28, 2015
Record last verified: 2015-07