This trial is active, not recruiting.

Condition atrial fibrillation
Sponsor I.C. Van Gelder
Collaborator Netherlands Heart Foundation
Start date April 2011
End date March 2017
Trial size 500 participants
Trial identifier NCT01510210, NHS2010B233


The objective of this study is to assess the risk profile in patients with atrial fibrillation, which represents the degree of changes in the atrial tissue and which can help predict in which patients rhythm control will be successful. This risk profile will consist of a combination of underlying (heart) disease and risk factors, measurements obtained from echocardiograms, and circulating biomarkers. Ultimately this risk profile can be used to guide type of rhythm control therapy in individual patients with atrial fibrillation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Success of rhythm control
time frame: 12 month

Secondary Outcomes

Time to recurrence of (a)symptomatic AF
time frame: 1+3+6+9+12 month
Failure of rhythm control, i.e. permanent AF
time frame: 1+3+6+9+12 month
Risk profiles associated with early versus late AF recurrence
time frame: 1month and 12 month
Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF
time frame: 1+3+6+9+12 month
Changes in atrial and ventricular echocardiographic parameters
time frame: 1month and 12 month
Cardiovascular morbidity and mortality
time frame: 1month and 12month
Pulmonary vein ablation
time frame: 1month, 3month, 6month, 9 month, 12month
Pathophysiological mechanisms associated with AF and success of rhythm control
time frame: baseline-12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Short-lasting symptomatic paroxysmal or persistent AF; - Rhythm control strategy is preferred; - No contra-indication for oral anticoagulation; - Age > 18 years; - Written informed consent Exclusion Criteria: - 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.

Additional Information

Official title Identification of a Risk Profile to Guide Atrial Fibrillation Therapy
Principal investigator Harry Crijns, MD PhD
Description Atrial fibrillation is responsible for substantial morbidity and mortality.Identification of patients with atrial fibrillation that is difficult to treat may improve the outcome of rhythm control therapy. Left atrial size could be a useful tool to select patients that will benefit from rhythm control therapy.Beside echocardiographic parameters,atrial fibrillation has been also associated with circulating biomarkers in blood like collagen metabolism, inflammatory mediators,neurohumoral factors and proteins/proteomic profiles. Beside more accepted risk factors (myocardial ischemia, diabetes and pulmonary disease)other less well-known clinical factors (sleep apnea, alcohol or other intoxication abuse, excessive physical activity, esophageal problems and increased body mass index) may also predict the outcome of rhythm control.It likes also plausible that recurrent atrial fibrillation within one month after start of rhythm control are associated with a different risk profile than late atrial fibrillation recurrence.During this study we will try to identify patients with atrial fibrillation who are more or less likely to respond to rhythm control therapy.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Medical Center Groningen.