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Clinical Trials/NCT03124576
NCT03124576
Unknown
Not Applicable

Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of AF- The Tissue Bank Project

Academisch Ziekenhuis Maastricht1 site in 1 country380 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Academisch Ziekenhuis Maastricht
Enrollment
380
Locations
1
Primary Endpoint
Biochemical factors in atrial biopsies and blood samples
Last Updated
7 years ago

Overview

Brief Summary

In the proposed study the investigators aim to clarify the relative contribution of these different mechanisms to the progression of atrial fibrillation (AF). Also the contribution of the individual genetic background will be investigated. Furthermore, the investigators aim to identify clinical parameters and biomarkers informing on the main mechanisms of AF progression in atrial tissue.

For this purpose, in all included patients atrial biopsies will be taken during cardiac surgery.

Detailed Description

An estimated 380 patients will be included Four patient categories will be included enabling to study patients with different stages of AF progression; 1. Patients without history of atrial fibrillation, without new onset atrial fibrillation detected by continuous rhythm monitoring after surgery (control group), 2. Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring, 3. Patients with self-terminating atrial fibrillation at inclusion, and 4. Patients with non-self-terminating atrial fibrillation at inclusion. At baseline in-depth phenotyping and genotyping will be performed. Continuous rhythm monitoring will also be performed in all patients. The combination of extensive phenotyping, genotyping and atrial fibrillation burden follow-up offers the unique opportunity to study the atrial tissue alterations and atrial gene expression changes in different stages of atrial fibrillation progression and to correlate these data to the phenotype of the patients.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
October 2021
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

J. G. Maessen

Prof. Dr.

Academisch Ziekenhuis Maastricht

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years;
  • Undergoing first elective open chest cardiac surgery or surgical ablation for atrial fibrillation;
  • Able and willing to sign informed consent for the registry;
  • Able and willing to undergo implantation of implantable loop recorder (unless the patients has a pacemaker or implantable cardioverter-defibrillator (ICD) with atrial leads)

Exclusion Criteria

  • • Deemed unsuitable or not willing to undergo implantation of implantable loop recorder or attend follow-up visits.
  • Pregnancy.
  • Life expectancy of less than 2.5 years.
  • History of prior cardiac surgery or ablation for atrial fibrillation.

Outcomes

Primary Outcomes

Biochemical factors in atrial biopsies and blood samples

Time Frame: 2.5 year follow up

Biochemical factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression

Molecular factors in atrial biopsies and blood samples

Time Frame: 2.5 year follow up

Molecular factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression

Genetic factors in atrial biopsies and blood samples

Time Frame: 2.5 year follow up

Genetic factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression

Secondary Outcomes

  • AF complexity(2.5 year follow up)
  • Atrial fibrillation burden(2.5 year follow up)
  • Major adverse cardiovascular and cerebrovascular events(2.5 year follow up)
  • First recurrent atrial fibrillation;(2.5 year follow up)
  • AF progression(2.5 year follow up)
  • Number of atrial fibrillation episodes(2.5 year follow up)
  • Duration of atrial fibrillation episodes(2.5 year follow up)

Study Sites (1)

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