Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— RACE V  

Official title:

Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation - An Observational Exploratory Study on Pathophysiological Mechanisms of AF Progression and on the Role of LinQ/CareLink Guided Patient Tailored Therapy in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02726698
• Other study ID #: NL53561.042.16
• Status: Active, not recruiting
• Start date: July 2016
• Est. completion date: October 2024

Study information

• Verified date: May 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to study clinical factors and (blood) biomarkers related to progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with special reference to hypercoagulability. All patients will be continuously monitored for their atrial rhythm to assess AF progression, either through an implantable loop recorder (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both in combination with the CareLink home monitoring system. Remote monitoring and interrogation will be installed and used on a daily basis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• New onset or history of paroxysmal, self-terminating AF documented as:

• AF on ECG or Holter-recording or loop recorder

• Subclinical AF detected in implantable cardiac devices (atrial read > 190 beats per minute, lasting > 6 minutes).

• Prior history of self-terminating AF is allowed;

• Able and willing to sign informed consent for the registry;

• Able and willing to undergo implantation of an implantable loop recorder (in patients without a CIED);

• In patients already on oral anticoagulation drugs, the following inclusion criteria need to be met (to allow for safe temporary interruption of anti-thrombotic treatment for coagulation phenotyping):

• CHA2DS2-VASc score =5 (history of Congestive heart failure, Hypertension, Age = 75 years (doubled), Diabetes mellitus,Stroke/transient ischemic attack (doubled), Vascular disease, Age 65-75 years, female Sex);

• No other indication for oral anticoagulation (e.g. mechanical valve prosthesis);

• Patient is willing to temporarily stop oral anticoagulation drugs (OAC).

Exclusion Criteria:

• Non-self-terminating, persistent AF;

• Deemed unsuitable or not willing to undergo implantation of loop recorder (in patients without a CIED);

• Refusing to temporarily stop OAC for coagulation phenotyping (in patients already on OAC before inclusion in this study);

• On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year;

• Expected to start with amiodarone;

• Pregnancy;

• Life expectancy of less than 2.5 years.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Remodeling
• Thrombophilia

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center - AMC	Amsterdam
Netherlands	Amsterdam University Medical Center - VU	Amsterdam
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Martini Hospital	Groningen
Netherlands	Ommelander Ziekenhuis	Groningen
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Netherlands	Laurentius Hospital	Roermond
Netherlands	Isala	Zwolle

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of AF burden		2.5 years
Secondary	Major Adverse Cardiac and Cerebrovascular Events		2.5 years
Secondary	Change in therapy due to continuous rhythm monitoring with the LinQ/Carelink system		2.5 years