NOACs for Atrial Tachyarrhythmias in Congenital Heart Disease

NCT02928133 | Unknown DMC

• 1 other identifier: 036.19
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Adult patients with congenital heart disease (CHD) with atrial tachyarrhythmias need to be anticoagulated. It is not known whether non-vitamin K antagonist oral anticoagulants (NOAC) in this patient group are efficient and safe. Aim: The purpose of the NOTE registry is to evaluate the efficacy and safety of NOACs for thromboembolic prevention in atrial tachyarrhythmias in adult patients with congenital heart disease (CHD). Methods: In this multicenter prospective registry adult CHD patients with atrial tachyarrhythmias on NOACs (switch from VKA or new on anticoagulants) will be followed for a minimum of two years. Primary efficacy endpoints are defined as thromboembolism, i.e. the composite of ischemic stroke, systemic and pulmonary embolism and intracardiac thrombosis, and as the composite of stroke and systemic embolism. Primary safety endpoint is defined as major bleeding according to the ISTH criteria. Secondary endpoints include each thromboembolic or bleeding event analysed separately, all-cause mortality, therapy adherence, quality of life, risk assessment of stroke and evaluation of natural history of atrial tachyarrhythmia in adult CHD patients. Primary endpoint assessment will be performed with a per protocol analysis, and demonstrated as Kaplan Meyer estimates of event free survival and event rates per year.

Conditions

Congenital Heart Defects; Atrial Fibrillation; Ectopic Atrial Tachycardia

Keywords

Non-vitamin K antagonist oral anticoagulant (NOAC); Congenital heart disease; Atrial fibrillation; Atrial tachyarrhythmia; Thromboembolism

Outcome Measures

Primary Outcomes (4)

• Thromboembolism

  The composite of ischemic stroke, systemic and pulmonary embolism and intracardiac thrombosis

  2 years after enrolment

• Stroke

  2 years after enrolment

• Major bleeding

  The composite of fatal bleeding, symptomatic bleeding in a critical organ (e.g. central nervous system, retroperitoneal, pericardial, intramuscular with compartment syndrome), and bleeding of any kind with the need for \>1 packed cell, or a decrease in hemoglobin of more than 2 g/l / 1,24 mmol/l. \[International Society of Thrombosis and Hemostasis (ISTH) criteria\]

  2 years after enrolment

• Systemic embolism

  2 years after enrolment

Secondary Outcomes (7)

• All-cause mortality

  2 years after enrolment

• Myocardial infarction

  2 years after enrolment

• Cardiac or non-cardiac surgical and percutaneous interventions

  2 years after enrolment

• Minor bleedings

  2 years after enrolment

• General quality of life

  2 years after enrolment

Other Outcomes (7)

• Natural history of atrial tachyarrhythmias in CHD

  2 years after enrolment

• Natural history of atrial tachyarrhythmias in CHD

  2 years after enrolment

• Natural history of atrial tachyarrhythmias in CHD

  2 years after enrolment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Registry population consists of CHD patients with tachyarrhythmia's, defined as atrial fibrillation (AF) or atrial tachycardia's (AT), including atrial flutter, on NOACs. Patients with new-onset atrial tachyarrhythmia's who are eligible for NOACs, will be started directly on a NOAC. Patients on vitamin K antagonists (VKA) can be switched actively to NOACs during outpatient clinic visits, in case of agreement of both patient and physician. The switch can be initiated for various reasons, including bleeding complications on VKA, unstable INR measurements, and user friendliness. Eligibility for NOAC use is defined conform clinical practice, i.e. a patient with nonvalvular atrial tachyarrhythmia's, but without a mechanical heart valve, significantly elevated risk of bleeding, impaired renal function, or pregnancy.

You may qualify if:

• Atrial tachyarrhythmia
• Congenital heart disease
• Treatment with NOAC

You may not qualify if:

• expected survival of less than two years
• additional indication for anticoagulation besides atrial tachyarrhythmia's

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• The Interuniversity Cardiology Institute of the Netherlands: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Atrial Fibrillation; Tachycardia, Ectopic Atrial; Thromboembolism

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia, Supraventricular; Tachycardia; Cardiac Conduction System Disease; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Hayang Yang, MD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

• Barbara Mulder, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

• Berto Bouma, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

Central Study Contacts

Hayang Yang, MD

CONTACT

+31 (0) 20 566 86 87; h.yang@amc.nl

Berto Bouma, MD PhD

CONTACT

+31 (0) 20 566 91 11; b.j.bouma@amc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: October 10, 2016
• Study Start: April 1, 2014
• Primary Completion: May 1, 2018
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

NL (1)