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Clinical Trials/ACTRN12619000799156
ACTRN12619000799156Not yet recruiting未知

The Role of an Implantable Loop Recorder for symptom control in patients with Paroxysmal Atrial Fibrillation: A Tertiary Level Atrial Fibrillation Clinic with Nurse Led Management.

Melissa Harvey0 sites30 target enrollmentStarted: May 30, 2019Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Not yet recruiting
Sponsor
Enrollment
30

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to 75 Years (—)
Sex
All

Inclusion Criteria

  • Over the age of 18 years and under the age of 75 years.
  • - Documented evidence of Paroxysmal Atrial Fibrillation through any type of ECG or Holter monitoring.
  • - A high burden of Atrial Fibrillation symptoms reported by the patient (at least monthly).
  • - A normal heart structure and normal left ventricular function. Normal LVEF. Normal valves.
  • - Subject able and willing to give informed consent and return for all required study follow-up visits

Exclusion Criteria

  • - Under the age of 18 years and over the age of 75 years.
  • - Documented Persistent AF.
  • - Documented Atrial Flutter.
  • - Documented reversible cause for AF e.g. thyroid disease.
  • - Previous cardiac surgery.
  • - Structural heart disease.
  • - Previous left atrial ablation.
  • - Subject has an active systemic infection.
  • - A history of unstable angina, previous myocardial infarction or percutaneous intervention.
  • - A history of chronic obstructive pulmonary disease or evidence of other significant lung disease.
  • - Contraindication for oral anticoagulation.
  • - Previous TIA or stroke.
  • - Significant congenital heart defect.
  • - Evidence of congestive cardiac failure or left ventricular dysfunction.
  • - Hypertrophic cardiomyopathy.
  • - Abnormal long or short QT interval, signs of Brugada syndrome or Arrhythmogenic right ventricular dysplasia.
  • - History of sarcoidosis.
  • - History of myxoma.
  • - Pregnancy or breastfeeding.
  • - Life expectancy less than 2 years.
  • - Subject is employed by Medtronic or a close relative of investigators.

Investigators

Sponsor
Melissa Harvey

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