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
Similar Trials
Not yet recruiting
Not Applicable
Clinical Usefulness of Implantable Loop Recorder MonitoringDiseases of the circulatory systemKCT0003289Korea University Anam Hospital50
Recruiting
Not Applicable
Role of Novel ILR in the Management of PVCsPVC - Premature Ventricular ContractionMyocarditisNCT06060548Kansas City Heart Rhythm Research Foundation50
Completed
Not Applicable
Implantable loop recorder for continuous beat-to-beat monitoring (REVEAL) versus conventional strategy in the analysis of syncope of unknown aetiologySigns and SymptomsSyncope and collapseSyncopeISRCTN29754044Academic Medical Centre (AMC) (Netherlands)85
Recruiting
Not Applicable
EO-NORMAL-AF StudyD006333Heart FailureJPRN-jRCTs052210060ishida Taku30
Recruiting
Not Applicable
Follow Up of patients by use of implantable loop recorders after catheter ablation of atrial flutterI48.9Atrial fibrillation and atrial flutter, unspecifiedDRKS00009786Charité-Universitätsmedizin Berlin100
