Palpitations research study
What is the primary objective of this study?
Who is eligible to participate?
Inclusion Criteria: - Age 18 years or older - Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness) - Terminates before presentation to hospital - Episodes occur at a frequency of less than once every two weeks - Never previously caught on ECG or ambulatory monitoring - Normal resting ECG Exclusion Criteria: - Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR >1.6, ongoing infection, sepsis or fever, etc. - Palpitations suggestive of extrasystoles (single missed or dropped beats) - Known or suspected severe valvular or myocardial heart disease - An audible heart murmur - Any abnormality on the surface ECG - Thyrotoxicosis - Patients who refuse an ILR when offered will not be included in either limb of the study
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Implantable Loop Recorder
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Group 1: ILR Group
Group 2: ConventionalGroup randomised to conventional lines of investigation
Start Date: April 2010
Primary Outcome: The primary endpoint of the study is the proportion of patients achieving a definite diagnosis in each of the two groups at the end of one year
Study sponsors, principal investigator, and references
Principal Investigator: Richard Schilling, MD, FRCP