Detection of Heart Rhythm and BP With RhythmPadBP (SLAF-BP)

A Study to Evaluate the Effectiveness of a Novel Device, the RhythmPadBP, in Accurately Detecting Heart Rhythm and Recording Blood Pressure Simultaneously

This study will assess a new device, the RhythmPadBP, which detects heart rhythm and measure blood pressure simply by placing palms of the hands on a pad containing titanium electrodes.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Device: RhythmPadBP

Detailed Description

Normally the way a doctor will assess the rhythm of the heart involves asking for an electrocardiogram (ECG) which involves having to remove clothing, and sometimes shaving hair. 10 different leads are attached to stickers that are placed on the chest, and other parts of the body. This is known as a 12-lead ECG and is the standard way that heart-rhythm problems are first investigated. The usual method of measuring blood pressure (BP) involves wrapping a cuff around the arm and inflating it to enough to measure the BP. The reading is then displayed on a monitor. This can sometimes be uncomfortable and is often time consuming, particularly in busy clinical settings.

Recent advances in technology however have given us different ways of gaining some of the same information given by a 12 lead ECG and the standard BP apparatus, using much easier to use devices. One of these devices is the RhythmPadBP system by Cardiocity TM. This is a device where participants can record the underlying heart rhythm and BP readings simply by placing palms of both hands on the device. This device does not require removal of clothing or placing a BP cuff around arm and so the readings can be gained more rapidly and with greater convenience.

Investigators propose to test this device to assess how accurately it recognises the most common cardiac rhythm disturbances, e.g. atrial fibrillation (AF), and also measures the blood pressure. This will help to identify AF and any difference of BP in both arms.

AF is an independent risk factor for stroke and increases the risk of stroke by five-fold. A discrepancy of BP in both arms can be a sign of blood vessel disease and is linked to increased risk of cardiovascular and cerebrovascular disease. If investigators find that this device is correctly recording AF and BP, it may give us another simpler way of diagnosing AF and BP discrepancies on both sides.

• Study Type: Observational
• Enrollment (Actual): 1100

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Chertsey, Surrey, United Kingdom, KT16 0PZ
      • Ashford and St Peters NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients attending for routine 12-lead ECG, referred by the primary care physician and also patients attending cardiology department at Ashford & St Peters Hospitals NHS Foundation Trust, Chertsey

Description

Inclusion Criteria:

1. Age greater or equal to 18 years
2. Able to consent
3. No known allergies to the metal or any component used in the RhythmPadBP

Exclusion Criteria:

1. Age less than 18 years
2. Not able to consent
3. Allergies to the metal or any component of the RhythmPadBP device
4. Active skin conditions affecting the hands, i.e. burns, infections
5. In-situ cardiac devices i.e. pacemaker or a defibrillator that could interfere with the ECG recording.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of Atrial Fibrillation	The diagnosis of Atrial Fibrillation will be achieved through Cardiologist review of p-waves and QRS complexes on both a 1 lead and a 12 lead ECG conducted at the time of study for each participant.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of BP in both arms with standard BP apparatus Vs RhythmPad BP recordings	Measurement of blood pressure simultaneously from both arms comparing the two procedures. Both systolic and diastolic blood pressure will be recorded.	18 months

Collaborators and Investigators

• Sponsor: Cardiocity Limited
• Investigators: Principal Investigator: Riyaz A Kaba, MBBS, FRCP, Ashford and St Peter's Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2017
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2016RAK01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided