Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation

NCT01917981 | Withdrawn Phase 3 DMC

• 1 other identifier: HASTE-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to determine the sensitivity and specificity of a Personal Heart Rhythm Monitor in the detection of prolonged paroxysmal atrial fibrillation (defined as lasting more than 12 hours) against pre-existing implantable devices, seen to be the 'gold-standard' for arrhythmia detection.

Conditions

Paroxysmal Atrial Fibrillation; Stroke

Keywords

Intermittent cardiac monitoring; Implantable device

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of detection of prolonged paroxysmal atrial fibrillation (PAF) using a Personal Heart Rhythm Monitor (PHRM), compared to an implantable device.

  Measured (%) as the number of identified episodes of prolonged PAF using the PHRM compared to the gold standard implantable device in all patients over the 3 month period.

  18 months

Secondary Outcomes (3)

• The sensitivity and specificity of detection of all episodes of PAF using a PHRM, compared to an implantable device.

  18 months

• Participant compliance with twice-daily recordings with the PHRM for a three month period.

  18 months

• The concordance of the interpretation of PHRM recordings by a Research Nurse and blinded Cardiologist.

  18 months

Study Arms (1)

Personal Heart Rhythm Monitor

EXPERIMENTAL

Intermittent cardiac monitoring with a Personal Heart Rhythm Monitor for three months.

Device: Personal Heart Rhythm Monitor

Interventions

Personal Heart Rhythm Monitor DEVICE

Also known as: Portable ECG monitor HCG-801 - OMRON Healthcare

Personal Heart Rhythm Monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prolonged AF (defined as an episode at least 12 hours duration) in the last month whilst attending routine pacemaker check
• Pacing requirement \< 25% during the last month

You may not qualify if:

• Lack of capacity
• Inability to use the Personal Heart Rhythm Monitor due to cognitive or physical impairment
• Commencement of new anti-arrhythmic drug since last pacemaker check

Sponsors & Collaborators

• University of Surrey: lead
• Royal Surrey County Hospital NHS Foundation Trust: collaborator
• Ashford and St. Peter's Hospitals NHS Trust: collaborator

Study Sites (2)

St Peter's Hospital

Chertsey, Surrey, KT16 0PJ, United Kingdom

Location

Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Related Links

• HASTE charity website

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Philippa J Howlett, MBChB MRCP

  The University of Surrey and The Royal Surrey County Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: August 7, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

GB (2)