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

Stroke Clinical Trial

Official title:

Testing the Accuracy of an Intermittent Personal Heart Rhythm Monitor (PHRM) to Detect Prolonged Paroxysmal Atrial Fibrillation (PAF) Against Implantable Devices.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01917981
• Other study ID #: HASTE-1
• Status: Withdrawn
• Phase: Phase 3
• First received: July 12, 2013
• Last updated: April 24, 2017
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: April 2017
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The Investigators aim to recruit 30 volunteers with implantable devices (either conventional pacemakers, with an atrial lead or implantable loop recorders, devices inserted under the skin to monitor the heart rhythm). They will be attending for their routine pacemaker checks in a number of clinics in Surrey.

Potential participants will have documented prolonged paroxysmal atrial fibrillation (PAF, an intermittent irregular heart rhythm which is known to predispose to stroke), lasting at least 12 hours, identified in the last month prior to the pacemaker check.

Willing patients will then be issued with a PHRM (Personal Heart Rhythm Monitor) device to make heart rhythm recordings for 3 months. They will do this twice-daily for 30 seconds for this period. At the end of the 3 month period patients will undergo a final pacing device check. Identification of prolonged PAF using the PHRM device will be compared to the implantable device.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Stroke

Intervention

Device:
• Personal Heart Rhythm Monitor

Locations

Country	Name	City	State
United Kingdom	St Peter's Hospital	Chertsey	Surrey
United Kingdom	Royal Surrey County Hospital NHS Foundation Trust	Guildford	Surrey

Sponsors (3)

Lead Sponsor	Collaborator
University of Surrey	Ashford and St. Peter's Hospitals NHS Trust, Royal Surrey County Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The sensitivity and specificity of detection of all episodes of PAF using a PHRM, compared to an implantable device.	Measured (%) as the number of identified episodes of all episodes of PAF (lasting at least 30 seconds) using the PHRM compared to the gold standard implantable device in all patients over the 3 month period.	18 months
Secondary	Participant compliance with twice-daily recordings with the PHRM for a three month period.	Measured as actual number of recordings made out of 180 requested recordings and expressed as a percentage.	18 months
Secondary	The concordance of the interpretation of PHRM recordings by a Research Nurse and blinded Cardiologist.	The agreement in the diagnosis of normal sinus rhythm and PAF using PHRM recordings between a Research Nurse and Cardiologist expressed as a percentage.	18 months

External Links

•   HASTE Academy website
•   HASTE charity website