NCT01867060

Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community

Using a Personal Heart Rhythm Monitor (PHRM) to Diagnose Paroxsymal Atrial Fibrillation (PAF) in the Community; and the PREDICT-PAF Substudy - an Investigation of Biomarkers to Detect PAF.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: University of Surrey · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week. A case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF. A further case-control study will assess markers of left atrial function in patients with PAF and their matched controls. Another case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.

Detailed description

Patients with suspected AF will be initially referred to a community-based, nurse-led Arrhythmia clinic by their General Practitioners over a 15-month period. All patients will be issued with a one week ACER (the 'R. Test 4 Evolution'), seen as the 'best-practice' investigation for this population group. Participants will also be issued with a PHRM for three months. They will be instructed to take regular twice-daily, 30 second recordings with additional recordings in the event of relevant symptoms. They will return the ACER after one week and the PHRM after 3 months. A subgroup of participants (target recruitment number = 100) will undergo transthoracic echocardiography. A 40ml venous blood sample will also be taken. Another small subgroup (target recruitment = 20) will be asked to continue twice-daily recordings using the PHRM for a further nine months and will be issued with a repeat one week ACER at study completion.

Conditions

• Paroxysmal Atrial Fibrillation
• Stroke

Interventions

Type	Name	Description
DEVICE	Automated Cardiac Event Recorder	Automated Cardiac Event Recorder to be worn continuously for one week.
DEVICE	Personal Heart Rhythm Monitor	Personal Heart Rhythm Monitor to be used twice-daily for three months.

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-08-01
• Completion: 2016-08-01
• First posted: 2013-06-03
• Last updated: 2017-04-26

Locations

1 site across 1 country: United Kingdom