Long term cardiac monitoring in mitral valve prolapse

Mitral valve prolapse and ventricular arrhythmias: outcomes of continuous cardiac rhythm monitoring

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001159145

Enrollment

Registered

2019-08-19

Start date

2017-05-15

Completion date

2019-08-26

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

MVP is a common clinical diagnosis. Whilst the majority of patients with MVP have a benign prognosis, increased rates of arrhythmias and sudden cardiac death have been reported in some patients with MVP. This observational study will attempt to assess whether patients with MVP are at higher risk of ventricular arrhythmias or sudden death compared to a control cohort. Patients (study group and control group 1) will be recruited after initial echocardiography has identified the presence of mitral valve prolapse and will undergo continuous cardiac rhythm monitoring with an implantable loop recorder. They be followed up for a minimum of 3 months. The patients for control group will be patients who have an ILR inserted for clinical reasons. The primary outcome will be identification of ILR detected ventricular arrhythmias.

Interventions

Patients with mitral valve prolapse will be recruited for insertion of a continuous cardiac rhythm monitor (implantable loop recorder - ILR). Outcomes over a 2 year period will be compared to patients with ILR for other reasons. An ILR is a USB sized device designed to provide continuous heart rhythm monitoring. insertion of an ILR is performed under local anaesthesia. A 2cm incision is made at the 4th intercostal space at the left sternal edge. The device is inserted into the subcutaneous tissue through this incision. The ILR will be inserted by a cardiologist (Dr. Hui-Chen Han and Dr. Han S. Lim will be responsible for ILR insertion in the study participants). After ILR insertion, patients will be reviewed at 3 monthly intervals over a 2 year period

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Mitral valve prolapse diagnosed by echocardiography.

Exclusion criteria

Nil

Outcome results