Pre box change LV function screening

• Research type

  Research Study

• Full title

  Evaluation of Screening Tools to Assess suitability for Resynchronisation Therapy Patients undergoing Pacemaker generator replaceMent (ESTARTPPM): Studies to evaluate the role of several screening tests for left ventricular dysfunction in patients scheduled for pacemaker generator box change to evaluate if upgrade to cardiac resynchronisation therapy may be appropriate.

• IRAS ID

  188288

• Contact name

  Andrew Flett

• Contact email

  andrew.flett@uhs.nhs.uk

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• Duration of Study in the UK

  0 years, 3 months, 28 days

• Research summary

  Conventional permanent pacemakers are implanted into patients who have problems with their underlying heart rhythm being too slow. Long term pacing of the right ventricular by a permanent pacemaker can lead to decreased cardiac function and patients may develop the symptoms of heart failure. In these cases the patient may benefit from implantation of a cardiac resynchronisation therapy (CRT) device to improve cardiac function.

  Pacemaker generators have a limited battery life and patients need to have these changed every 5-10 years to ensure their pacemaker continues to function. When patients are scheduled for a generator box change, this is an opportune moment to assess their cardiac function to see is they may be a candidate for implantation of a CRT device at the time of their generator box change.

  The current gold standard for assessing patients left ventricular function is an echocardiogram. This investigation can be time consuming and relative expensive as a screening investigation.

  Our study aims to investigate whether a number of simpler screening tests may be helpful in identifying patients who would benefit from upgrade to CRT when they are scheduled for a pacemaker generator box change. These tests will include;

  - An ECG
  - A six minute walk test
  - A NT-ProBNP blood test
  - A short questionnaire

  The patients would also undergo a focused echocardiogram as part of the study.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  15/ES/0181

• Date of REC Opinion

  4 Dec 2015

• REC opinion

  Further Information Favourable Opinion