NCT02997670: QUARTRMASTER

Quartet Lead With Defibrillator Multisite Algorithmic Cardiac Resynchronisation Therapy Optimisation

Withdrawn NA Last updated 22 January 2020

What this trial tests

NA trial testing Algorithmic Cardiac Resynchronisation Therapy Optimisation in Heart Failure, Systolic. Withdrawn.

Timeline

1 July 2019

Primary endpoint
1 July 2019

1 July 2019

Quick facts

Lead sponsor	Cardiff and Vale University Health Board
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 July 2019
Primary completion	1 July 2019
Estimated completion	1 July 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Algorithmic Cardiac Resynchronisation Therapy Optimisation

Conditions studied

• Heart Failure, Systolic — all drugs for Heart Failure, Systolic →

Sponsor

Cardiff and Vale University Health Board

Who can join

18 and older, any sex, with Heart Failure, Systolic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiac resynchronisation therapy (CRT) improves outcomes and symptoms in selected patients with heart failure. However, around one third of suitable patients do not demonstrate benefit following device implantation when assessed by echocardiography (heart scanning). This group has poorer outcomes.

Response rate can be enhanced by altering timing delays between the pacing leads, but some patients still fail to improve.

Quadripolar left ventricular leads are now widely used in CRT. The lead's four poles increase the number of conformations available to the programmer, allowing multiple vectors to be programmed simultaneously or sequentially. This allows programming to avoid, for example, a patch of scar and find an area that will respond better to pacing. This technique is known as multi-site pacing. CRT is often implanted along with a defibrillator lead in the right ventricle, known as CRT-D. The defibrillator lead offers further combinations for pacing.

Goal of Research To evaluate an algorithm for assessing different multi-site pacing combinations in optimisation of CRT

Outline The investigators will recruit 24 consecutive patients undergoing CRT-D implantation for conventional indications at our hospital. At baseline, patients will undergo echocardiography, exercise testing and assessments of functional ability and quality of life. The device will be implanted as standard. Optimisation will be performed with an algorithm using different vector combinations and assessing the heart's efficiency through echocardiography and invasive pressure monitoring. The pacemaker will be programmed with standard settings. After twelve weeks, the baseline investigations and optimisation algorithm will be repeated and the device programmed according to the maximum efficiency. After a further 12 weeks, the same parameters will be measured to look for improved response to CRT.

Potential Benefit To increase the response rate to cardiac resynchronisation therapy and improve reliability of the technique

Publications & conference data

No peer-reviewed publications indexed yet for this trial.