Can new computer software technology be used to help place the pacing lead on the left side of the heart in the most beneficial position when a participant has a cardiac resynchronisation therapy device (CRT-D) implant?

Not Applicable

Suspended

• Conditions: Ischaemic cardiomyopathy; Circulatory System

• Registration Number: ISRCTN91522248
• Lead Sponsor: Guy's and St Thomas's NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-02
• Last Update Posted: 1 June 2020
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

1. >= 18 years of age
2. Standard indication for CRT-P or CRT-D according to ESC/EHRA guidelines
3. Stable on optimal medical therapy for at least 3 months
4. Ischaemic aetiology
5. Patients with atrial fibrillation can be included

Exclusion Criteria

1. Any contraindication to pacing/implantable cardioverter-defibrillator (ICD) implant
2. Requirement for endocardial pacing
3. Contraindication to magnetic resonance (MR) scanning
4. Claustrophobia
5. Significant renal impairment with estimated glomerular filtration rate (eGFR) < 30 ml/minute
6. Existing pacemaker or ICD system or extraction of a CRT system within the last 6 months
7. Be pregnant or plan to become pregnant over the next 7 months
8. Participation in other studies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
End systolic volume (ESV) in (ml) measured using a 2D echocardiogram at baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. End diastolic volume (ESV) in (ml) measured using a 2D echocardiogram at baseline and 6 months<br> 2. Ejection fraction (%) measured using a 2D echocardiogram at baseline and 6 months<br> 3. Quality of life measured using a Minnesota Living with Heart Failure Questionnaire score at baseline and 6 months<br> 4. Efficacy of device implant measured using clinical composite score at 6 months<br> 5. Class of heart failure measured using NYHA class at baseline and 6 months<br>