A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Procedure: Upgrade to triple ventricular site CRT

• Registration Number: NCT00941850
• Lead Sponsor: University Hospitals, Leicester

Brief Summary

Patients are randomised to receive ongoing optimised device and medical therapy or triple ventricular site resynchronisation. The hypothesis states that patients receiving triple-site resynchronization will exhibit a better response.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-17
• Study First Posted: 2009-07-20
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Implanted with a CRT device > 6 months previously according to current and conventional CRT indications
• Device optimization > 1 months previously
• Aged 18yrs or older
• Able to attend outpatient follow up

Exclusion Criteria

• Recent MI (<2 months)
• Women who are pregnant or planning pregnancy
• Severe co morbid illness (where patients are not expected to survive duration of follow up period or where repeated outpatient visits may not be in best interest of patients)
• Upgrade procedure is contraindicated for safety reasons.
• Class IV inotropic agents
• Patient unwilling to comply with required follow-up protocol including randomization scheme

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triple site CRT	Upgrade to triple ventricular site CRT	These patients will continue to receive CRT via existing device but will have a change in the mode of delivery of therapy (by placing a second pacing lead to reach a different part of the left ventricle from the part originally paced

Primary Outcome Measures

Name	Time	Method
Proportion of responders in each group. o Clinical response will be defined according to the Packer score o Echocardiographic response will be defined as a 10% relative reduction in left ventricular end systolic volume at six months	6 months

Secondary Outcome Measures

Name	Time	Method
NYHA class	3 and 6 months
ECHO parameters (LVEDV/ESV, LVEF, MR severity, dyssynchrony indices: time to peak velocity/strain/deformation/time to minimal volume)	3 and 6 months
MVO2 max	6 months

Trial Locations

Locations (1)

University of Leicester HNS trust; 🇬🇧 Leicester, England, United Kingdom