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

NHS Trust

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Procedure: Upgrade to triple ventricular site CRT

Study type: Interventional

Funder types: Other

Identifiers

NCT00941850

UHL10707

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Triple site CRT

Experimental group

Description:

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

Treatment:

Procedure: Upgrade to triple ventricular site CRT

Optimised medical and device therapy

No Intervention group

Description:

These patients will receive optimised medical and device therapy.