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

TRIple-site VENTricular Pacing in Non-responders to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00941850

Acronym

TRIVENT

Enrollment

Registered

2009-07-20

Start date

2009-07-31

Completion date

2012-11-30

Last updated

2015-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac resynchronizton therapy, CRT, Heart failure, Dyssynchrony, Echocardiography, Pacemakers, Nonresponders

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.

Interventions

PROCEDUREUpgrade to triple ventricular site CRT

Patients in this arm will continue to receive CRT via the original unit, but some 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
NYHA class	3 and 6 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026