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Completed

NCT Number: NCT00941850

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Leicester HNS trust

Leicester, England, LE3 9QP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upgrade to triple ventricular site CRT

Procedure

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).

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. NYHA class

    Time frame: 3 and 6 months

  2. ECHO parameters (LVEDV/ESV, LVEF, MR severity, dyssynchrony indices: time to peak velocity/strain/deformation/time to minimal volume)

    Time frame: 3 and 6 months

  3. MVO2 max

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Registry information

Official study title

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

Acronym: TRIVENT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2009
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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