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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00941850
First Posted: July 20, 2009
Last Update Posted: December 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospitals, Leicester
  Purpose
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.

Condition Intervention Phase
Heart Failure Procedure: Upgrade to triple ventricular site CRT Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TRIple-site VENTricular Pacing in Non-responders to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy

Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • NYHA class [ Time Frame: 3 and 6 months ]
  • 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 ]
  • MVO2 max [ Time Frame: 6 months ]

Enrollment: 20
Study Start Date: July 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triple 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
Procedure: Upgrade 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).
No Intervention: Optimised medical and device therapy
These patients will receive optimised medical and device therapy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941850


Locations
United Kingdom
University of Leicester HNS trust
Leicester, England, United Kingdom, LE3 9QP
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
Principal Investigator: GAndre Ng, MB ChB, PhD University of Leicester
  More Information

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT00941850     History of Changes
Other Study ID Numbers: UHL10707
First Submitted: July 16, 2009
First Posted: July 20, 2009
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by University Hospitals, Leicester:
Cardiac resynchronizton therapy
CRT
Heart failure
Dyssynchrony
Echocardiography
Pacemakers
Nonresponders

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases