Back to resultsA Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy (TRIVENT)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Upgrade to triple ventricular site CRT
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Cardiac resynchronizton therapy, CRT, Heart failure, Dyssynchrony, Echocardiography, Pacemakers, Nonresponders
Eligibility 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
Sites / Locations
- University of Leicester HNS trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Triple site CRT
Optimised medical and device therapy
Arm 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
These patients will receive optimised medical and device therapy.
Outcomes
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
Secondary Outcome Measures
NYHA class
ECHO parameters (LVEDV/ESV, LVEF, MR severity, dyssynchrony indices: time to peak velocity/strain/deformation/time to minimal volume)
MVO2 max
Full Information
NCT ID
NCT00941850
First Posted
July 16, 2009
Last Updated
December 7, 2015
Sponsor
University Hospitals, Leicester
1. Study Identification
Unique Protocol Identification Number
NCT00941850
Brief Title
A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
Acronym
TRIVENT
Official Title
TRIple-site VENTricular Pacing in Non-responders to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals, Leicester
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac resynchronizton therapy, CRT, Heart failure, Dyssynchrony, Echocardiography, Pacemakers, Nonresponders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triple site CRT
Arm Type
Experimental
Arm 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
Arm Title
Optimised medical and device therapy
Arm Type
No Intervention
Arm Description
These patients will receive optimised medical and device therapy.
Intervention Type
Procedure
Intervention Name(s)
Upgrade to triple ventricular site CRT
Intervention Description
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 Outcome Measure Information:
Title
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 Measure Information:
Title
NYHA class
Time Frame
3 and 6 months
Title
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
Title
MVO2 max
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GAndre Ng, MB ChB, PhD
Organizational Affiliation
University of Leicester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leicester HNS trust
City
Leicester
State/Province
England
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
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