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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 is currently recruiting participants.
Verified August 2012 by University Hospitals, Leicester
Sponsor:
Information provided by (Responsible Party):
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00941850
First received: July 16, 2009
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TRIple-site VENTricular Pacing in Non-responders to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NYHA class [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • MVO2 max [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: July 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941850

Contacts
Contact: GAndre Ng, MB ChB, PhD +441162563297 gan1@le.ac.uk
Contact: Mohamed Jeilan, BM MRCP +441162563643 mhj4@le.ac.uk

Locations
United Kingdom
University of Leicester HNS trust Recruiting
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

No publications provided

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT00941850     History of Changes
Other Study ID Numbers: UHL10707
Study First Received: July 16, 2009
Last Updated: August 15, 2012
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on May 16, 2013