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

NCT00941850 | Completed Phase 4

• 1 other identifier: UHL10707
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

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

  6 months

Secondary Outcomes (3)

• NYHA class

  3 and 6 months

• 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

Study Arms (2)

Triple site CRT

EXPERIMENTAL

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

Optimised medical and device therapy

NO INTERVENTION

These patients will receive optimised medical and device therapy.

Interventions

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).

Triple site CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

University of Leicester HNS trust

Leicester, England, LE3 9QP, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• GAndre Ng, MB ChB, PhD

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 20, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

GB (1)