An evaluation of the benefits of frequent optimisation using QuickOpt in patients with Cardiac Resynchronisation Therapy Defibrillator Device (CRT-D)

Not Applicable

Completed

• Conditions: ife-threatening ventricular arrhythmias; Life-threatening ventricular arrhythmias; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12610000051044
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Patient meets current CRT-D indications and be implanted with a St. Jude Medical (SJM) CRT-D device with V-V timing and a copatible lead system.
- Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath
-Patient has the ability to independantly comprehend and complete a Quality Of Life (QOL) questionnaire
- Patient is geographically stable and willing to coply with the required follow up schedule

Exclusion Criteria

- Patient has an epicardial ventricular lead system
-patient has the ability to walk greater or equal to 450 meters in 6 meters
- Patient has limited intrinsic atrial activity (<40bpm)
- Patient has persistent or permanent Atrial Fibrillation (AF)
- Patient has a 2 or 3 degree heart block
- Patients life expectancy is less than a year
- Patient is less than 18yrs old
- Patient is pregnant
- Patient is on an Intravenous (IV) inotropic agent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart Failure (HF) clinical composite score as defined by Packer: Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure, Journal of Cardiac Failure 2001: 7, 2; 176-182.[Improvement at 12 months over baseline]

Secondary Outcome Measures

Name	Time	Method
All-cause cardiovascular and heart failure mortality: Any cause during the 12month follow up will be collected for all patietns within 2 weeks of the incident - Complete device interrogation, print device data and Adverse Event/hospitalisation Case Report Form (CRF) completion[Up to 12 months post implant];All-cause cardiovascular and heart failure hospitalisations: Any cause during the 12month follow up will be collected for all patietns within 2 weeks of the incident - Complete device interrogation, print device data and AE/hospitalisation CRF completed[Up to 12 months post implant.]