None listed
Conditions
Brief summary
The purpose of this study is to prospectively evaluate the benefits of frequent AV/PV and V-V delay optimisation using QuickOpt in patients iwth CRT-D devices
Interventions
The study is aimed at demonstrating that frequent AV/PV and V-V delay optimisation using QuickOpt in patients with Cardiac Resynchronisation Therapy Defibrillation devices results in improved clinical response over standard of care (i.e. empiric programming or one-time optimisation using any non-intracardiac electrogram optimisation methods). SJM has developed inter-ventricular (V-V) delay optimisation to synchronize the electrical activation of the conducted intrinsic and paced wavefronts betw
The study is aimed at demonstrating that frequent AV/PV and V-V delay optimisation using QuickOpt in patients with Cardiac Resynchronisation Therapy Defibrillation devices results in improved clinical response over standard of care (i.e. empiric programming or one-time optimisation using any non-intracardiac electrogram optimisation methods). SJM has developed inter-ventricular (V-V) delay optimisation to synchronize the electrical activation of the conducted intrinsic and paced wavefronts between the pacing electrodes. The Atrio-ventricular (AV/PV) optimisation method characterises the inter-atrial conduction patterns in order to maximise preload and allow for proper timing of mitral valve closure. The intervention is observed for a period of 12 months, from which time the device will remain implanted.
Sponsors
St. Jude Medical
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed