SMART CRT_C2067_Boston Scientific_Heart Failure
Research type
Research Study
Full title
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy. SMART CRT
IRAS ID
229496
Contact name
Paul Roberts
Contact email
Sponsor organisation
Guidant Europe, a Boston Scientific Company
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 11 days
Research summary
SMART CRT is a prospective, double-blind, multicenter, international, randomised controlled trial.
The Cardiac resynchronisation therapy defibrillator (CRT-D) device is specifically designed for patients with a medical condition called heart failure.
The device system consists of a CRT-D in combination with three leads placed in the right ventricle, right atrium and on the outer wall of the left ventricle via venous access. The CRT-D contains the power source and the electronic components. A lead is a thin insulated wire that carries electrical signals to and from the CRT-D and the heart. When the heart is beating too fast or too slow, the device can respond as needed.
The study will be conducted at up to 100 sites globally. An estimated 726 patients will be enrolled in the study in order to achieve a target of at least 370 patients to complete the Six Month Follow-Up. The study progress will be monitored, and if necessary, the number of patients enrolled may be increased to ensure that an adequate number of patients complete the Six Month Follow-Up.
For those patients identified with an RV-LV (Right Ventricle-Left Ventricle) delay ≥70ms, 1:1 randomisation will occur via the electronic data capture (EDC) system. Patients will be randomised to have programmed either an (Atrioventricular) AV Delay and pacing chamber determined by SmartDelay or a Fixed AV Delay of 120ms with BiV pacing.
The primary objective is to show the benefit of SmartDelay in patients with a prolonged RV-LV interval. The primary endpoint is comparing cardiac resynchronisation therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. CRT response is defined by a decrease in Left Ventricular End Systolic Volume (LVESV) ≥ 15% at 6 months compared to pre-implant baseline.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0371
Date of REC Opinion
21 Nov 2017
REC opinion
Further Information Favourable Opinion