SMART Registry_Boston Scientific_(0393-0026)
Research type
Research Study
Full title
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry_SMART Registry
IRAS ID
220486
Contact name
Roy S Gardner
Contact email
Sponsor organisation
Guidant Europe, a Boston Scientific Company
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 2 months, 31 days
Research summary
Research Summary
This is a global, multicenter, prospective, observational, single-arm post market study (Registry). Approximately 2000 patients will be enrolled in the study over a maximum of 200 sites in Europe, United States, Canada and Asia-Pacific region.
The aim of the SMART registry is to learn in a general Cardiac Resynchronisation Therapy Defibrillators (CRT-D) population, which optimisation techniques are used and how effective they are. It will compare 12-month response rates among different optimisation methods and characterise which selected patient subgroups achieve better response than others.
A subset of SMART Registry patients will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.
The quadripolar Boston Scientific Corporation (BSC) CRT-D models in the NG3 family (AUTOGEN, INOGEN and DYNAGEN families) used in the study are approved for commercial use. Quadripolar BSC CRT-D models in the NG4 family (RESONATE MOMENTUM, CHARISMA and VIGILANT) will be used in the study once approval by the local regulatory body has been obtained. For CE mark accepting countries CE mark for the NG4 family was issued on 11 January 2017.
All implanted devices will be used within the current labelled indications for use. CRT-D devices are intended to provide cardiac resynchronisation therapy and provide anti-tachycardia pacing and defibrillation therapy.
The study duration is estimated to be approximately 6 years from first enrollment to study closure. Patients enrolled in the SMART Registry will be followed for 12 months. NG4 PMCF patients will be enrolling exclusively from European participating sites and will be followed for a minimum of 36 months.
The data collection will continue until last patient who is participating in the long-term follow-up group has completed the 36 month visit.Summary of Results
A total of 58.8% of patients improved and an additional 20.1% of patients were stabilized (unchanged) after 12 months. A high proportion of patients with Atrial fibrillation, ischemic cardiomyopathy, non-LBBB conduction, and diabetes at baseline were enrolled; these comorbidities had increased the odds of nonresponse. The NG4 PMCF cohort was completed per the CIP and the study endpoint was passed.
The SMART Registry did not have formal hypothesis testing and is exploratory in nature. However, the NG4 PMCF cohort had a safety hypothesis based on the pulse generator-related complication free rate. The Pulse Generator (PG) related complication free rate at 36 months for the NG4 PMCF cohort was 97.9% (2/99). This metric is above the protocol performance goal of 88.5% and therefore satisfies the study endpoint.
There are no new risks discovered in the conduct of this registry that have not been previously reported nor is there an increase in the magnitude of known risk. The clinical benefits and adverse events reported here for CRT-D are consistent with that previously reported in the medical literature for similar CRT-D products in similar heart failure patient populations.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0200
Date of REC Opinion
14 Aug 2017
REC opinion
Further Information Favourable Opinion