Boston Scientific OPTIMIND 2 Medical Device study
Research type
Research Study
Full title
Clinical Outcome of Pacemaker paTIents according to pacing Modality and primary INDications OPTI-MIND 2
IRAS ID
132156
Contact name
Nicholas Linker
Contact email
Sponsor organisation
Guidant Europe (A Boston Scientific Company)
Clinicaltrials.gov Identifier
Research summary
OPTI-MIND 2 is a Prospective, observational, non-randomized, comparative with historical control (OPTI-MIND), post-market study conducted at multiple centres worldwide.
The primary purpose of the study is to demonstrate and collect standard information about the pacemaker and the subjects implanted with any Boston Scientific pacemaker device equipped with RYTHMIQTM feature compared to data from subjects implanted with ALTRUATM PM (without RYTHMIQ). The RYTHMIQTM feature ensures that the lower heart chambers contract (beat), should the subjects heart fail to send a signal in time from upper to lower chamber
The new BSC PMs (Pace-Makers) equipped with RYTHMIQTM algorithm are expected to minimize unnecessary ventricular pacing in subjects with preserved AV conduction and 1st and 2nd degree AV (Atrioventricular) block. This reduction could potentially minimize the unwanted clinical events due to unnecessary pacing. The study is designed to investigate the effect of minimizing ventricular pacing on clinical outcomes in specific bradycardia population without permanent or intermittent AV block
All subjects implanted with any of BSC PM devices equipped with RYTHMIQ who fulfil the selection criteria and are enrolled in the study will be automatically assigned to the Study group. Control group is formed by data from subjects already enrolled in OPTI-MIND study.
Each subject will be followed for a period of two years after enrolment according to the schedule and standard practice at the enrolling centres. There will be no additional visits for subjects who participate in the study.Test Device - All devices and algorithms included in this study are approved for general market release in the countries where study will be carried out (or will be market released prior to their use in the study) and will be used under the approved indication.
Approximately 500 subjects will be enrolled in the current study. Up to 70 sites worldwide.
Enrolment is expected to be completed in 16 months; therefore the total study duration is estimated to be 43 months.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
13/NE/0260
Date of REC Opinion
6 Nov 2013
REC opinion
Further Information Favourable Opinion