Status:
UNKNOWN
Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment
Lead Sponsor:
MicroPort CRM
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The interest of the CAPRI study is to confirm the safety and the efficacy of the ENO/TEO/OTO pacing system when used under 1.5 or 3 Tesla MRI environment and in accordance with the MRI solutions guide...
Detailed Description
The purpose of CAPRI study is to confirm the safety and the efficacy of the CE marked MR conditional pacing system composed of the ENO, TEO or OTO pacemaker with VEGA pacing lead(s). Conditions to und...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects who meet all the following criteria at the time of inclusion visit may be included:
- Already implanted in the left or right pectoral region for at least 6 weeks with:
- ENO, TEO or OTO single chamber rate response (SR) pacemaker with a VEGA pacing lead, or
- ENO, TEO or OTO dual chamber rate response (DR) pacemaker with two VEGA pacing leads.
- Implanted pacing system must fulfill the following parameters:
- Battery impedance is \< 5 Kilo Ohm (kΩ)
- Pacing capture threshold value is ≤ 2 Volts (V) at 0.35 millisecond (ms)
- Lead impedance value between 200Ω and 3000Ω
- No diaphragmatic or pectoral stimulation at 5V/1ms
- P-wave minimum sensed amplitude ≥ 1mV for patients with sinus rhythm
- R-wave minimum sensed amplitude ≥ 4mV for patients with spontaneous conduction rhythm
- Must agree to undergo a non clinically-indicated MRI scan without intravenous injection and without sedation;
- Have reviewed, signed and dated informed consent.
- Subjects who meet any of the following criteria are not eligible to be included in the study:
- Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device;
- Have other active or abandoned cardiac implants already implanted;
- Have other active or passive non MR conditional devices implanted such as metallic foreign body;
- Have a history of brain aneurysm with ferromagnetic clipping;
- Have a planned cardiac surgery within the 3 months of inclusion;
- Have a medical MRI examination prescription planned within the 3 months of inclusion;
- Age less than 18 years old or under guardianship or kept in detention;
- Known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method ;
- Be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate.
Exclusion
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT03811691
Start Date
July 18 2019
End Date
August 1 2023
Last Update
June 9 2021
Active Locations (1)
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1
MicroPort CRM
Clamart, Haut de Seine, France, 92140