Clinical trial NCT03811691: Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment
Official title: Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bradycardia
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2019-01-22
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an interventional, prospective, multicenter, open label, two arms parallel non-comparative non-randomized study.
Primary purpose: OTHER

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 guideline.

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 undergo an MRI scan are provided in the MRI solutions guideline.

The primary objective is to confirm the clinical safety of the ENO/TEO/OTO pacing system when used under 1.5 and 3 Tesla specific MRI conditions without scan exclusion zone.

The study secondary main objectives are aiming to assess the performance of the MR conditional pacing system in the right atrium and ventricle at 1 month following the MRI scan:

* Stability of the Pacing Capture Threshold
* Stability of the lead sensed amplitude

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from MRI-related complications following the MRI scan of the ENO/TEO/OTO pacing system
timeFrame: 1 month post MRI
Secondary outcomes:
measure: Ventricular Pacing Capture Threshold (PCT) stability in the right atrium and ventricle following the MRI scan
timeFrame: 1 month post MRI
measure: Atrial Pacing Capture Threshold stability in the right atrium and ventricle following the MRI scan
timeFrame: 1 month post MRI
measure: Ventricular sensed amplitude stability in the right atrium and ventricle following the MRI scan
timeFrame: 1 month post MRI
measure: Atrial sensed amplitude stability in the right atrium and ventricle following the MRI scan
timeFrame: 1 month post MRI
Other outcomes:
Locations:
city: Clamart
country: France
facility: MicroPort CRM
state: Haut De Seine
Study officials:
References: