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Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment (CAPRI)

Primary Purpose

Bradycardia

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
MRI exam
Sponsored by
MicroPort CRM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bradycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • MicroPort CRMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1.5 Tesla MRI Scan

3 Tesla MRI Scan

Arm Description

Subjects will undergo 1.5T MRI exam

Subjects will undergo 3T MRI exam

Outcomes

Primary Outcome Measures

Freedom from MRI-related complications following the MRI scan of the ENO/TEO/OTO pacing system
An MRI-related complication is defined as a Serious Adverse Event (SAE) that led to death or to an invasive intervention or a Device Deficiency that causes the termination of any significant device function per Clinical Event Committee (CEC) adjudication. The primary endpoint will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).

Secondary Outcome Measures

Ventricular Pacing Capture Threshold (PCT) stability in the right atrium and ventricle following the MRI scan
Subject's ventricular pacing capture threshold will be measured in Volt (V) at 0.5ms at baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as a PCT increase less than or equal to 0.5V at 0.5ms between the two visits. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Atrial Pacing Capture Threshold stability in the right atrium and ventricle following the MRI scan
Subject's atrial pacing capture threshold will be measured in Volt (V) at 0.5ms at Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as a PCT increase less than or equal to 0.5V at 0.5ms between the two visits. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Ventricular sensed amplitude stability in the right atrium and ventricle following the MRI scan
Subject's ventricular minimum sensed amplitude will be measured in mV at Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as 50% or less decrease between the two visits. If subject's ventricular minimum sensed amplitude is less or equal to 4mV at time of baseline, then this subject will not count for this endpoint. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Atrial sensed amplitude stability in the right atrium and ventricle following the MRI scan
Subject's atrial minimum sensed amplitude will be measured in mV at baseline. A success is defined as 50% or less decrease between the two visits. If subject's atrial minimum sensed amplitude is less or equal to 1mV at time of Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit, then this subject will not count for this endpoint.The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).

Full Information

First Posted
January 15, 2019
Last Updated
June 7, 2021
Sponsor
MicroPort CRM
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1. Study Identification

Unique Protocol Identification Number
NCT03811691
Brief Title
Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment
Acronym
CAPRI
Official Title
Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort CRM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This study is an interventional, prospective, multicenter, open label, two arms parallel non-comparative non-randomized study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1.5 Tesla MRI Scan
Arm Type
Other
Arm Description
Subjects will undergo 1.5T MRI exam
Arm Title
3 Tesla MRI Scan
Arm Type
Other
Arm Description
Subjects will undergo 3T MRI exam
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI exam
Intervention Description
Pacing system safety and stability under MRI scan environment
Primary Outcome Measure Information:
Title
Freedom from MRI-related complications following the MRI scan of the ENO/TEO/OTO pacing system
Description
An MRI-related complication is defined as a Serious Adverse Event (SAE) that led to death or to an invasive intervention or a Device Deficiency that causes the termination of any significant device function per Clinical Event Committee (CEC) adjudication. The primary endpoint will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Time Frame
1 month post MRI
Secondary Outcome Measure Information:
Title
Ventricular Pacing Capture Threshold (PCT) stability in the right atrium and ventricle following the MRI scan
Description
Subject's ventricular pacing capture threshold will be measured in Volt (V) at 0.5ms at baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as a PCT increase less than or equal to 0.5V at 0.5ms between the two visits. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Time Frame
1 month post MRI
Title
Atrial Pacing Capture Threshold stability in the right atrium and ventricle following the MRI scan
Description
Subject's atrial pacing capture threshold will be measured in Volt (V) at 0.5ms at Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as a PCT increase less than or equal to 0.5V at 0.5ms between the two visits. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Time Frame
1 month post MRI
Title
Ventricular sensed amplitude stability in the right atrium and ventricle following the MRI scan
Description
Subject's ventricular minimum sensed amplitude will be measured in mV at Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit. A success is defined as 50% or less decrease between the two visits. If subject's ventricular minimum sensed amplitude is less or equal to 4mV at time of baseline, then this subject will not count for this endpoint. The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Time Frame
1 month post MRI
Title
Atrial sensed amplitude stability in the right atrium and ventricle following the MRI scan
Description
Subject's atrial minimum sensed amplitude will be measured in mV at baseline. A success is defined as 50% or less decrease between the two visits. If subject's atrial minimum sensed amplitude is less or equal to 1mV at time of Baseline (at the MRI visit - just before the MRI scan) and at 1 month Post-MRI visit, then this subject will not count for this endpoint.The secondary endpoints will be assessed independently for each arm of the study (1.5 and 3 Tesla MRI scan).
Time Frame
1 month post MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne RousseauPlasse
Phone
01 46 01 30 82
Ext
+33
Email
Anne.RousseauPlasse@crm.microport.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hanan Fawaz
Phone
01 46 01 89 01
Ext
+33
Email
hanan.fawaz@crm.microport.com
Facility Information:
Facility Name
MicroPort CRM
City
Clamart
State/Province
Haut De Seine
ZIP/Postal Code
92140
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne RousseauPlasse
Phone
01 46 01 30 82
Ext
+33
Email
Anne.RousseauPlasse@crm.microport.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment

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