NCT03811691

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 18, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

2.4 years

First QC Date

January 15, 2019

Last Update Submit

June 7, 2021

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 month post MRI

Secondary Outcomes (4)

  • Ventricular Pacing Capture Threshold (PCT) stability in the right atrium and ventricle following the MRI scan

    1 month post MRI

  • Atrial Pacing Capture Threshold stability in the right atrium and ventricle following the MRI scan

    1 month post MRI

  • Ventricular sensed amplitude stability in the right atrium and ventricle following the MRI scan

    1 month post MRI

  • Atrial sensed amplitude stability in the right atrium and ventricle following the MRI scan

    1 month post MRI

Study Arms (2)

1.5 Tesla MRI Scan

OTHER

Subjects will undergo 1.5T MRI exam

Diagnostic Test: MRI exam

3 Tesla MRI Scan

OTHER

Subjects will undergo 3T MRI exam

Diagnostic Test: MRI exam

Interventions

MRI examDIAGNOSTIC_TEST

Pacing system safety and stability under MRI scan environment

1.5 Tesla MRI Scan3 Tesla MRI Scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MicroPort CRM

Clamart, Haut de Seine, 92140, France

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Anne RousseauPlasse

CONTACT

01 46 01 30 82Anne.RousseauPlasse@crm.microport.com

Hanan Fawaz

CONTACT

01 46 01 89 01hanan.fawaz@crm.microport.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study is an interventional, prospective, multicenter, open label, two arms parallel non-comparative non-randomized study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 22, 2019

Study Start

July 18, 2019

Primary Completion

December 1, 2021

Study Completion

August 1, 2023

Last Updated

June 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)