Trial Outcomes & Findings for INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI (NCT NCT01890512)

NCT ID: NCT01890512

Last Updated: 2016-02-05

Results Overview

The study is aimed at providing confirmatory data of no impact of MRI on device function and patient conditions. Confirmation of no MRI related patient adverse events and/or adverse device effects during MRI visit are assessed as follows: 1. no episodes of asystole, 2. no occurrence of sustained ventricular arrhythmias in the bore, 3. no loss of capture due to rise in pacing threshold.

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: one month
• Results posted on: 2016-02-05

Participant Flow

INFINITE MRI study started subject enrollment on 17 June 2013.Las subject was enrolled on 2 October 2013 and last subject follow up concluded on 17 January 2014. Study database was closed on 28 February 2014.

Participant milestones

Measure	ImageReady Pacemaker patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	ImageReady Pacemaker patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1

Baseline Characteristics

INGENIO MRI/ FINELINE II Pacing System Data Collection in Patients Undergoing MRI

Baseline characteristics by cohort

Measure	ImageReady Pacemaker n=20 Participants patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
Age, Continuous	71.5 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: one month

The study is aimed at providing confirmatory data of no impact of MRI on device function and patient conditions.

Confirmation of no MRI related patient adverse events and/or adverse device effects during MRI visit are assessed as follows:

1. no episodes of asystole,

2. no occurrence of sustained ventricular arrhythmias in the bore,

3. no loss of capture due to rise in pacing threshold.

Outcome measures

Measure	ImageReady Pacemaker n=17 Participants patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit	0 number of MRI related patient adverse ev

Adverse Events

ImageReady Pacemaker

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	ImageReady Pacemaker n=20 participants at risk patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
Cardiac disorders atrial fibrillation	10.0% 2/20 • Number of events 3
Cardiac disorders coronary intervention	5.0% 1/20 • Number of events 1

Other adverse events

Measure	ImageReady Pacemaker n=20 participants at risk patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
Cardiac disorders paroxisma atrial fibrillation	5.0% 1/20 • Number of events 1

Additional Information

Giovanni Raciti

Guidant Europe SA/NV A Boston Scientific Company

Phone: +39 02 26983213

Email: giovanni.raciti@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place