Trial Outcomes & Findings for ProMRI Study of the Entovis Pacemaker System (NCT NCT01761162)

NCT ID: NCT01761162

Last Updated: 2017-02-09

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 229 participants
• Primary outcome timeframe: 1 Month Post-MRI
• Results posted on: 2017-02-09

Participant Flow

Participant milestones

Measure	Pacemaker Therapy Patients with a ProMRI Pacemaker System Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.
Overall Study STARTED	229
Overall Study COMPLETED	226
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Pacemaker Therapy Patients with a ProMRI Pacemaker System Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

ProMRI Study of the Entovis Pacemaker System

Baseline characteristics by cohort

Measure	Pacemaker Therapy n=229 Participants Patients with a ProMRI Pacemaker System Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.
Age, Continuous	71.2 years STANDARD_DEVIATION 10.7 • n=5 Participants
Gender Female	71 Participants n=5 Participants
Gender Male	158 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Month Post-MRI

Outcome measures

Measure	Pacemaker Therapy n=229 Participants Patients with a ProMRI Pacemaker System Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.
MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate	100 percentage of participants Interval 98.4 to 100.0

PRIMARY outcome

Timeframe: Pre-MRI, 1 Month Post-MRI

Population: Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.

Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.

Outcome measures

Measure	Pacemaker Therapy n=191 Participants Patients with a ProMRI Pacemaker System Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.
Percentage of Participants Free of Atrial Pacing Threshold Rise	99.0 percentage of participants Interval 96.3 to 99.9

PRIMARY outcome

Timeframe: Pre-MRI, 1 Month Post-MRI

Population: Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.

Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.

Outcome measures

Measure	Pacemaker Therapy n=217 Participants Patients with a ProMRI Pacemaker System Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.
Percentage of Participants Free of Ventricular Pacing Threshold Rise	100 percentage of participants Interval 98.3 to 100.0

PRIMARY outcome

Timeframe: Pre-MRI, 1 Month Post-MRI

Population: Number of participants with an atrial lead and same atrial sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.

Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.

Outcome measures

Measure	Pacemaker Therapy n=168 Participants Patients with a ProMRI Pacemaker System Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.
Percentage of Participants Free of P-wave Sensing Attenuation	99.4 percentage of participants Interval 96.7 to 100.0

PRIMARY outcome

Timeframe: Pre-MRI, 1 Month Post-MRI

Population: Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.

Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.

Outcome measures

Measure	Pacemaker Therapy n=194 Participants Patients with a ProMRI Pacemaker System Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.
Percentage of Participants Free of R-wave Sensing Attenuation	99.5 percentage of participants Interval 97.2 to 100.0

Adverse Events

Pacemaker Therapy

Serious events: 21 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pacemaker Therapy n=229 participants at risk Patients with a ProMRI Pacemaker System Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.
Cardiac disorders Angina	0.87% 2/229 • Number of events 2
Cardiac disorders Arrhythmia	0.87% 2/229 • Number of events 2
Vascular disorders Arterial Stenosis	0.87% 2/229 • Number of events 2
Vascular disorders Coronary Artery Disease	1.3% 3/229 • Number of events 3
Gastrointestinal disorders Gastrointestinal	0.44% 1/229 • Number of events 1
Infections and infestations Infection	0.87% 2/229 • Number of events 2
Vascular disorders Myocardial Infarction	0.44% 1/229 • Number of events 1
General disorders Mild to moderate post-operative risks	0.87% 2/229 • Number of events 2
Musculoskeletal and connective tissue disorders Musculoskeletal	0.87% 2/229 • Number of events 3
Respiratory, thoracic and mediastinal disorders Respiratory	0.44% 1/229 • Number of events 1
Musculoskeletal and connective tissue disorders Spinal Stenosis	0.44% 1/229 • Number of events 1
Vascular disorders Stroke	0.44% 1/229 • Number of events 1
Vascular disorders Syncope/Pre-Syncope	1.3% 3/229 • Number of events 5

Other adverse events

Measure	Pacemaker Therapy n=229 participants at risk Patients with a ProMRI Pacemaker System Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back.
Cardiac disorders Arrythmia	5.7% 13/229 • Number of events 14
General disorders MRI Incidental Finding	7.4% 17/229 • Number of events 17

Additional Information

Clinical Studies Engineer

Biotronik, Inc.

Phone: 503-927-7230

Email: justin.michalski@biotronik.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigators agree to submit copies of any manuscript proposed for publication to Sponsor for review at least 30 days in advance of submission for publication or presentation. Sponsor may extend such review period for another 90 days to file patent applications or take other steps to protect its intellectual property interests, or to remove from the paper or presentation any language that is detrimental to Sponsor's intellectual property interests.
• Publication restrictions are in place

Restriction type: OTHER