Trial Outcomes & Findings for ProMRI Study of the Entovis Pacemaker System (Phase B) (NCT NCT02009696)

NCT ID: NCT02009696

Last Updated: 2015-11-25

Results Overview

Recruitment status

COMPLETED

Target enrollment

221 participants

Primary outcome timeframe

1 Month Post-MRI

Results posted on

2015-11-25

Participant Flow

Participant milestones

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 heart/chest or thoracic spine.
Overall Study STARTED	221
Overall Study COMPLETED	219
Overall Study NOT COMPLETED	2

Reasons for withdrawal

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 heart/chest or thoracic spine.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

ProMRI Study of the Entovis Pacemaker System (Phase B)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pacemaker Therapy n=221 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 heart/chest or thoracic spine.
Age, Continuous	68.4 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants
Sex: Female, Male Male	139 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Month Post-MRI

Outcome measures

Outcome measures
Measure	Pacemaker Therapy n=221 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 heart/chest or thoracic spine.
MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate	99.5 percentage of participants Interval 97.5 to 100.0

PRIMARY outcome

Timeframe: Between Pre-MRI and 1 Month Post-MRI

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

Evaluate the percentage of atrial pacing leads with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.

Outcome measures

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 heart/chest or thoracic spine.
Percentage of Participants Free of Atrial Pacing Threshold Rise	100 percentage of participants Interval 98.1 to 100.0

PRIMARY outcome

Timeframe: Between Pre-MRI and 1 Month Post-MRI

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

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

Outcome measures

Outcome measures
Measure	Pacemaker Therapy n=206 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 heart/chest or thoracic spine.
Percentage of Participants Free of Ventricular Pacing Threshold Rise	100 percentage of participants Interval 98.2 to 100.0

PRIMARY outcome

Timeframe: Between Pre-MRI and 1 Month Post-MRI

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

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

Outcome measures

Outcome measures
Measure	Pacemaker Therapy n=170 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 heart/chest or thoracic spine.
Percentage of Participants Free of P-wave Sensing Attenuation	98.2 percentage of participants Interval 94.9 to 99.6

PRIMARY outcome

Timeframe: Between Pre-MRI and 1 Month Post-MRI

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

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

Outcome measures

Outcome measures
Measure	Pacemaker Therapy n=188 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 heart/chest or thoracic spine.
Percentage of Participants Free of R-wave Sensing Attenuation	100 percentage of participants Interval 98.1 to 100.0

Adverse Events

Pacemaker Therapy

Serious events: 22 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pacemaker Therapy n=221 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 heart/chest or thoracic spine.
Cardiac disorders Angina	1.4% 3/221 • Number of events 3
Cardiac disorders Arrhythmia	1.4% 3/221 • Number of events 3
General disorders Cancer	0.45% 1/221 • Number of events 1
Cardiac disorders Coronary Artery Disease	0.90% 2/221 • Number of events 2
Gastrointestinal disorders Gastrointestinal	0.90% 2/221 • Number of events 2
General disorders Infection	0.45% 1/221 • Number of events 1
General disorders Medication Related	0.45% 1/221 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal	1.4% 3/221 • Number of events 3
Vascular disorders Peripheral Vascular Disease	0.45% 1/221 • Number of events 1
Cardiac disorders Syncope/Pre-Syncope	0.45% 1/221 • Number of events 1
Cardiac disorders Worsening Chronic Heart Failure	0.45% 1/221 • Number of events 1
General disorders General Disorders	2.7% 6/221 • Number of events 7

Other adverse events

Other adverse events
Measure	Pacemaker Therapy n=221 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 heart/chest or thoracic spine.
General disorders MRI Incidental Finding	17.2% 38/221 • Number of events 41

Additional Information

Clinical Studies Engineer

Biotronik, Inc.

Phone: 503-927-7230

Email: [email protected]

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