Trial Outcomes & Findings for ProMRI Study of the Iforia ICD System (Phase C) (NCT NCT02096692)

NCT ID: NCT02096692

Last Updated: 2016-02-29

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 154 participants
• Primary outcome timeframe: 1 Month Post-MRI
• Results posted on: 2016-02-29

Participant Flow

Participant milestones

Measure	ICD System Therapy Patients with a ProMRI ICD System Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine
Overall Study STARTED	154
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ProMRI Study of the Iforia ICD System (Phase C)

Baseline characteristics by cohort

Measure	ICD System Therapy n=154 Participants Patients with a ProMRI ICD System Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine
Age, Continuous	60.0 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	119 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Month Post-MRI

Outcome measures

Measure	ICD System Therapy n=154 Participants Patients with a ProMRI ICD System Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine
MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate	100 percentage of participants Interval 97.6 to 100.0

PRIMARY outcome

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

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

Outcome measures

Measure	ICD System Therapy n=154 Participants Patients with a ProMRI ICD System Patients with a ProMRI ICD System: Tachycardia Fast 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 97.6 to 100.0

PRIMARY outcome

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

Population: All participants who had measurable R-waves at both pre-MRI and and 1 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	ICD System Therapy n=153 Participants Patients with a ProMRI ICD System Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine
Percentage of Participants Free of R-wave Sensing Attenuation	99.3 percentage of participants Interval 96.4 to 100.0

Adverse Events

ICD System Therapy

Serious events: 23 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	ICD System Therapy n=154 participants at risk Patients with a ProMRI ICD System Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine
Cardiac disorders Angina	0.65% 1/154 • Number of events 1
Cardiac disorders Arrhythmia	1.3% 2/154 • Number of events 2
Cardiac disorders Cardiac Arrest	0.65% 1/154 • Number of events 1
General disorders Infection	3.9% 6/154 • Number of events 6
Infections and infestations Influenza	0.65% 1/154 • Number of events 1
General disorders Sinus Thrombosis	0.65% 1/154 • Number of events 1
General disorders Medication Related	1.9% 3/154 • Number of events 3
Musculoskeletal and connective tissue disorders Musculoskeletal Pain or Injury	2.6% 4/154 • Number of events 4
Vascular disorders Peripheral Vascular Disease	0.65% 1/154 • Number of events 1
Psychiatric disorders Depression	0.65% 1/154 • Number of events 1
Renal and urinary disorders Renal Failure	0.65% 1/154 • Number of events 1
Respiratory, thoracic and mediastinal disorders Obstructive Sleep Apnea	0.65% 1/154 • Number of events 1
Nervous system disorders Stroke	0.65% 1/154 • Number of events 1
Cardiac disorders Syncope/Pre-Syncope	0.65% 1/154 • Number of events 1
Cardiac disorders Worsening Chronic Heart Failure	5.8% 9/154 • Number of events 12
Respiratory, thoracic and mediastinal disorders Dyspnea	0.65% 1/154 • Number of events 1

Other adverse events

Measure	ICD System Therapy n=154 participants at risk Patients with a ProMRI ICD System Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine
General disorders MRI Incidental Finding	15.6% 24/154 • Number of events 25

Additional Information

Clinical Studies Engineer

Biotronik, Inc.

Phone: 503-451-8049

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