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Trial record 1 of 1 for:    NCT01761162
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ProMRI Study of the Entovis Pacemaker System

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ClinicalTrials.gov Identifier: NCT01761162
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : November 4, 2014
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Interventions Device: Patients with a ProMRI Pacemaker System
Other: Magnetic Resonance Imaging (MRI) scan
Enrollment 229
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pacemaker Therapy
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 229
Completed 226
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title Pacemaker Therapy
Hide Arm/Group Description

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 Number of Baseline Participants 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 229 participants
71.2  (10.7)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants
Female
71
  31.0%
Male
158
  69.0%
1.Primary Outcome
Title MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate
Hide Description [Not Specified]
Time Frame 1 Month Post-MRI
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pacemaker Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 229
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(98.4 to 100)
2.Primary Outcome
Title Percentage of Participants Free of Atrial Pacing Threshold Rise
Hide Description Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.
Time Frame Pre-MRI, 1 Month Post-MRI
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.
Arm/Group Title Pacemaker Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.0
(96.3 to 99.9)
3.Primary Outcome
Title Percentage of Participants Free of Ventricular Pacing Threshold Rise
Hide Description Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Time Frame Pre-MRI, 1 Month Post-MRI
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.
Arm/Group Title Pacemaker Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 217
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(98.3 to 100)
4.Primary Outcome
Title Percentage of Participants Free of P-wave Sensing Attenuation
Hide Description Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Time Frame Pre-MRI, 1 Month Post-MRI
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants with an atrial lead and same atrial sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.
Arm/Group Title Pacemaker Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 168
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.4
(96.7 to 100)
5.Primary Outcome
Title Percentage of Participants Free of R-wave Sensing Attenuation
Hide Description Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Time Frame Pre-MRI, 1 Month Post-MRI
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.
Arm/Group Title Pacemaker Therapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 194
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.5
(97.2 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pacemaker Therapy
Hide Arm/Group Description

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.

All-Cause Mortality
Pacemaker Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pacemaker Therapy
Affected / at Risk (%) # Events
Total   21/229 (9.17%)    
Cardiac disorders   
Angina   2/229 (0.87%)  2
Arrhythmia   2/229 (0.87%)  2
Gastrointestinal disorders   
Gastrointestinal   1/229 (0.44%)  1
General disorders   
Mild to moderate post-operative risks   2/229 (0.87%)  2
Infections and infestations   
Infection   2/229 (0.87%)  2
Musculoskeletal and connective tissue disorders   
Musculoskeletal   2/229 (0.87%)  3
Spinal Stenosis   1/229 (0.44%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory   1/229 (0.44%)  1
Vascular disorders   
Arterial Stenosis   2/229 (0.87%)  2
Coronary Artery Disease   3/229 (1.31%)  3
Myocardial Infarction   1/229 (0.44%)  1
Stroke   1/229 (0.44%)  1
Syncope/Pre-Syncope   3/229 (1.31%)  5
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pacemaker Therapy
Affected / at Risk (%) # Events
Total   30/229 (13.10%)    
Cardiac disorders   
Arrythmia   13/229 (5.68%)  14
General disorders   
MRI Incidental Finding   17/229 (7.42%)  17
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Clinical Studies Engineer
Organization: Biotronik, Inc.
Phone: 503-927-7230
Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT01761162     History of Changes
Other Study ID Numbers: G120226
First Submitted: January 2, 2013
First Posted: January 4, 2013
Results First Submitted: October 28, 2014
Results First Posted: November 4, 2014
Last Update Posted: February 9, 2017