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The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRIâ„¢ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment. The study consisted of two phases, a Lead Safety Phase which evaluated the safety of the Tendril MRI lead, and an MRI Phase which evaluated the safety and efficacy of the Accent MRI pacemaker system in an MRI environment.
The safety and efficacy of the Accent MRI pacemaker and Tendril MRI lead will be evaluated as described below:
Lead Safety Safety of the Tendril MRIâ„¢ lead will be evaluated in terms of freedom from right atrial (RA) and right ventricle (RV) lead-related complications at implant to 2 months (acute timeframe), and at the 2 through the 12 month visit (chronic timeframe).
MRI Safety The safety of the Accent MRIâ„¢ system will be evaluated in terms of freedom from MRI scan related complications in the month following the MRI scan.
Lead Efficacy Efficacy of the Tendril MRIâ„¢ lead will be evaluated in terms of the change in atrial and ventricular capture and sensing thresholds before and after the MRI scan.
MRI Efficacy Efficacy of the Tendril MR lead will be evaluated in terms of the change in bipolar atrial and ventricular capture and sensing thresholds before and after the MRI scan.
Secondary Endpoints Safety Safety of the Accent MRIâ„¢ system will be evaluated in terms of freedom from system-related complications through the 12 month visit.
Efficacy Efficacy of the Tendril MRIâ„¢ lead will be evaluated in terms of the atrial and ventricular capture thresholds at the MRI Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lead Safety | Experimental | Patient implanted with an Accent MRI system to evaluate safety of the Tendril MRI lead |
|
| Accent MRI system MRI Scan Group | Experimental | Patient implanted with an Accent MRI system will receive an MRI scan to evaluate safety and efficacy of the Accent MRI system in an MRI environment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accent MRI system (lead safety) | Device | Patients implanted with an Accent MRI system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period | Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit | Implant through 2 months |
| Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period | Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit | Implant through 2 months |
| Freedom From RA Related Complications in the Chronic Period | Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit | 2 months through 12 months |
| Freedom From Right Ventricular Lead Related Complications in the Chronic Period | Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit | 2 months through 12 months |
| Freedom From MRI Scan-related Complications | Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit | MRI Scan visit through 1 month after MRI scan visit |
| Change in Atrial Capture Threshold From Pre to Post MRI Scan | Percentage of patients with an increase in RA capture thresholds of <= 0.5 V, at a pulse width of 0.5 ms . | MRI Scan visit to 1 month after MRI scan visit |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From System-related Complications | Percentage of patients who do not have system-related complications from implant through the 12 month study visit | Implant through 12 months |
| Atrial Capture Threshold at the MRI Visit |
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Inclusion Criteria:
Eligible patients will meet all of the following:
Exclusion Criteria:
Patients will be excluded if they meet any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Grant Kim | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Heart Center Research |
The MRI phase was originally designed as a randomized study, with MRI and control groups, but due to challenges encountered with patient recruitment, it was later changed to a non-randomized study.
Lead safety phase: enrollment began on 03-30-2012 and ended on 06-18-2013; enrollment occured at 68 sites and 920 patients were enrolled.
MRI Phase: study was approved by FDA on 03-26-2014. 255 patients were enrolled into the MRI Phase. 181 scans were completed by the 10-30-2014 cut-off date: 151 in the US, and 30 supplemental scans in Australia. The patients enrolled in the US came from the lead safety phase, the supplemental scans in Australia did not participate in lead safety phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lead Safety Phase | Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRIâ„¢ lead and Accent MRIâ„¢ pacemaker. |
| FG001 | MRI Safety Phase |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Lead Safety |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 10, 2014 |
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| Accent MRI system (with MRI scan) | Device | Patients implanted with an Accent MRI system will receive an MRI scan |
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| Change in Ventricular Capture Threshold Pre to Post MRI Scan |
Percentage of patients with an increase in RV capture thresholds of <=0.5V, at a pulse width of 0.5 ms. |
| MRI Scan visit to 1 month after MRI scan visit |
| Change in Atrial Sense Amplitude | Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV. | MRI Scan visit to 1 month after MRI scan visit |
| Change in Ventricular Sense Amplitude | Percentage of patients with an reduction in RV sense amplitude <=50% and sense amplitude >=5 mV. | MRI Scan visit to 1 month after the MRI Scan visit |
Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit
| MRI Scan visit (approx 3 months post implant) |
| Ventricular Capture Threshold at the MRI Visit | Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit | MRI Scan visit (approx 3 months post implant) |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Arizona Arrhythmia Research Center | Phoenix | Arizona | 85016 | United States |
| Baptist Health Medical Center | Little Rock | Arkansas | 72205 | United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Mercy Hospital Northwest Arkansas | Rogers | Arkansas | 72758 | United States |
| Central Cardiology | Bakersfield | California | 93308 | United States |
| Raymond Schaerf, MD | Burbank | California | 91505 | United States |
| John Muir Medical Center | Concord | California | 94520 | United States |
| St. Jude Hospital | Fullerton | California | 92835 | United States |
| Glendale Adventist Medical Center | Glendale | California | 91206 | United States |
| Scripps Green Hospital | La Jolla | California | 92037 | United States |
| Memorial Medical Center | Modesto | California | 95355 | United States |
| Premier Cardiology, Inc / Hoag Hospital | Newport Beach | California | 92629 | United States |
| Desert Cardiology Consultants | Rancho Mirage | California | 92270 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| Sutter Memorial Hospital | Sacramento | California | 95819 | United States |
| Aurora Denver Cardiology Associates | Denver | Colorado | 80012 | United States |
| South Denver Cardiology Associates PC | Littleton | Colorado | 80120 | United States |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | United States |
| Medical Specialists of the Palm Beaches | Atlantis | Florida | 33462 | United States |
| Watson Clinic Center | Lakeland | Florida | 33647 | United States |
| Florida Hospital Orlando | Orlando | Florida | 32803 | United States |
| Orlando Health | Orlando | Florida | 32806 | United States |
| Brevard Cardiovascular Research Associates | Rockledge | Florida | 32955 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| University of South Florida, Cardiovascular Services | Tampa | Florida | 33606 | United States |
| Athens Cardiology Group, PC | Athens | Georgia | 30606 | United States |
| Atlanta Heart Specialist | Atlanta | Georgia | 30041 | United States |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62701 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Thoracic Cardio Healthcare Foundation | Lansing | Michigan | 48910 | United States |
| Providence Hospital | Southfield | Michigan | 48075 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Alegent Creighton Health | Omaha | Nebraska | 68124 | United States |
| University of Rochester Medical Center | Rochester | New York | 14450 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7075 | United States |
| Mid Carolina Cardiology | Charlotte | North Carolina | 28204 | United States |
| Wake Forest University Medical Center Clinical Sciences | Winston-Salem | North Carolina | 27615 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Columbus Cardiovascular Associates | Columbus | Ohio | 43213 | United States |
| EMH Regional Medical Center | Elyria | Ohio | 44035 | United States |
| St. Elizabeth Health Center | Youngstown | Ohio | 44501 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Oklahoma Heart Institute at Utica | Tulsa | Oklahoma | 73112 | United States |
| Abington Medical Specialists | Abington | Pennsylvania | 72758 | United States |
| Allegheny Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| Donald Guthrie Foundation for Education and Research | Sayre | Pennsylvania | 18840 | United States |
| York Hospital | York | Pennsylvania | 17403 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29401 | United States |
| PMG Research of Charleston, LLC | Charleston | South Carolina | 29406 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| South Texas Cardiovascular Consultants | San Antonio | Texas | 78201 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| Martha Jefferson Hospital | Charlottesville | Virginia | 22911 | United States |
| Virginia Cardiovascular Associates, PC | Manassas | Virginia | 20109 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Kitsap Cardiology Consultants | Bremerton | Washington | 98310 | United States |
| The Heart Institute at Virginia Mason | Seattle | Washington | 98101 | United States |
| Aurora Medical Group | Milwaukee | Wisconsin | 14450 | United States |
| St. Andrews Hospital | Adelaide | South Australia | 5000 | Australia |
| Cliniques Universitaires Saint Luc | Brussels | B CAP R | 1200 | Belgium |
| Kuopio University Hospital | Kuopio | East Finland | 70211 | Finland |
| Diakonessenhuis Utrecht | Utrecht | 3582 KE | Netherlands |
A subset of patients enrolled in the Lead safety phase underwent an elective MRI scan to evaluate the safety and efficacy of Accent MRI system within the MRI environment.
| COMPLETED |
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| NOT COMPLETED |
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| MRI Safety |
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A subset of participants from the lead safety phase (225) were included in the "MRI Phase." 30 supplemental scans were performed in Australia for a total of 255 participants in the MRI Phase. Each Phase was analyzed separately.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lead Safety Phase | Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRIâ„¢ lead and Accent MRIâ„¢ pacemaker. |
| BG001 | MRI Phase | A subset of patients enrolled in the Lead safety phase (225 subjects from lead safety phase) underwent an elective MRI scan to evaluate the safety and efficacy of Accent MRI system within the MRI environment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Each phase was analyzed separately. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Each phase was analyzed separately. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Each phase was analyzed separately | Analysis for lead safety and MRI safety phases was done separately. | Count of Participants | Participants |
| ||||||||||||||
| Race (NIH/OMB) | Each phase was analyzed separately | Analysis for lead safety and MRI safety phases was done separately. | Count of Participants | Participants |
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| Region of Enrollment | Region of enrollment lead safety phase. Each phase of the study was analyzed separately | Region of enrollment for lead safety phase only. Each phase of the study was analyzed separately | Number | participants |
| ||||||||||||||
| Region of Enrollment | Region of enrollment MRI safety phase. Each phase of the study was analyzed separately | Region of enrollment for MRI safety phase only. Each phase of the study was analyzed separately | Number | participants |
| ||||||||||||||
| Primary Indication for Pacemaker Implant | Each phase was analyzed separately. | Count of Participants | Participants |
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| Cardiovascular History | Each phase was analyzed separately | Count of Participants | Participants |
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| Prior Cardiac Interventions | Each phase was analyzed separately | Count of Participants | Participants |
| |||||||||||||||
| Non-Ventricular Arrhythmia History | Each phase was analyzed separately | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period | Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit | 99 of the 920 enrolled subjects had no RA lead and hence did not contribute any data towards this endpoint. | Posted | Number | 95% Confidence Interval | percentage of subjects | Implant through 2 months |
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| Primary | Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period | Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit | one of 920 enrolled subjects did not have an RV lead implanted. | Posted | Number | 95% Confidence Interval | percentage of subjects | Implant through 2 months |
|
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| Primary | Freedom From RA Related Complications in the Chronic Period | Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit | Data from 114 subjects were unavailable for this endpoint analysis due to the following reasons: no RA lead: 99; death: 8; unsuccessful implant: 2; withdrawal:5. | Posted | Number | 95% Confidence Interval | percentage of subjects | 2 months through 12 months |
|
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| Primary | Freedom From Right Ventricular Lead Related Complications in the Chronic Period | Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit | Data from 18 subjects were unavailable for this endpoint analysis due to the following reasons: no RV lead: 1; death: 9; unsuccessful implant: 2; withdrawal: 6. | Posted | Number | 95% Confidence Interval | percentage of subjects | 2 months through 12 months |
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| Primary | Freedom From MRI Scan-related Complications | Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit | 151 of the 255 patients enrolled received an MRI scan. An additional 30 scans were performed using an identical scan protocol implemented in this study, for a total of 181 patients who underwent an MRI scan. | Posted | Number | 95% Confidence Interval | percentage of subjects | MRI Scan visit through 1 month after MRI scan visit |
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| Primary | Change in Atrial Capture Threshold From Pre to Post MRI Scan | Percentage of patients with an increase in RA capture thresholds of <= 0.5 V, at a pulse width of 0.5 ms . | 37 of the 181 subjects that underwent a MRI scan did not have RA capture threshold data at 1-month post scan; no RA lead: 10; RA lead off: 3; atrial fibrillation (AF/AFl) during measurement: 10; 1-month visit not completed: 14. | Posted | Number | 95% Confidence Interval | percentage of subjects | MRI Scan visit to 1 month after MRI scan visit |
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| Primary | Change in Ventricular Capture Threshold Pre to Post MRI Scan | Percentage of patients with an increase in RV capture thresholds of <=0.5V, at a pulse width of 0.5 ms. | 167 of the 181 subjects with an MRI scan had completed the 1-month post MRI visit. Data from 167 subjects was available for this analysis; 13 subjects had not completed 1 month follow-up, 1 subject had RV capture threshold missing or not done. | Posted | Number | 95% Confidence Interval | percentage of subjects | MRI Scan visit to 1 month after MRI scan visit |
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| Primary | Change in Atrial Sense Amplitude | Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV. | 60 of the 181 subjects that underwent an MRI scan did not have RA sense amplitude data: no RA lead: 10; RA lead off: 3; AF/AFl/ heart rate< 30 bpm/ no P-wave during measurement: 11; P-wave < 1.5 mV: 23; 1-month visit not yet completed: 12; AF/AFl during 1-month measurement: 1 | Posted | Number | 95% Confidence Interval | percentage of subjects | MRI Scan visit to 1 month after MRI scan visit |
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| Primary | Change in Ventricular Sense Amplitude | Percentage of patients with an reduction in RV sense amplitude <=50% and sense amplitude >=5 mV. | 47 of 181 subjects that underwent an MRI scan did not have RV sense amplitude: no R-wave/HR < 30 beats per minute (BPM): 18; R-wave amplitude < 5 mV: 18; one-month visit not completed: 11. 134 subjects were available for evaluation of endpoint. | Posted | Number | 95% Confidence Interval | percentage of subjects | MRI Scan visit to 1 month after the MRI Scan visit |
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| Secondary | Freedom From System-related Complications | Percentage of patients who do not have system-related complications from implant through the 12 month study visit | All subjects enrolled in the lead-safety arm. | Posted | Number | 95% Confidence Interval | percentage of subjects | Implant through 12 months |
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| Secondary | Atrial Capture Threshold at the MRI Visit | Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit | 23 of the 181 subjects that underwent an MRI scan did not have RA capture threshold for the MRI scan visit: no RA lead: 10; RA lead off: 3; AF/AFl during measurement: 10. | Posted | Number | 95% Confidence Interval | percentage of subjects | MRI Scan visit (approx 3 months post implant) |
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| Secondary | Ventricular Capture Threshold at the MRI Visit | Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit | All subjects that underwent a MRI scan had ventricular capture threshold data available. | Posted | Number | 95% Confidence Interval | percentage of subjects | MRI Scan visit (approx 3 months post implant) |
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5 years
Adverse events (AEs) are classified as complications, observations, or other reported events. An independent, Clinical Events Committee, adjudicated all adverse events reported during the MRI Study.
Complications: AEs that require invasive intervention.
Observations: AEs that can be managed without invasive intervention.
Other Reported Events (ORE): Any other clinical event, which is not caused/associated with the study system component(s) and/or defined as an AE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lead Safety Phase | Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRIâ„¢ lead and Accent MRIâ„¢ pacemaker. | 132 | 920 | 70 | 920 | 60 | 920 |
| EG001 | MRI Phase | Evaluate the safety and efficacy of the St. Jude Medical Accent MRI system, which includes the Tendril MRIâ„¢ lead and Accent MRIâ„¢ pacemaker, within the MRI environment. | 0 | 255 | 0 | 255 | 1 | 255 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RA Lead Related: Lead Dislodgement or Migration | Product Issues | MedDRA | Systematic Assessment |
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| RA Lead Related: Elevated Pacing Thresholds | Product Issues | MedDRA | Systematic Assessment |
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| RA Lead Related: Cardiac Perforation | Product Issues | MedDRA | Systematic Assessment |
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| RA Lead Related: Lead Fracture | Product Issues | MedDRA | Systematic Assessment |
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| RA Lead Related: Undersensing | Product Issues | MedDRA | Systematic Assessment |
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| RV Lead Related: Lead Dislodgement or Migration | Product Issues | MedDRA | Systematic Assessment |
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| RV Lead Related: Elevated Pacing Thresholds | Product Issues | MedDRA | Systematic Assessment |
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| VR Lead Related: Lead Fracture | Product Issues | MedDRA | Systematic Assessment |
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| RV Lead Related: Loss of Capture | Product Issues | MedDRA | Systematic Assessment |
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| RV Lead Related: Extracardiac Stimulation | Product Issues | MedDRA | Systematic Assessment |
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| RV Lead Related: Twiddler's Syndrome | General disorders | MedDRA | Systematic Assessment |
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| Pacemaker Related: Device Connectivity Issue | Product Issues | MedDRA | Systematic Assessment |
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| Pacemaker Related: Early Battery Depletion | Product Issues | MedDRA | Systematic Assessment |
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| System Related: Cardiac Tamponade | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| System Related: Decompensated HF | Cardiac disorders | MedDRA | Systematic Assessment |
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| System Related: Infection | Infections and infestations | MedDRA | Systematic Assessment |
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| System Related: Pacemaker Induced Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
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| System Related: Cardiac Perforation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| System Related: Pacemaker system relocation to right side | General disorders | MedDRA | Systematic Assessment |
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| System Related: Pericardial Effusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedure Related: Pneumothorax | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedure Related: Infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Procedure Related: Bleeding/Hematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedure Related: Pocket Site/Incision Pain Lasting Greater Than 72 Hours Post Implant | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedure Related: Insufficient Slack in Lead | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedure Related: Device Migration | Product Issues | MedDRA | Systematic Assessment |
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| Procedure Related: Hemoptysis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedure Related: Hemothorax | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedure Related: Pericardial Effusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedure Related: Stenosis of The Left Subclavian Vein | Vascular disorders | MedDRA | Systematic Assessment |
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| Procedure Related: Thrombo-Embolic Event | Vascular disorders | MedDRA | Systematic Assessment |
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| Procedure Related: Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RA Lead Related: Oversensing | Product Issues | MedDRA | Systematic Assessment |
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| Pacemaker Related: Pacemaker Mediated Tachycardia | General disorders | MedDRA | Systematic Assessment |
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| Procedure Related: Bleeding/Hematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedure Related: Pneumothorax | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Procedure Related: Thrombo-Embolic Event | Vascular disorders | MedDRA | Systematic Assessment |
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| ORE: Atrial Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
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| ORE: Decompensated HF | Cardiac disorders | MedDRA | Systematic Assessment |
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| ORE: Ventricular Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
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| ORE: Chest Pain | Cardiac disorders | MedDRA | Systematic Assessment |
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| ORE: Cerebrovascular Accident | Vascular disorders | MedDRA | Systematic Assessment |
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| ORE: Angina | Cardiac disorders | MedDRA | Systematic Assessment |
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| ORE: Syncope | Cardiac disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grant Kim, Program Director - Traditional Cardiac Rhythm Management | Abbott | 818-493-3147 | grant.kim1@abbott.com |
| Aug 16, 2019 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Has not yet completed MRI scan |
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| MRI scan not performed at MRI visit |
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| Age - MRI Safety Phase |
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| Sex - MRI Safety Phase |
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| MRI Safety Phase |
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| MRI Safety Phase |
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| Australia |
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| MRI Safety Phase |
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| MRI Safety Phase |
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| MRI Safety Phase |
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| Paroxysmal AF - MRI safety |
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| Permanent AF - lead safety |
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| Permanent AF - MRI safety |
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| Persistent AF - lead safety |
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| Persistent AF - MRI safety |
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| Atrial Flutter - lead safety |
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| Atrial Flutter - MRI safety |
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| Atrial Tachycardia - lead safety |
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| Atrial Tachycardia - MRI safety |
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| Supra Ventricular - lead safety |
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| Supra Ventricular - MRI safety |
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| None - lead safety |
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| None - MRI safety |
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| Title | Denominators | Categories | ||||
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