Trial Outcomes & Findings for Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (NCT NCT03075215)
NCT ID: NCT03075215
Last Updated: 2023-10-25
Results Overview
The traditional outcome of interest when using the Clinical Composite Score (CCS) is the proportion of patients who improved. Improvement was defined as remaining alive and free of heart failure hospitalization while also demonstrating improvement in NYHA Class, patient Global Assessment, or both. Patients were considered worsened if they died, experienced a heart failure hospitalization, or had worsened NYHA Class or patient Global Assessment. Patients who neither improved nor worsened were classified as "no change."
Recruitment status
COMPLETED
Target enrollment
2044 participants
Primary outcome timeframe
12 months
Results posted on
2023-10-25
Participant Flow
In total 2044 subjects were enrolled into the study which included 103 PMCF subjects. For 9 of those subjects (PMCF = 4) the data could not be used and 30 subjects were consent ineligible.
Participant milestones
| Measure |
Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.
Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up.
|
|---|---|
|
12-Month Primary Endpoint
STARTED
|
2005
|
|
12-Month Primary Endpoint
COMPLETED
|
1586
|
|
12-Month Primary Endpoint
NOT COMPLETED
|
419
|
|
Post Market Clinical Follow-Up ONLY
STARTED
|
103
|
|
Post Market Clinical Follow-Up ONLY
COMPLETED
|
63
|
|
Post Market Clinical Follow-Up ONLY
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.
Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up.
|
|---|---|
|
12-Month Primary Endpoint
Death
|
152
|
|
12-Month Primary Endpoint
Withdrawal by Subject
|
267
|
|
Post Market Clinical Follow-Up ONLY
Death
|
15
|
|
Post Market Clinical Follow-Up ONLY
Withdrawal by Subject
|
25
|
Baseline Characteristics
Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry
Baseline characteristics by cohort
| Measure |
Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.
n=2005 Participants
Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up.
|
|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
462 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1543 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1230 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
86 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race Not Disclosed
|
672 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Subjects must have a complete composite score at 12 months of follow up
The traditional outcome of interest when using the Clinical Composite Score (CCS) is the proportion of patients who improved. Improvement was defined as remaining alive and free of heart failure hospitalization while also demonstrating improvement in NYHA Class, patient Global Assessment, or both. Patients were considered worsened if they died, experienced a heart failure hospitalization, or had worsened NYHA Class or patient Global Assessment. Patients who neither improved nor worsened were classified as "no change."
Outcome measures
| Measure |
Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.
n=1558 Participants
Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up.
|
|---|---|
|
CRT Response Rate
Improved
|
918 Participants
|
|
CRT Response Rate
No Change
|
312 Participants
|
|
CRT Response Rate
Worsened
|
328 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: A total of 103 subjects were classified as NG4 PMCF subjects at time of enrollment, among them 4 subjects data sets were not cleaned and unable to get corrected upon the end of the study. The final analyzed count is 99 subjects.
Complication Free rate. PG-related Complication is defined as those detectable adverse events that resulted in: * Death * Serious injury * Correction of PG failure requiring invasive intervention * Permanent loss of PG device function. Permanent loss of device function is defined as any Pulse Generator (PG) that reverts to Safety Core or any PG rendered unable to deliver pacing or shocks Complications that are determined to be associated with the PG will be considered PGrelated complications (PG) and count against the PMCF endpoint. Complications related to the LV, RV, RA leads will not be counted against the PMCF endpoint.
Outcome measures
| Measure |
Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.
n=99 Participants
Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up.
|
|---|---|
|
Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications
|
97.9 % of participants
|
Adverse Events
Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.
Serious events: 575 serious events
Other events: 132 other events
Deaths: 152 deaths
Serious adverse events
| Measure |
Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.
n=2015 participants at risk
Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up. Any reportable adverse events (including deaths) from these 103 subjects, are represented in the mortality and adverse event sections of the results.
|
|---|---|
|
Blood and lymphatic system disorders
Hematological
|
0.45%
9/2015 • Number of events 11 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Aortic Regurgitation
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Aortic Stenosis
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Arrhythmia-Other
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
2.1%
43/2015 • Number of events 43 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Atrial Flutter
|
0.50%
10/2015 • Number of events 10 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Cardiac Arrest
|
0.65%
13/2015 • Number of events 13 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Cardiac Medication Complication - Heart Failure
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Cardiogenic Shock
|
0.50%
10/2015 • Number of events 10 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Chest Pain - Heart Failure
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
1.8%
36/2015 • Number of events 40 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Gastrointestinal - Heart Failure
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Heart Failure Patient Condition - Cardiovascular - OTHER
|
0.45%
9/2015 • Number of events 9 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Heart Failure Symptoms - Unspecified
|
3.1%
63/2015 • Number of events 74 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Hypotension - Heart Failure
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Incessant VT/ VT Storm
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Intracardiac thrombus
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Mitral Regurgitation
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Multi-system Failure - Heart Failure
|
0.30%
6/2015 • Number of events 6 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Multiple Heart Failure Symptoms
|
4.2%
84/2015 • Number of events 108 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Nonsustained ventricular tachycardia (NSVT)
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Palpitations
|
0.25%
5/2015 • Number of events 6 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Patient Condition - Cardiovascular - OTHER
|
0.25%
5/2015 • Number of events 6 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Pericardial effusion - unrelated procedure/device
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Peripheral edema - Heart Failure
|
0.30%
6/2015 • Number of events 6 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Pleural Effusion - Heart Failure
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Premature Ventricular Contractions (PVC)
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Pulmonary Edema - Heart Failure
|
0.30%
6/2015 • Number of events 6 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Pulseless Electrical Activity (PEA)
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Renal Failure/Insufficiency - Heart Failure
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Syncope - Heart Failure
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Valvular Damage/Valvular insufficiency
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Ventricular Fibrillation (VF)
|
0.45%
9/2015 • Number of events 10 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
1.3%
27/2015 • Number of events 40 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Endocrine disorders
Endocrine
|
0.40%
8/2015 • Number of events 8 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Gastrointestinal disorders
Gastrointestinal
|
1.5%
30/2015 • Number of events 44 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Adverse Reaction - Medication
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Chest Pain - Other
|
0.35%
7/2015 • Number of events 7 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Death
|
1.7%
34/2015 • Number of events 34 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Dizziness
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Fatigue/Weakness
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
0.15%
3/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Multi-System Failure
|
0.25%
5/2015 • Number of events 5 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Multiple Symptoms
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Patient Condition - Non-Cardiovascular - OTHER
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Physical Trauma
|
0.84%
17/2015 • Number of events 19 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Syncope
|
0.30%
6/2015 • Number of events 6 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Immune system disorders
Immune
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Infections and infestations
Fever and/or Virus
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Infections and infestations
Infection (> 30 days post implant)
|
0.50%
10/2015 • Number of events 10 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Infections and infestations
Localized Infection
|
0.35%
7/2015 • Number of events 8 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Infections and infestations
System Infection
|
0.99%
20/2015 • Number of events 22 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Hematoma - pocket (≤ 30 days post-implant)
|
0.20%
4/2015 • Number of events 5 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Post Surgical wound discomfort/bruising/swelling
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Post -Surgical infection (≤ 30 days post implant)
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Post-surgical pocket hemorrhage/bleeding/drainage
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Procedure - PG System - Other
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Unrelated procedure/device - OTHER
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Venous occlusion
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.55%
11/2015 • Number of events 12 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.74%
15/2015 • Number of events 22 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Nervous system disorders
Neurological
|
0.74%
15/2015 • Number of events 15 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Conductor Coil Fracture - RA
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Conductor Coil Fracture - RV
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Elevated Threshold - RA
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Elevated threshold - LV
|
0.15%
3/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Elevated threshold - RV
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Extracardiac stimulation - LV
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Extracardiac stimulation - RV
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Multiple signs - LV
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Multiple signs - RV
|
0.10%
2/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Multiple signs- RA
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - No reported signs - LV
|
0.30%
6/2015 • Number of events 6 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - No reported signs - RA
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - No reported signs - RV
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Unable to Capture - LV
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Unable to capture - RV
|
0.25%
5/2015 • Number of events 5 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Electrode Damaged - RA
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Elevated Threshold - LV
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Elevated Threshold - RA
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV
|
0.25%
5/2015 • Number of events 5 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Extracardiac Stimulation - LV
|
0.30%
6/2015 • Number of events 7 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Helix damaged - RA
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
High Out of Range Impedance - LV
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Impedance Out of Range
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Inappropriate Tachy Therapy - SVT
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Inappropriate tachy therapy - SVT
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Inappropriate tachy therapy - Other
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Other Lead Related
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
PG System diagnosis - OTHER
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
PG System - Patient Related - OTHER
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Unable to Capture - LV
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Unable to Capture - RV
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Unable to Capture - RA
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Psychiatric disorders
Psychological
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Renal and urinary disorders
Genitourinary
|
0.50%
10/2015 • Number of events 12 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Renal and urinary disorders
Renal
|
1.5%
30/2015 • Number of events 36 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Respiratory, thoracic and mediastinal disorders
Adverse Reaction - Respiratory
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.20%
4/2015 • Number of events 5 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion - unrelated procedure/device
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax - unrelated procedure/device
|
0.05%
1/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.7%
35/2015 • Number of events 47 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Skin and subcutaneous tissue disorders
Skin burns
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Cerebrovascular Accident (CVA)
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Cerebrovascular accident (CVA) - ischemic
|
0.30%
6/2015 • Number of events 6 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Chest Pain - Ischemic
|
0.30%
6/2015 • Number of events 6 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Coronary Artery Disease
|
0.79%
16/2015 • Number of events 17 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Deep Vein Thrombosis (DVT)
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Hypotension/Orthostatic Hypotension
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Myocardial Infarction
|
0.45%
9/2015 • Number of events 10 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.55%
11/2015 • Number of events 12 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Pulmonary Embolism (PE)
|
0.25%
5/2015 • Number of events 5 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Transient Ischemic Attack (TIA)
|
0.15%
3/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
Other adverse events
| Measure |
Subjects Implanted De-novo With a BSC CRT-D Together With a Quadripolar Lead From Any Manufacturer.
n=2015 participants at risk
Subjects implanted de-novo with AUTOGEN, INOGEN, DYNAGEN, RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT Boston Scientific (BSC) Cardiac Resynchronization Therapy Defibrillators (CRT-D) had their CRT Response rate evaluated at 12 months, defined by the Milton Packer Clinical Composite Score (CCS). This endpoint combines four metrics: All-cause mortality, Heart failure events, NYHA Class, and Quality of life as measured with the patient global assessment instrument. A subset of 103 subjects implanted with Boston Scientific CRT-D were followed for 36 months to evaluate the PG (pulse generator) related Complication Free rate at 36 months. A SMART Registry subject was considered part of this PMCF (Post Market Clinical Follow Up) when enrolled in a European site, had an RESONATE HF, RESONATE, MOMENTUM, CHARISMA or VIGILANT BSC CRT-D implanted and Left Ventricular MultiSite Pacing (LV MSP) feature was enabled at any time during the initial 12 months follow up. Any reportable adverse events (including deaths) from these 103 subjects, are represented in the mortality and adverse event sections of the results.
|
|---|---|
|
Cardiac disorders
Atrial (Type I) Flutter
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
0.79%
16/2015 • Number of events 18 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Atrial Flutter
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
0.65%
13/2015 • Number of events 16 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Heart Failure Patient Condition - Cardiovascular - OTHER
|
0.10%
2/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Heart Failure Symptoms - Unspecified
|
0.30%
6/2015 • Number of events 9 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Intracardiac thrombus
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Mitral Regurgitation
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Multiple Heart Failure Symptoms
|
0.35%
7/2015 • Number of events 8 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Patient Condition - Cardiovascular - OTHER
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Pericardial Effusion - Heart Failure
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Peripheral edema - Heart Failure
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Premature Ventricular Contractions (PVC)
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Torsades de Pointes
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Ventricular Fibrillation (VF)
|
0.25%
5/2015 • Number of events 7 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
0.84%
17/2015 • Number of events 17 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Chest Pain - Other
|
0.15%
3/2015 • Number of events 3 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Syncope
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
General disorders
Vasovagal Reaction
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Infections and infestations
Infection (> 30 days post implant)
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Infections and infestations
System Infection
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Post Surgical wound discomfort/bruising/swelling
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Post-surgical pocket hemorrhage/bleeding/drainage
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Thromboembolic events
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Injury, poisoning and procedural complications
Venous occlusion
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Conductor Coil Fracture - RA
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - Elevated threshold - RV
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Pregnancy, puerperium and perinatal conditions
Dislodgement - Multiple signs - LV
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Dislodgement - No reported signs - LV
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Elevated Threshold - LV
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Elevated Threshold - RA
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Extracardiac Stimulation - LV
|
0.99%
20/2015 • Number of events 21 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Inappropriate Tachy Therapy - SVT
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Inappropriate tachy therapy - SVT
|
0.20%
4/2015 • Number of events 4 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Inappropriate tachy therapy - NSR
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Inappropriate tachy therapy - Other
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Other - PG System
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Oversensing - RA
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Product Issues
Pacemaker Mediated Tachycardia (PMT)
|
0.25%
5/2015 • Number of events 5 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Renal and urinary disorders
Renal
|
0.05%
1/2015 • Number of events 1 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.05%
1/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
|
Vascular disorders
Hypotension/Orthostatic Hypotension
|
0.10%
2/2015 • Number of events 2 • Up to 36 months
2005 enrolled subjects plus 10 consent ineligible subjects with devices were considered to be at risk of AEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. Sponsor may extend the review period for another 90 days to take steps to protect its intellectual property interests, or to remove any language detrimental to Sponsor's intellectual property interests.
- Publication restrictions are in place
Restriction type: OTHER