Trial Outcomes & Findings for Brady MX a Quality Improvement Study (NCT NCT02976181)
NCT ID: NCT02976181
Last Updated: 2019-09-19
Results Overview
Because the study intervention was not conducted, it is not possible to compare the proportion of subjects with an SND diagnosis pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of subjects with an SND diagnosis in Phase I are reported
Recruitment status
COMPLETED
Target enrollment
113 participants
Primary outcome timeframe
6 and 12 months
Results posted on
2019-09-19
Participant Flow
Participant milestones
| Measure |
Single Arm/Group Observational Registry
Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy
|
|---|---|
|
Overall Study
STARTED
|
113
|
|
Overall Study
COMPLETED
|
112
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brady MX a Quality Improvement Study
Baseline characteristics by cohort
| Measure |
Single Arm/Group Observational Registry
n=112 Participants
Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy
|
|---|---|
|
Age, Continuous
Mean St. Dev.
|
63.6 years
STANDARD_DEVIATION 17.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
112 Participants
n=99 Participants
|
|
Region of Enrollment
Mexico
|
112 Participants
n=99 Participants
|
|
Body Mass Index (BMI)
|
27.6 kg/m2
STANDARD_DEVIATION 4.9 • n=99 Participants
|
|
Blood Pressure
Systolic Blood Pressure
|
125.8 mmHg
STANDARD_DEVIATION 20.7 • n=99 Participants
|
|
Blood Pressure
Diastolic Blood Pressure
|
74.9 mmHg
STANDARD_DEVIATION 10.5 • n=99 Participants
|
|
Height
|
161.6 cm
STANDARD_DEVIATION 9.1 • n=99 Participants
|
|
Weight
|
72.0 kg
STANDARD_DEVIATION 13.8 • n=99 Participants
|
|
Symptoms
None
|
6 Participants
n=99 Participants
|
|
Symptoms
Chest pain
|
17 Participants
n=99 Participants
|
|
Symptoms
Dizziness / lightheadedness / presyncope
|
63 Participants
n=99 Participants
|
|
Symptoms
Dyspnea / shortness of breath
|
30 Participants
n=99 Participants
|
|
Symptoms
Edema
|
4 Participants
n=99 Participants
|
|
Symptoms
Exercise intolerance
|
30 Participants
n=99 Participants
|
|
Symptoms
Fatigue / weakness / lethargy
|
35 Participants
n=99 Participants
|
|
Symptoms
Malaise
|
11 Participants
n=99 Participants
|
|
Symptoms
Palpitations
|
24 Participants
n=99 Participants
|
|
Symptoms
Syncope
|
25 Participants
n=99 Participants
|
|
Cardiac and Vascular History
None
|
40 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Brugada syndrome
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Cardiac arrest
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Cardiomyopathy
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Congenital heart disease
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Congestive heart failure
|
2 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Coronary artery disease
|
8 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Familial or inherited conditions with high risk fo
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Hypertension
|
55 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Hypotension
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Left ventricular hypertrophy
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Long Q/T Syndrome
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Myocardial infarction
|
6 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Primary / idiopathic electrical disease
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Pulmonary hypertension (PH)
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Valve dysfunction
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Other cardiovascular history
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Subject does not have heart failure
|
29 Participants
n=99 Participants
|
|
Cardiac and Vascular History
NYHA Class I
|
53 Participants
n=99 Participants
|
|
Cardiac and Vascular History
NYHA Class II
|
12 Participants
n=99 Participants
|
|
Cardiac and Vascular History
NYHA Class III
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
NYHA Class IV
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
No Cardiovascular Surgical History
|
109 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Ablation
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Carotid endarterectomy
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Carotid stent
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Coronary artery bypass graft (CABG)
|
2 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Coronary artery intervention
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Renal stent
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Surgical MAZE
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Valve repair
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Valve replacement
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
No Atrial Arrythmias
|
88 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Atrial asystole
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
AV nodal re-entrant tachycardia
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Premature atrial complexes
|
2 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Premature atrial complexes, non-conducted
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
SA nodal re-entry
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Sinus node dysfunction
|
20 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Atrial fibrillation, paroxysmal
|
5 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Atrial fibrillation, persistant
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Atrial fibrillation, permanent
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Atrial flutter
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Atrial tachycardia
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Wandering atrial pacemaker
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
No Ventricular Arrhythmias
|
107 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Idioventricular (ventricular escape)
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Premature ventricular complexes (extrasystole)
|
4 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Torsades de pointes
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Ventricular asystole
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Ventricular fibrillation
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Ventricular flutter
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Ventricular tachycardia
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
No AV Junctional Arrhythmias and Blocks
|
104 Participants
n=99 Participants
|
|
Cardiac and Vascular History
1st degree AV block
|
3 Participants
n=99 Participants
|
|
Cardiac and Vascular History
2nd degree AV block, type 1 (Wenckebach)
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Other AV junctional arrhythmias and blocks
|
4 Participants
n=99 Participants
|
|
Cardiac and Vascular History
No Vascular History
|
104 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Carotid artery disease
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Cerebrovascular accident (stroke)
|
3 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Deep vein thrombosis
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Transient ischemic attack
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Peripheral edema
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Peripheral vascular disease
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Poor peripheral perfusion
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Pulmonary edema
|
1 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Pulmonary embolism
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Raynaud's phenomenon
|
0 Participants
n=99 Participants
|
|
Cardiac and Vascular History
Vascular aneurysm
|
1 Participants
n=99 Participants
|
|
Endocrine History
None
|
84 Participants
n=99 Participants
|
|
Endocrine History
Diabetes mellitus
|
15 Participants
n=99 Participants
|
|
Endocrine History
Hormone replacement therapy
|
0 Participants
n=99 Participants
|
|
Endocrine History
Hyperlipidemia
|
4 Participants
n=99 Participants
|
|
Endocrine History
Hyperthyroidism
|
2 Participants
n=99 Participants
|
|
Endocrine History
Hypothyroidism
|
6 Participants
n=99 Participants
|
|
Endocrine History
Renal dysfunction, requiring dialysis
|
1 Participants
n=99 Participants
|
|
Endocrine History
Renal dysfunction, not requiring dialysis
|
6 Participants
n=99 Participants
|
|
Endocrine History
Renal dysfunction, unknown dialysis
|
0 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
None
|
105 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Asthma
|
1 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Chronic obstructive pulmonary disease (COPD)
|
3 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Emphysema
|
0 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Hemoptysis
|
0 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Lung cancer
|
0 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Persistent cough
|
1 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Pleural effusion
|
0 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Pneumonia
|
1 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Pulmonary fibrosis
|
0 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Respiratory failure
|
0 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Sleep apnea
|
1 Participants
n=99 Participants
|
|
Respiratory / Pulmonary History
Tuberculosis
|
0 Participants
n=99 Participants
|
|
Smoking Status
Subject never smoked (habitually)
|
60 Participants
n=99 Participants
|
|
Smoking Status
Subject currently smokes (habitually)
|
13 Participants
n=99 Participants
|
|
Smoking Status
Subject has previously smoked (habitually) but doe
|
38 Participants
n=99 Participants
|
|
Smoking Status
Unknown
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 and 12 monthsPopulation: Number of SND Diagnoses by Time to Diagnosis
Because the study intervention was not conducted, it is not possible to compare the proportion of subjects with an SND diagnosis pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of subjects with an SND diagnosis in Phase I are reported
Outcome measures
| Measure |
Single Arm/Group Observational Registry
n=111 Participants
Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy
|
|---|---|
|
Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.
6 Months
|
69 Participants
|
|
Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.
12 Months
|
70 Participants
|
SECONDARY outcome
Timeframe: 3, 6, and 15 monthsPopulation: Because the study intervention was not conducted, it is not possible to compare the proportion of subjects receiving indicated therapy pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of SND subjects receiving indicated IPG therapy in Phase I are reported
The change between subjects referred to an indicated IPG will be measured after the intervention in total number of patients that are referred correctly. Because the study intervention was not conducted, it is not possible to compare the proportion of subjects receiving therapy referral for an indicated IPG pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of SND subjects receiving a referral for an indicated IPG device in Phase I are reported.
Outcome measures
| Measure |
Single Arm/Group Observational Registry
n=70 Participants
Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy
|
|---|---|
|
Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention
3 Months
|
17 Participants
|
|
Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention
6 Months
|
18 Participants
|
|
Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention
15 Months
|
19 Participants
|
|
Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention
Not implanted
|
51 Participants
|
Adverse Events
Single Arm/Group Observational Registry
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place