Sinus Node Disfunction
Conditions
Brief summary
Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that lack of awareness of treatment and diagnostics pathways result in lower number of referrals to implanters of IPG.
Interventions
DEVICEIPG
Patient might require IPG device to be implanted under standard of care
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patient at least 18 years of age * Patient´s heart rate meets at least one of the following: Patient has a sinus rate ≤ 50 OR a junctional escape rhythm no faster than 50 Patient has a history of exercise intolerance * Patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea OR malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia) * Patient (or patient´s legally authorized representative) is willing and able to sign and date written Patient Consent Form/Data Release Form
Exclusion criteria
* Patient has recent history of blood loss * Patient has a medical history leading to suspicion of neurological disorder * Patient has a history of Chronic Atrial Fibrilation * Patient is enrolled or planing to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from Medtronic study manager * Patient is not expected to survive 12 months * Patient is anticipated to be unwilling or unable to comply with the clinical investigation plan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time. | 6 and 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention | 3, 6, and 15 months | 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. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm/Group Observational Registry Bradycardia patients with both signs and symptoms of bradycardia, prior to diagnosis of SND and IPG therapy | 112 |
| Total | 112 |
Baseline characteristics
| Characteristic | Single Arm/Group Observational Registry |
|---|---|
| Age, Continuous Mean St. Dev. | 63.6 years STANDARD_DEVIATION 17.1 |
| Blood Pressure Diastolic Blood Pressure | 74.9 mmHg STANDARD_DEVIATION 10.5 |
| Blood Pressure Systolic Blood Pressure | 125.8 mmHg STANDARD_DEVIATION 20.7 |
| Body Mass Index (BMI) | 27.6 kg/m2 STANDARD_DEVIATION 4.9 |
| Cardiac and Vascular History 1st degree AV block | 3 Participants |
| Cardiac and Vascular History 2nd degree AV block, type 1 (Wenckebach) | 0 Participants |
| Cardiac and Vascular History Ablation | 0 Participants |
| Cardiac and Vascular History Atrial asystole | 0 Participants |
| Cardiac and Vascular History Atrial fibrillation, paroxysmal | 5 Participants |
| Cardiac and Vascular History Atrial fibrillation, permanent | 0 Participants |
| Cardiac and Vascular History Atrial fibrillation, persistant | 0 Participants |
| Cardiac and Vascular History Atrial flutter | 0 Participants |
| Cardiac and Vascular History Atrial tachycardia | 0 Participants |
| Cardiac and Vascular History AV nodal re-entrant tachycardia | 0 Participants |
| Cardiac and Vascular History Brugada syndrome | 0 Participants |
| Cardiac and Vascular History Cardiac arrest | 0 Participants |
| Cardiac and Vascular History Cardiomyopathy | 1 Participants |
| Cardiac and Vascular History Carotid artery disease | 0 Participants |
| Cardiac and Vascular History Carotid endarterectomy | 0 Participants |
| Cardiac and Vascular History Carotid stent | 0 Participants |
| Cardiac and Vascular History Cerebrovascular accident (stroke) | 3 Participants |
| Cardiac and Vascular History Congenital heart disease | 0 Participants |
| Cardiac and Vascular History Congestive heart failure | 2 Participants |
| Cardiac and Vascular History Coronary artery bypass graft (CABG) | 2 Participants |
| Cardiac and Vascular History Coronary artery disease | 8 Participants |
| Cardiac and Vascular History Coronary artery intervention | 1 Participants |
| Cardiac and Vascular History Deep vein thrombosis | 0 Participants |
| Cardiac and Vascular History Familial or inherited conditions with high risk fo | 0 Participants |
| Cardiac and Vascular History Hypertension | 55 Participants |
| Cardiac and Vascular History Hypotension | 1 Participants |
| Cardiac and Vascular History Idioventricular (ventricular escape) | 0 Participants |
| Cardiac and Vascular History Left ventricular hypertrophy | 0 Participants |
| Cardiac and Vascular History Long Q/T Syndrome | 0 Participants |
| Cardiac and Vascular History Myocardial infarction | 6 Participants |
| Cardiac and Vascular History No Atrial Arrythmias | 88 Participants |
| Cardiac and Vascular History No AV Junctional Arrhythmias and Blocks | 104 Participants |
| Cardiac and Vascular History No Cardiovascular Surgical History | 109 Participants |
| Cardiac and Vascular History None | 40 Participants |
| Cardiac and Vascular History No Vascular History | 104 Participants |
| Cardiac and Vascular History No Ventricular Arrhythmias | 107 Participants |
| Cardiac and Vascular History NYHA Class I | 53 Participants |
| Cardiac and Vascular History NYHA Class II | 12 Participants |
| Cardiac and Vascular History NYHA Class III | 1 Participants |
| Cardiac and Vascular History NYHA Class IV | 0 Participants |
| Cardiac and Vascular History Other AV junctional arrhythmias and blocks | 4 Participants |
| Cardiac and Vascular History Other cardiovascular history | 1 Participants |
| Cardiac and Vascular History Peripheral edema | 1 Participants |
| Cardiac and Vascular History Peripheral vascular disease | 1 Participants |
| Cardiac and Vascular History Poor peripheral perfusion | 0 Participants |
| Cardiac and Vascular History Premature atrial complexes | 2 Participants |
| Cardiac and Vascular History Premature atrial complexes, non-conducted | 0 Participants |
| Cardiac and Vascular History Premature ventricular complexes (extrasystole) | 4 Participants |
| Cardiac and Vascular History Primary / idiopathic electrical disease | 1 Participants |
| Cardiac and Vascular History Pulmonary edema | 1 Participants |
| Cardiac and Vascular History Pulmonary embolism | 0 Participants |
| Cardiac and Vascular History Pulmonary hypertension (PH) | 0 Participants |
| Cardiac and Vascular History Raynaud's phenomenon | 0 Participants |
| Cardiac and Vascular History Renal stent | 0 Participants |
| Cardiac and Vascular History SA nodal re-entry | 0 Participants |
| Cardiac and Vascular History Sinus node dysfunction | 20 Participants |
| Cardiac and Vascular History Subject does not have heart failure | 29 Participants |
| Cardiac and Vascular History Surgical MAZE | 0 Participants |
| Cardiac and Vascular History Torsades de pointes | 0 Participants |
| Cardiac and Vascular History Transient ischemic attack | 0 Participants |
| Cardiac and Vascular History Valve dysfunction | 1 Participants |
| Cardiac and Vascular History Valve repair | 0 Participants |
| Cardiac and Vascular History Valve replacement | 0 Participants |
| Cardiac and Vascular History Vascular aneurysm | 1 Participants |
| Cardiac and Vascular History Ventricular asystole | 0 Participants |
| Cardiac and Vascular History Ventricular fibrillation | 0 Participants |
| Cardiac and Vascular History Ventricular flutter | 0 Participants |
| Cardiac and Vascular History Ventricular tachycardia | 1 Participants |
| Cardiac and Vascular History Wandering atrial pacemaker | 0 Participants |
| Endocrine History Diabetes mellitus | 15 Participants |
| Endocrine History Hormone replacement therapy | 0 Participants |
| Endocrine History Hyperlipidemia | 4 Participants |
| Endocrine History Hyperthyroidism | 2 Participants |
| Endocrine History Hypothyroidism | 6 Participants |
| Endocrine History None | 84 Participants |
| Endocrine History Renal dysfunction, not requiring dialysis | 6 Participants |
| Endocrine History Renal dysfunction, requiring dialysis | 1 Participants |
| Endocrine History Renal dysfunction, unknown dialysis | 0 Participants |
| Height | 161.6 cm STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 112 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Mexico | 112 Participants |
| Respiratory / Pulmonary History Asthma | 1 Participants |
| Respiratory / Pulmonary History Chronic obstructive pulmonary disease (COPD) | 3 Participants |
| Respiratory / Pulmonary History Emphysema | 0 Participants |
| Respiratory / Pulmonary History Hemoptysis | 0 Participants |
| Respiratory / Pulmonary History Lung cancer | 0 Participants |
| Respiratory / Pulmonary History None | 105 Participants |
| Respiratory / Pulmonary History Persistent cough | 1 Participants |
| Respiratory / Pulmonary History Pleural effusion | 0 Participants |
| Respiratory / Pulmonary History Pneumonia | 1 Participants |
| Respiratory / Pulmonary History Pulmonary fibrosis | 0 Participants |
| Respiratory / Pulmonary History Respiratory failure | 0 Participants |
| Respiratory / Pulmonary History Sleep apnea | 1 Participants |
| Respiratory / Pulmonary History Tuberculosis | 0 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 61 Participants |
| Smoking Status Subject currently smokes (habitually) | 13 Participants |
| Smoking Status Subject has previously smoked (habitually) but doe | 38 Participants |
| Smoking Status Subject never smoked (habitually) | 60 Participants |
| Smoking Status Unknown | 1 Participants |
| Symptoms Chest pain | 17 Participants |
| Symptoms Dizziness / lightheadedness / presyncope | 63 Participants |
| Symptoms Dyspnea / shortness of breath | 30 Participants |
| Symptoms Edema | 4 Participants |
| Symptoms Exercise intolerance | 30 Participants |
| Symptoms Fatigue / weakness / lethargy | 35 Participants |
| Symptoms Malaise | 11 Participants |
| Symptoms None | 6 Participants |
| Symptoms Palpitations | 24 Participants |
| Symptoms Syncope | 25 Participants |
| Weight | 72.0 kg STANDARD_DEVIATION 13.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.
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
Time frame: 6 and 12 months
Population: Number of SND Diagnoses by Time to Diagnosis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm/Group Observational Registry | Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time. | 6 Months | 69 Participants |
| Single Arm/Group Observational Registry | Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time. | 12 Months | 70 Participants |
Secondary
Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention
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.
Time frame: 3, 6, and 15 months
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm/Group Observational Registry | Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention | 3 Months | 17 Participants |
| Single Arm/Group Observational Registry | Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention | 6 Months | 18 Participants |
| Single Arm/Group Observational Registry | Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention | 15 Months | 19 Participants |
| Single Arm/Group Observational Registry | Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention | Not implanted | 51 Participants |