Cardiac Rehab Retrospective Review (CR3)
Study Details
Study Description
Brief Summary
All patients enrolled in the Austrian LifeVest Registry will be retrospectively screened for successfully completed ambulatory or stationary rehabilitation program. Baseline characteristics, complete rehab data, outcomes and follow up data, as well as wearable cardioverter defibrillator(WCD)-derived data will be collected from these patients.
Specifically, performance data from the start of the exercise training (ET) will be compared to the end of ET; including type of training, exertion, time and duration will be collected. In addition, WCD recorded data such as automatically and manually recorded ECGs, compliance, and TRENDS data will be collected.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Number of Arrhythmias (as recorded by clinic or WCD) [3 months]
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the following data on Arrhythmias captured via WCD or Surface ECG will be collected: Atrial tachycardia Ventricular tachycardia Bradycardia
- Number of adequate WCD alarms (as recorded by WCD) per patient [3 months]
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of adequate WCD alarms will be recorded
- Number of inadequate WCD alarms (as recorded by WCD) per patient [3 months]
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inadequate WCD alarms will be recorded
- Number of patients with appropriate WCD Shocks [3 months]
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of appropriate WCD shocks will be collected.
- Number of patients with Syncopes/Presyncopes [3 months]
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, data of Syncopes or Pre-Syncopes will be collected.
- Number of patients with abnormal blood pressure (measured in mmHg) [3 months]
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the following data for abnormal blood pressure will be collected: Occurrence of Hypotension Occurrence of Hypertension
- Number of other issues with WCD [3 months]
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, every data with an issue with WCD disturbing the normal rehabilitation activities will be collected.
- Number of other Adverse Events [3 months]
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, other adverse events recorded by staff during therapy session that stopped ET session (notWCD specific) will be collected.
- Number of patients with inappropriate WCD Shocks [3 months]
To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inappropriate WCD shocks (captured via LifeVestNetwork) will be collected.
Secondary Outcome Measures
- Difference in physical exercise capacity - measured in METs [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
- Performance in ergometry - measured in watts (difference between initial Evaluation and final Evaluation) [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
- Body weight - measured in kilogram (difference between initial Evaluation and final Evaluation) [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
- Body Mass Index (BMI, weight and height will be combined to report BMI in kg/m^2); (difference between initial Evaluation and final Evaluation) [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
- Blood pressure - measured in mmHg (difference between initial Evaluation and final Evaluation) [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation.
- Left ventricular ejection fraction - measured in % (difference between initial Evaluation and final Evaluation) [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation. With echocardiography the left ventricular ejection fraction (%) will be collected.
- Left ventricular end diastolic diameter (measured in mm) [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation. With Echocardiography Left ventricular end diastolic diameter (mm) will be collected.
- Size of the Left atrial (measured in mm) [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation. With Echocardiography. the size of the Left atrial (mm) will be collected.
- Right atrial diameter (measured in mm) [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation. With Echocardiography, Right atrial diameter (mm) will be collected.
- diastolic dysfunction (measured in grade) [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation. With Echocardiography, the diastolic dysfunction (grade) will be collected.
- Intraventricular septum (diastolic, measured in mm) [3 months]
The measures regarding exercise performance while wearing a WCD during cardiac rehabilitation will be evaluated through the use of descriptive statistics before and after rehabilitation. With Echocardiography, the Intraventricular septum (diastole, mm) will be collected.
- Heart rate derived from the WCD (measured in beats per Minute) [3 months]
The correlation of WCD-derived parameters such as heart rate with patients' exercise performance during cardiac rehabilitation will primarily be an ad-hoc statistical analyses.
- Body Position derived from the WCD [3 months]
The correlation of WCD-derived parameters such as body position with patients' exercise performance during cardiac rehabilitation will primarily be an ad-hoc statistical analyses. Body position is measured by position sensors.
- Step count derived from the WCD (steps/day) [3 months]
The correlation of WCD-derived parameters such as the step count with patients' exercise performance during cardiac rehabilitation will primarily be an ad-hoc statistical analyses.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Prescribed WCD as part of the Austrian WCD registry population from 2014-2018
-
Partial (>50%) or full completion of a rehabilitation program when wearing the WCD in Austria
-
≥18 years old and able to give informed consent
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University | Graz | Austria | 8010 |
Sponsors and Collaborators
- Medical University of Graz
- Zoll Medical Corporation
Investigators
- Principal Investigator: Daniel Scherr, MD, Medical University of Graz
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 90D0204