Cardiac Rehab Retrospective Review (CR3)

Heart Failure Clinical Trial

— CR3  

Official title:

Cardiac Rehab Retrospective Review (CR3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04675957
• Other study ID #: 90D0204
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: April 12, 2022

Study information

• Verified date: April 2022
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrythmia
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Other:
• cardiac rehabilitation
stationary or ambulatory cardiac rehabilitation

Locations

Country	Name	City	State
Austria	Medical University	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Zoll Medical Corporation

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Arrhythmias (as recorded by clinic or WCD)	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	3 months
Primary	Number of adequate WCD alarms (as recorded by WCD) per patient	To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of adequate WCD alarms will be recorded	3 months
Primary	Number of inadequate WCD alarms (as recorded by WCD) per patient	To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inadequate WCD alarms will be recorded	3 months
Primary	Number of patients with appropriate WCD Shocks	To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of appropriate WCD shocks will be collected.	3 months
Primary	Number of patients with Syncopes/Presyncopes	To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, data of Syncopes or Pre-Syncopes will be collected.	3 months
Primary	Number of patients with abnormal blood pressure (measured in mmHg)	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	3 months
Primary	Number of other issues with WCD	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.	3 months
Primary	Number of other Adverse Events	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.	3 months
Primary	Number of patients with inappropriate WCD Shocks	To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inappropriate WCD shocks (captured via LifeVestNetwork) will be collected.	3 months
Secondary	Difference in physical exercise capacity - measured in METs	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.	3 months
Secondary	Performance in ergometry - measured in watts (difference between initial Evaluation and final Evaluation)	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.	3 months
Secondary	Body weight - measured in kilogram (difference between initial Evaluation and final Evaluation)	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.	3 months
Secondary	Body Mass Index (BMI, weight and height will be combined to report BMI in kg/m^2); (difference between initial Evaluation and final Evaluation)	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.	3 months
Secondary	Blood pressure - measured in mmHg (difference between initial Evaluation and final Evaluation)	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.	3 months
Secondary	Left ventricular ejection fraction - measured in % (difference between initial Evaluation and final Evaluation)	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.	3 months
Secondary	Left ventricular end diastolic diameter (measured in mm)	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.	3 months
Secondary	Size of the Left atrial (measured in mm)	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.	3 months
Secondary	Right atrial diameter (measured in mm)	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.	3 months
Secondary	diastolic dysfunction (measured in grade)	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.	3 months
Secondary	Intraventricular septum (diastolic, measured in mm)	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.	3 months
Secondary	Heart rate derived from the WCD (measured in beats per Minute)	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.	3 months
Secondary	Body Position derived from the WCD	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.	3 months
Secondary	Step count derived from the WCD (steps/day)	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.	3 months