Cardiac Rehab Retrospective Review (CR3) (CR3)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Arrythmia; Sudden Cardiac Death
• Intervention / Treatment: Other: cardiac rehabilitation

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All Austrian patients with a WCD having the TRENDS feature who underwent cardiac rehabilitation from 2014-18 will be retrospectively analyzed.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Collaborators: Zoll Medical Corporation
• Investigators: Principal Investigator: Daniel Scherr, MD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): April 12, 2022
• Study Completion (Actual): April 12, 2022

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: cardiac rehabilitation; wearable cardioverter-defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Arrest; Death; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Death, Sudden, Cardiac
• Other Study ID Numbers: 90D0204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No