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Completed

NCT Number: NCT04675957

Cardiac Rehab Retrospective Review (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.

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Key information

Conditions

Sudden Cardiac Death Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Arrythmia Ventricular Fibrillation Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac rehabilitation

Other

stationary or ambulatory cardiac rehabilitation

Primary outcomes

  1. Number of Arrhythmias (as recorded by clinic or WCD)

    Time frame: 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

  2. Number of adequate WCD alarms (as recorded by WCD) per patient

    Time frame: 3 months

    To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of adequate WCD alarms will be recorded

  3. Number of inadequate WCD alarms (as recorded by WCD) per patient

    Time frame: 3 months

    To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of inadequate WCD alarms will be recorded

  4. Number of patients with appropriate WCD Shocks

    Time frame: 3 months

    To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, the number of appropriate WCD shocks will be collected.

  5. Number of patients with Syncopes/Presyncopes

    Time frame: 3 months

    To investigate the safety and feasibility of WCD therapy during cardiac rehabilitation, data of Syncopes or Pre-Syncopes will be collected.

  6. Number of patients with abnormal blood pressure (measured in mmHg)

    Time frame: 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

  7. Number of other issues with WCD

    Time frame: 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.

  8. Number of other Adverse Events

    Time frame: 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.

  9. Number of patients with inappropriate WCD Shocks

    Time frame: 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 outcomes

  1. Difference in physical exercise capacity - measured in METs

    Time frame: 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.

  2. Performance in ergometry - measured in watts (difference between initial Evaluation and final Evaluation)

    Time frame: 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.

  3. Body weight - measured in kilogram (difference between initial Evaluation and final Evaluation)

    Time frame: 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.

  4. Body Mass Index (BMI, weight and height will be combined to report BMI in kg/m^2); (difference between initial Evaluation and final Evaluation)

    Time frame: 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.

  5. Blood pressure - measured in mmHg (difference between initial Evaluation and final Evaluation)

    Time frame: 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.

  6. Left ventricular ejection fraction - measured in % (difference between initial Evaluation and final Evaluation)

    Time frame: 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.

  7. Left ventricular end diastolic diameter (measured in mm)

    Time frame: 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.

  8. Size of the Left atrial (measured in mm)

    Time frame: 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.

  9. Right atrial diameter (measured in mm)

    Time frame: 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.

  10. diastolic dysfunction (measured in grade)

    Time frame: 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.

  11. Intraventricular septum (diastolic, measured in mm)

    Time frame: 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.

  12. Heart rate derived from the WCD (measured in beats per Minute)

    Time frame: 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.

  13. Body Position derived from the WCD

    Time frame: 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.

  14. Step count derived from the WCD (steps/day)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Zoll Medical Corporation

Registry information

Acronym: CR3

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2020
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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