Cardiac Rehab Retrospective Review (CR3)

NCT04675957 | Completed

• 1 other identifier: 90D0204
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Cardiac Death; Heart Failure; Ventricular Arrythmia; Ventricular Tachycardia; Ventricular Fibrillation

Keywords

wearable cardioverter-defibrillator; cardiac rehabilitation

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (14)

• Difference in physical exercise capacity - measured in METs

  3 months

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

  3 months

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

  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)

  3 months

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

  3 months

Interventions

cardiac rehabilitation OTHER

stationary or ambulatory cardiac rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- none

Sponsors & Collaborators

• Medical University of Graz: lead
• Zoll Medical Corporation: collaborator

Study Sites (1)

Medical University

Graz, 8010, Austria

Location

Related Publications (1)

• Rohrer U, Reischl A, Manninger M, Binder RK, Fiedler L, Gruska M, Altenberger J, Dorr A, Steinwender C, Stuehlinger M, Wonisch M, Zirngast B, Zweiker D, Zirlik A, Scherr D; Austrian WCD Study Group. Cardiovascular Rehabilitation With a WCD-Data From the CR3 Study (Cardiac Rehab Retrospective Review). J Cardiopulm Rehabil Prev. 2024 Mar 1;44(2):115-120. doi: 10.1097/HCR.0000000000000832. Epub 2023 Nov 30.

  PMID: 38032261 DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac; Heart Failure; Tachycardia, Ventricular; Ventricular Fibrillation

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Daniel Scherr, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: December 19, 2020
• Study Start: February 1, 2021
• Primary Completion: April 12, 2022
• Study Completion: April 12, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)