Clinical trial NCT04675957: Cardiac Rehab Retrospective Review (CR3)
Official title: Cardiac Rehab Retrospective Review (CR3)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Cardiac Death
Heart Failure
Ventricular Arrythmia
Ventricular Tachycardia
Ventricular Fibrillation
Keywords: wearable cardioverter-defibrillator
cardiac rehabilitation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Zoll Medical Corporation
First posted: 2020-12-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Number of Arrhythmias (as recorded by clinic or WCD)
timeFrame: 3 months
measure: Number of adequate WCD alarms (as recorded by WCD) per patient
timeFrame: 3 months
measure: Number of inadequate WCD alarms (as recorded by WCD) per patient
timeFrame: 3 months
measure: Number of patients with appropriate WCD Shocks
timeFrame: 3 months
measure: Number of patients with Syncopes/Presyncopes
timeFrame: 3 months
measure: Number of patients with abnormal blood pressure (measured in mmHg)
timeFrame: 3 months
measure: Number of other issues with WCD
timeFrame: 3 months
measure: Number of other Adverse Events
timeFrame: 3 months
measure: Number of patients with inappropriate WCD Shocks
timeFrame: 3 months
Secondary outcomes:
measure: Difference in physical exercise capacity - measured in METs
timeFrame: 3 months
measure: Performance in ergometry - measured in watts (difference between initial Evaluation and final Evaluation)
timeFrame: 3 months
measure: Body weight - measured in kilogram (difference between initial Evaluation and final Evaluation)
timeFrame: 3 months
measure: Body Mass Index (BMI, weight and height will be combined to report BMI in kg/m^2); (difference between initial Evaluation and final Evaluation)
timeFrame: 3 months
measure: Blood pressure - measured in mmHg (difference between initial Evaluation and final Evaluation)
timeFrame: 3 months
measure: Left ventricular ejection fraction - measured in % (difference between initial Evaluation and final Evaluation)
timeFrame: 3 months
measure: Left ventricular end diastolic diameter (measured in mm)
timeFrame: 3 months
measure: Size of the Left atrial (measured in mm)
timeFrame: 3 months
measure: Right atrial diameter (measured in mm)
timeFrame: 3 months
measure: diastolic dysfunction (measured in grade)
timeFrame: 3 months
measure: Intraventricular septum (diastolic, measured in mm)
timeFrame: 3 months
measure: Heart rate derived from the WCD (measured in beats per Minute)
timeFrame: 3 months
measure: Body Position derived from the WCD
timeFrame: 3 months
measure: Step count derived from the WCD (steps/day)
timeFrame: 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University
Study officials:
affiliation: Medical University of Graz
name: Daniel Scherr, MD
role: PRINCIPAL_INVESTIGATOR
References: