## Protocol Section
### Identification Module
**NCT ID:** NCT06422468

**Acronym:** CARDS-pilot

**Brief Title:** Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring

**Official Title:** Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring: a Pilot Study

#### Organization Study ID Info
**ID:** Z-2023103
#### Organization
**Class:** INDUSTRY
**Full Name:** Qompium NV
### Status Module
#### Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-08
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Qompium NV

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this interventional clinical trial is to investigate whether combining photoplethysmography (PPG) signals with accelerometer (ACC), gyroscope (GYR), sound, and electrocardiography (ECG) derived smartphone data provides additional insights into the cardiac condition of individuals with and without atrial fibrillation (AF).

### Conditions Module

**Conditions:**

- Atrial Fibrillation

**Keywords:**

- Photoplethysmography

- Single-lead Electrocardiography

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 125

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: FibriCheck recordings

**Label:** FibriCheck recordings

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- FibriCheck recordings

**Description:** PPG, ACC, GYR, ECG and sound measurements

**Name:** FibriCheck recordings

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Detect or identify specific morphologic characteristics (changes or correlations) by the comparison of PPG signals, accelerometer signals, gyroscope signals, sound signals and ECG signals, derived via the smartphone data.

**Measure:** Identification of morphologic characteristics of smartphone generated signals

**Time Frame:** 1 day

#### Secondary Outcomes

**Description:** Evaluate the performance of our PPG FibriCheck Algorithm in cardiology patients and healthy volunteers, based on simultaneously recorded ECG data (RR intervals).

**Measure:** Evaluate the performance of the FibriCheck Algorithm

**Time Frame:** 1 day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Inclusion criteria applicable for all groups:

* At least 18 years old
* Participants must have the ability to understand and provide written informed consent
* Participants must have the ability to understand Dutch

Group specific inclusion criteria:

Group 1: Healthy volunteers

* No cardiac conditions based on medical history.

Group 2: Cardiology patients

* Patients at the consultation or ambulatory unit of Cardiology (pre- cardioversion, pre-pulmonary vein isolation) with AF.
* Patients without AF but with a current cardiac condition (e.g. heart failure with a reduced or preserved ejection fraction) or a history of a cardiac condition (e.g. history of myocardial infarction).

Exclusion Criteria:

* Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device
* Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement
* Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow
* Persons that have a disability to perform the measurements according to the instructions for use
* Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Lars.Grieten@fibricheck.com

**Name:** Lars Grieten, PhD

**Phone:** +3211485953

**Role:** CONTACT

**Contact 2:**

**Email:** Annelies.Geeraerts@fibricheck.com

**Name:** Annelies Geeraerts, PhD

**Phone:** +3211485953

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Genk

**Contacts:**

***Contact 1:***

- **Email:** pieter.vandervoort@zol.be

- **Name:** Pieter Vandervoort, MD

- **Phone:** 089/325050

- **Role:** CONTACT

**Country:** Belgium

**Facility:** Ziekenhuis Oost Limburg

**State:** Limburg

**Status:** RECRUITING

**Zip:** 3600

#### Overall Officials

**Official 1:**

**Affiliation:** Ziekenhuis Oost-Limburg

**Name:** Pieter Vandervoort, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001281

- Term: Atrial Fibrillation

### Misc Info Module

- Version Holder: 2024-05-31
