Single-center Prospective Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Ambulatory Blood Pressure Monitoring (ABPM)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-06

Study Completion Date

2022-12-23

Brief Summary

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This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.

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Detailed Description

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Conditions

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Blood Pressure Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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single arm

single arm study

Group Type OTHER

Aktiia.product

Intervention Type DEVICE

The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.

Interventions

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Aktiia.product

The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult subjects (aged between 21 and 65)
* Subjects fluent in written and spoken French
* Subjects enrolled in a 12-weeks cardiac rehabilitation program
* Subjects agreeing to participate
* Subjects that have signed the informed consent form

Exclusion Criteria

* Subjects with tachycardia (heart rate at rest \> 120bpm)
* Subjects with atrial fibrillation
* Subjects with severe heart failure (LVEF\<35%)
* Subjects with severe renal dysfunctions (eGFR \< 30mL/min/1.73 m2)
* Subjects with pheochromocytoma
* Subjects with Raynaud's disease
* Subjects with trembling and shivering
* Subjects with interarm systolic difference \> 15 mmHg
* Subjects with interarm diastolic difference \> 10 mmHg
* Subjects with arm paralysis
* Women in known pregnancy
* Subjects with an arteriovenous fistula
* Subjects with arm amputations
* Subjects with the upper arm circumference \> 64 cm
* Subjects with the wrist circumference \> 22 cm
* Subjects with the exfoliative skin diseases
* Subjects with lymphoedema

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No