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) (OBPM_ABPM2020)

Cyril Pellaton

Status: Completed

Conditions: Hypertension; Blood Pressure

Treatments: Device: Aktiia.product

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04548986

OBPM_ABPM2020

Details and patient eligibility

About

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

Enrollment: 63 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

single arm

Other group

Description:

single arm study

Treatment:

Device: Aktiia.product