RecruitingNot ApplicableNCT04027777

Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

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

Sponsor

Aktiia SA

Enrollment

355 participants

Start Date

Aug 6, 2019

Study Type

INTERVENTIONAL

Conditions

Blood Pressure

Summary

Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks

Eligibility

Min Age: 21 YearsMax Age: 85 Years

Inclusion Criteria13

ARM1
Adult subjects (aged between 21 and 65 years old)
Subjects fluent in written and spoken French
Subjects agreeing to attend the totality of 4 visits
Subjects that have signed the informed consent form
Adult subjects (aged between 21 and 65 years old)
Subjects fluent in written and spoken French
Subjects agreeing to attend the totality of 4 visits
Subjects that have signed the informed consent form
Adult subjects (aged between 65 and 85 years old)
Subjects fluent in written and spoken French
Subjects agreeing to attend the totality of 4 visits
Subjects that have signed the informed consent form

Exclusion Criteria170

Subjects with tachycardia (heart rate at rest > 120bpm)
Subjects with atrial fibrillation
Subjects with diabetes
Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
Subjects with hyper-/hypothyroidism
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 (limitation due Aktiia.bracelet-P0 size)
Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
Subjects with lymphoedema (limitation due to participant discomfort)
ARM2
Subjects with tachycardia (heart rate at rest > 120bpm)
Subjects with atrial fibrillation
Subjects with hyper-/hypothyroidism
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 (limitation due Aktiia.bracelet-P0 size)
Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
Subjects with lymphoedema (limitation due to participant discomfort)
ARM3
Subjects with tachycardia (heart rate at rest > 120bpm)
Subjects with atrial fibrillation
Subjects with diabetes
Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
Subjects with hyper-/hypothyroidism
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 (limitation due Aktiia.bracelet-P0 size)
Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
Subjects with lymphoedema (limitation due to participant discomfort)
ARM 4
The study arm will include:
Adult subjects aged between 21 and 85 years old
Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
Subjects fluent in written and spoken French
Subjects agreeing to attend the totality of 4 visits
Subjects residing within 100 km of the CHUV site
Subjects able to pedal with an ergocycle
Subjects that have signed the informed consent form
The study will exclude:
Subjects undergoing dialysis treatment
Subjects with tachycardia (heart rate at rest > 120bpm)
Subjects with atrial fibrillation
Subjects with diabetes
Subjects with untreated hyper-/hypothyroidism
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 > 23 cm
Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
Subjects with the exfoliative skin diseases
Subjects with lymphoedema
ARM 5
The study arm will include:
Adult subjects aged between 21 and 85 years old
Subjects with chronic systolic heart failure (Heart Failure with reduce Ejection Fraction), defined by a left ventricular ejection fraction (LVEF) of less than or equal to 40%, confirmed by Echocardiography or MRI
Subjects fluent in written and spoken French
Subjects agreeing to attend the totality of 4 visits
Subjects residing within 100 km of the CHUV site
Subjects able to pedal with an ergocycle
Subjects that have signed the informed consent form
The study will exclude:
Subjects with tachycardia (heart rate at rest > 120bpm)
Subjects with atrial fibrillation
Subjects with diabetes
Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
Subjects with untreated hyper-/hypothyroidism
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 > 23 cm
Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
Subjects with the exfoliative skin diseases
Subjects with lymphoedema
ARM 6
The study arm will include:
Subjects who are adult females aged 21 years or older
Subjects who are pregnant beyond the first trimester, with a gestational age of more than 12 weeks, confirmed by documentation from a gynecologist
Subjects not requiring hospitalization
Subjects fluent in written and spoken French
Subjects agreeing to attend the totality of 4 visits
Subjects residing within 100 km of the CHUV site.
Subjects that have signed the informed consent form
The study will exclude:
Subjects with tachycardia (heart rate at rest > 120bpm
Subjects with atrial fibrillation
Subjects with diabetes
Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
Subjects with untreated hyper/hypotyroidism not related to pregnancy changes
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
Subjects with an arteriovenous fistula
Subjects with arm amputations
Subjects with the upper arm circumference > 64 cm
Subjects with the wrist circumference > 23 cm
Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
Subjects with the exfoliative skin diseases
Subjects with lymphoedema
ARM 7
The study arm will include:
Subjects who are adult females aged 21 years or older
Subjects who are postpartum, defined as having given birth within the last 6 weeks and not currently pregnant
Subjects fluent in written and spoken French
Subjects agreeing to attend the totality of 4 visits
Subjects residing within 100 km of the CHUV site.
Subjects that have signed the informed consent form
The study will exclude:
Subjects with tachycardia (heart rate at rest > 120bpm)
Subjects with atrial fibrillation
Subjects with diabetes
Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
Subjects with untreated hyper-/hypothyroidism
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 > 23 cm
Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
Subjects with the exfoliative skin diseases
Subjects with lymphoedema.

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Interventions

DEVICEAktiia.product-P0

The optical signals at the wrist are recorded non-invasively by means of the Aktiia.product-P0 investigational device. The BP measurements are further determined from these optical signals and are compared to the reference double auscultation BP readings. A reference-control volume clamp BP reading is recorded simultaneously.