New heart device shows promise for angina sufferers
NCT ID NCT06571370
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new device called the Wave PRO System that helps improve blood flow in people with chronic stable angina (chest pain). The device works by gently squeezing the legs to push more blood to the heart. The study included 52 adults with mild to moderate coronary artery disease. The goal was to see if the new device works as well as an existing device already on the market.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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52 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Feb 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 35 years or greater * History of mild to moderate coronary artery disease (CAD) * Able to ambulate without assistance * Able to lay down (approximately 5 degree angle) for the duration of study procedures * Able and willing to give informed consent * Able and willing to attend the ECP session and complete all questionnaires provided Exclusion Criteria: * Unstable angina within prior 3 months * Canadian Cardiovascular Society (CCS) Class III or IV Angina * Moderate to severe peripheral arterial disease (PAD) * Myocardial infarction in the past 3 months * Coronary artery bypass grafting (CABG) in the past 3 months * Any major surgery within the past 3 months * Decompensated heart failure * Cardiac catheterization or arterial femoral puncture in the past 2 weeks * Presence of mechanical circulatory support (MCS) device * Pacemaker or other implantable pulse generating device * Valve disease, including aortic insufficiency * Abdominal or thoracic aortic dissection or aortic/cerebral aneurysms requiring clinical intervention * Severe pulmonary disease * Bleeding diathesis * Active thrombophlebitis * Uncontrolled hypertension (greater than 180/110 mmHg) * Baseline heart rate greater than 120 beats per minute or below 40 beats per minute * Arrhythmia and/or abnormal heart rhythm * Major hand injuries or amputation that would interfere with fingertip PPG * Unhealed wounds/fractures below the waist or lower limb amputation , general lower body musculoskeletal injuries * Vascular stents (arterial/venous) or orthopedic implants in the lower limbs * Currently undergoing ECP treatment * Pregnancy * Currently participating in any other clinical study of an investigational device or drug where treatment has not yet been completed * Participants with coagulopathy (PT-INR\>2.5) or taking blood thinners (e.g., warfarin) * Any medical condition that, in the opinion of the principal investigator (PI), would present undue risk to the participant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
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Other studies related to the condition(s) this trial covers.
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