Transcatheter Aortic Valve Replacement (TAVR)FRESH-TNCT07365345
Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients
A study testing electrical acupoint stimulation in people with Transcatheter Aortic Valve Replacement (TAVR) and Hemodynamic Stability, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan, Jian Shi, and Baihui. The changes in blood pressure during the anesthesia induction period were compared between the high-frequency group and the low-frequency group. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability, Anesthesia Induction
- What is being tested?
- electrical acupoint stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age of the patients is 60 years or older;
- Patients who are scheduled to undergo TAVR surgery under general anesthesia;
Who cannot join
- Body mass index less than 18 kg/m2 or greater than 30 kg/m2;
- Hemodynamic instability (severe arrhythmia, decompensated heart failure);
- Hypotension after admission requiring intervention with vasoactive drugs;
- Severe liver or kidney dysfunction;
- Those who are contraindicated for electrical stimulation, including those with local skin damage, infection, or having implanted electrophysiological devices in the body.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital, Fourth Military Medical University
Xi'an, Shannxi, 710032
Zhihong Lu, Doctor, 86-29-84775343, deerlu23@163.com
About this study
Official title: The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction in Patients Undergoing TAVR Surgery
Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan, Jian Shi, and Baihui. The changes in blood pressure during the anesthesia induction period were compared between the high-frequency group and the low-frequency group.
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability, Anesthesia Induction, Electro-acupuncture
- Being tested
- electrical acupoint stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical acupoint stimulationOther
Electrical stimulation are administered at Neiguan, Jian Shi, and Baihui. The stimulation starts at 15 minutes before anesthesia induction and ends at 15 minutes after anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| High-frequency | Experimental | The electrical stimulation is provided at a frequency of 100Hz Receives: Other: electrical acupoint stimulation |
| Low-frequency | Active comparator | The electrical stimulation is provided at a frequency of 2Hz Receives: Other: electrical acupoint stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline.
The MAP is continuously recorded by the DoCare Information System every 30 seconds. The AUC below baseline MAP is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX), where Sbaseline is the baseline MAP, Si is the MAP at minute i (i = 0.5, 1, 1.5, …, 15) after start of anesthesia induction, and ΔX is the time interval between measurements.
Measured: from start of induction to 15 minutes after induction
Secondary outcomes (7)
Incidence of hypotension during the induction period
Measured: from start of induction to 15 minutes after induction
The dosage of vasoactive drugs
Measured: from start of induction to 15 minutes after induction
The incidence of major complications (cardiovascular adverse events, acute kidney injury, delirium)
Measured: from end of surgery to discharge from the hospital, at an average of 5 days
Length of hospital stay
Measured: from end of surgery to discharge from the hospital, at an average of 5 days
The rate of patients admitted to the intensive care unit (ICU) after surgery
Measured: from end of surgery to discharge from the hospital, at an average of 5 days
The rate of patients achieving the best recovery after surgery (discharged within 5 days after surgery, without major complications, no incision infection, no readmission, and survive within 30 days after surgery)
Measured: from end of surgery to 30 days after surgery
The score of the discharge quality assessment scale
Quality of Recovery, QoR-15
15 items across 5 dimensions: physical comfort, physical independence, psychological support, emotional state, and pain.
Each item is scored from 0 to 10. The total score ranges from 0 to 150, with a higher score representing better recovery.
A change of 8 points or more is considered a Minimally Clinically Important Difference (MCID), meaning a meaningful improvement or decline from the patient's perspective.
Measured: at discharge from the hospital, at an average of 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start30 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve Replacement (TAVR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365345
- Sponsor's protocol ID
- XJH-A-20251111
- Acronym
- FRESH-T
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction in Patients Undergoing TAVR Surgery
- ClinicalTrials.gov ID
- NCT07365345
- Acronym / sponsor ID
- FRESH-T / XJH-A-20251111
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability, Anesthesia Induction, Electro-acupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan, Jian Shi, and Baihui. The changes in blood pressure during the anesthesia induction period were compared between the high-frequency group and the low-frequency group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-frequency | Experimental | Other: electrical acupoint stimulationThe electrical stimulation is provided at a frequency of 100Hz |
| Low-frequency | Active comparator | Other: electrical acupoint stimulationThe electrical stimulation is provided at a frequency of 2Hz |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The age of the patients is 60 years or older;
- Patients who are scheduled to undergo TAVR surgery under general anesthesia;
Key exclusion criteria (5 listed)
- Body mass index less than 18 kg/m2 or greater than 30 kg/m2;
- Hemodynamic instability (severe arrhythmia, decompensated heart failure);
- Hypotension after admission requiring intervention with vasoactive drugs;
- Severe liver or kidney dysfunction;
- Those who are contraindicated for electrical stimulation, including those with local skin damage, infection, or having implanted electrophysiological devices in the body.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical acupoint stimulationElectrical stimulation are administered at Neiguan, Jian Shi, and Baihui. The stimulation starts at 15 minutes before anesthesia induction and ends at 15 minutes after anesthesia induction. | Other | High-frequency, Low-frequency |
Primary outcome
The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline.
Time frame: from start of induction to 15 minutes after induction
The MAP is continuously recorded by the DoCare Information System every 30 seconds. The AUC below baseline MAP is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX), where Sbaseline is the baseline MAP, Si is the MAP at minute i (i = 0.5, 1, 1.5, …, 15) after start of anesthesia induction, and ΔX is the time interval between measurements.
7 secondary outcomes
Incidence of hypotension during the induction period
Time frame: from start of induction to 15 minutes after induction
The dosage of vasoactive drugs
Time frame: from start of induction to 15 minutes after induction
The incidence of major complications (cardiovascular adverse events, acute kidney injury, delirium)
Time frame: from end of surgery to discharge from the hospital, at an average of 5 days
Length of hospital stay
Time frame: from end of surgery to discharge from the hospital, at an average of 5 days
The rate of patients admitted to the intensive care unit (ICU) after surgery
Time frame: from end of surgery to discharge from the hospital, at an average of 5 days
The rate of patients achieving the best recovery after surgery (discharged within 5 days after surgery, without major complications, no incision infection, no readmission, and survive within 30 days after surgery)
Time frame: from end of surgery to 30 days after surgery
The score of the discharge quality assessment scale
Time frame: at discharge from the hospital, at an average of 5 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical acupoint stimulation in people with Transcatheter Aortic Valve Replacement (TAVR) and Hemodynamic Stability, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Lu (86-13891975018, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline. (time frame: from start of induction to 15 minutes after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.