Mitral RegurgitationNCT06227286
Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER)
A study testing EECP in people with Mitral Regurgitation, run by Sun Yat-sen University at 6 sites in China.
Trial summary
The goal of this multicenter, randomized, double-blind controlled study is to learn about the individuals after transcatheter edge-to-edge mitral valve repair (TEER). The main questions it aims to answer are: (1) can enhanced external counterpulsation (EECP) reduce the prevalence of afterload mismatch after TEER? (2)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- EECP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 6 sitesChina
- Study dates
- 1 Mar 2024to 31 Dec 2028
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent to participate
- Age > 18 years
- Moderate or severe Mitral Regurgitation
- Patients who meet the indications for transcatheter Mitral valve edge-to-edge repair and have undergone TEERM
Who cannot join
- Lower extremity deep vein thrombosis, active thrombophlebitis
- Moderate or severe aortic stenosis/insufficiency
- Moderate pulmonary hypertension (mean pulmonary pressure >50mmHg)
- Aortic aneurysm/cerebral aneurysm Uncontrolled hypertension (>180/110mmHg) Arrhythmias that may interfere with the ECG gating function of the EECP device Hemorrhagic disease or obvious bleeding tendency Limb infection Pregnant/lactating women
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Xiaodong Zhuang, PhD, +86 13760755035, zhuangxd3@mail.sysu.edu.cn
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Longgen Xiong, +8613922761639, xionglg66@126.com
Third Affiliated Hospital, Sun Yat-Sun University
Guangzhou, Guangdong, 510000
Zhuoshan Huang, PhD, +86 13728059476, huangzhsh@mail.sysu.edu.cn
Jieyang People's Hospital
Jieyang, Guangdong, 522000
Mingwei Xu, PhD, +86 13828186368, versy@163.com
Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Jilin Li, PhD, +86 13592852807, lijilin@126.com
Zhongshan People's Hospital
Zhongshan, Guangdong, 528400
Li Feng, PhD, +86 13902593410, lifengdoc@126.com
About this study
Official title: Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER): A Multicenter, Randomized, Double-blind Controlled Study
The goal of this multicenter, randomized, double-blind controlled study is to learn about the individuals after transcatheter edge-to-edge mitral valve repair (TEER). The main questions it aims to answer are: (1) can enhanced external counterpulsation (EECP) reduce the prevalence of afterload mismatch after TEER? (2) can EECP prevent the major adverse cardiac events after TEER? Participants will be randomly assigned into EECP or Sham-EECP intervention after TEER. Researchers will compare the EECP and Sham-EECP to see if it helps reduce the prevalence of afterload mismatch after TEER.
- Conditions
- Mitral Regurgitation
- Being tested
- EECP, Sham-EECP
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EECPDevice
EECP: 30-45 minutes/day, 5 days/week, 7 weeks, initiates with 0.030MPa.
Sham-EECPDevice
EECP: 30-45 minutes/day, 5 days/week, 7 weeks, constant to 75 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| EECP Arm | Experimental | Participants would be assigned for treating with EECP initiated with 0.030 MPa, 30-45 minutes per day, 5 days per week, 7 weeks in total. Receives: Device: EECP |
| Sham-EECP Arm | Sham comparator | Participants would be assigned for treating with Sham-EECP initiated with 70 mmHg, 30-45 minutes per day, 5 days per week, 7 weeks in total. Receives: Device: Sham-EECP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Afterload mismatch
postoperative-LVEF / preoperative-LVEF <85% OR postoperative-LVEDVi / preoperative-LVEDVi >110%
Measured: Within 1 years after transcatheter Mitral valve edge-to-edge repair
Secondary outcomes (1)
Major adverse composite events
Cardiovascular death, acute heart failure, hospitalization caused by chronic heart failure, myocardial infarction, unplanned coronary revascularization (PCI/PTCA/CABGs), stroke
Measured: Within 1 years after transcatheter Mitral valve edge-to-edge repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Shantou University Medical College, Second Affiliated Hospital of Guangzhou Medical University, Zhongshan People's Hospital, Guangdong, China, Jieyang People's Hospital
- Responsible party
- Principal investigator, Xiao-dong Zhuang, Sun Yat-sen University
- Investigators
- Xiaodong Zhuang, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227286
- Sponsor's protocol ID
- PAMPER Study
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER): A Multicenter, Randomized, Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT06227286
- Acronym / sponsor ID
- PAMPER Study
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Shantou University Medical College, Second Affiliated Hospital of Guangzhou Medical University, Zhongshan People's Hospital, Guangdong, China, Jieyang People's Hospital
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Jan 2024 (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.
The goal of this multicenter, randomized, double-blind controlled study is to learn about the individuals after transcatheter edge-to-edge mitral valve repair (TEER). The main questions it aims to answer are: (1) can enhanced external counterpulsation (EECP) reduce the prevalence of afterload mismatch after TEER? (2) can EECP prevent the major adverse cardiac events after TEER? Participants will be randomly assigned into EECP or Sham-EECP intervention after TEER. Researchers will compare the EECP and Sham-EECP to see if it helps reduce the prevalence of afterload mismatch after TEER.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EECP Arm | Experimental | Device: EECPParticipants would be assigned for treating with EECP initiated with 0.030 MPa, 30-45 minutes per day, 5 days per week, 7 weeks in total. |
| Sham-EECP Arm | Sham comparator | Device: Sham-EECPParticipants would be assigned for treating with Sham-EECP initiated with 70 mmHg, 30-45 minutes per day, 5 days per week, 7 weeks in total. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consent to participate
- Age > 18 years
- Moderate or severe Mitral Regurgitation
- Patients who meet the indications for transcatheter Mitral valve edge-to-edge repair and have undergone TEERM
Key exclusion criteria (4 listed)
- Lower extremity deep vein thrombosis, active thrombophlebitis
- Moderate or severe aortic stenosis/insufficiency
- Moderate pulmonary hypertension (mean pulmonary pressure >50mmHg)
- Aortic aneurysm/cerebral aneurysm Uncontrolled hypertension (>180/110mmHg) Arrhythmias that may interfere with the ECG gating function of the EECP device Hemorrhagic disease or obvious bleeding tendency Limb infection Pregnant/lactating women
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 |
|---|---|---|
| EECPEECP: 30-45 minutes/day, 5 days/week, 7 weeks, initiates with 0.030MPa. | Device | EECP Arm |
| Sham-EECPEECP: 30-45 minutes/day, 5 days/week, 7 weeks, constant to 75 mmHg. | Device | Sham-EECP Arm |
Primary outcome
Prevalence of Afterload mismatch
Time frame: Within 1 years after transcatheter Mitral valve edge-to-edge repair
postoperative-LVEF / preoperative-LVEF <85% OR postoperative-LVEDVi / preoperative-LVEDVi >110%
1 secondary outcome
Major adverse composite events
Time frame: Within 1 years after transcatheter Mitral valve edge-to-edge repair
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 5 Feb 2024.
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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.
Xiaodong Zhuang, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EECP in people with Mitral Regurgitation, run by Sun Yat-sen University at 6 sites 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. 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 Xiaodong Zhuang, PhD (+86 13760755035, zhuangxd3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Afterload mismatch (time frame: Within 1 years after transcatheter Mitral valve edge-to-edge repair). 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 5 Feb 2024.