Trial Outcomes & Findings for MitraClip China PMS (NCT NCT04259411)
NCT ID: NCT04259411
Last Updated: 2025-12-15
Results Overview
APS is defined as successful implantation of the MitraClip device(s) with resulting MR severity of 2+ or less as determined by the ECL assessment of a discharge echocardiogram (30-day echocardiogram will be used if discharge echocardiogram is unavailable or uninterpretable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Discharge/30days
Results posted on
2025-12-15
Participant Flow
A total 51 subjects were enrolled across five investigational sites between December 6, 2021, and April 15th, 2024 and follow-up at discharge, 30 days and 1 year.
Participant milestones
| Measure |
MitraClip
Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
30 days
|
49
|
|
Overall Study
1 year
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
MitraClip
Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Missed visit
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MitraClip
n=51 Participants
Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.
|
|---|---|
|
Age, Continuous
|
72.0 years
STANDARD_DEVIATION 7.7 • n=51 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=51 Participants
|
|
Region of Enrollment
China
|
51 participants
n=51 Participants
|
|
Weight
|
60.2 kg
STANDARD_DEVIATION 13.8 • n=51 Participants
|
|
Body Mass Index
|
22.6 kg/m²
STANDARD_DEVIATION 4.1 • n=51 Participants
|
|
Heart Rate
|
74.1 beats per minute
STANDARD_DEVIATION 12.7 • n=51 Participants
|
|
Systolic Blood Pressure
|
120.2 mmHg
STANDARD_DEVIATION 19.7 • n=51 Participants
|
|
Diastolic Blood Pressure
|
69.9 mmHg
STANDARD_DEVIATION 11.3 • n=51 Participants
|
PRIMARY outcome
Timeframe: Discharge/30daysPopulation: The analysis population included all eligible and consented subjects implanted with a MitraClip device. The TTE images at discharge and 30 days were not evaluable by the echo core lab in 2 subjects, hence APS was evaluable for 49 subjects
APS is defined as successful implantation of the MitraClip device(s) with resulting MR severity of 2+ or less as determined by the ECL assessment of a discharge echocardiogram (30-day echocardiogram will be used if discharge echocardiogram is unavailable or uninterpretable).
Outcome measures
| Measure |
MitraClip
n=49 Participants
Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.
|
|---|---|
|
Percentage of Participants With Acute Procedural Success (APS)
|
93.9 percentage of participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The analysis population included all eligible and consented subjects implanted with a MitraClip device.
A Major Adverse Event (MAE) was determined as the composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device- or procedure-related adverse events occurring after the femoral vein puncture for transseptal access.
Outcome measures
| Measure |
MitraClip
n=51 Participants
Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.
|
|---|---|
|
Percentage of Participants With Freedom From Major Adverse Event (MAE)
|
100.0 percentage of participants
|
Adverse Events
MitraClip
Serious events: 16 serious events
Other events: 25 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MitraClip
n=51 participants at risk
Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
3.9%
2/51 • 1 year
|
|
Cardiac disorders
Atrial Fibrillation
|
5.9%
3/51 • 1 year
|
|
Cardiac disorders
Cardiac Arrest
|
2.0%
1/51 • 1 year
|
|
Cardiac disorders
Cardiac Failure
|
5.9%
3/51 • 1 year
|
|
Cardiac disorders
Cardiac Failure Chronic
|
2.0%
1/51 • 1 year
|
|
Cardiac disorders
Coronary Artery Disease
|
3.9%
2/51 • 1 year
|
|
Cardiac disorders
Left Ventricular Failure
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
Enteritis
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
Inguinal Hernia
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
2.0%
1/51 • 1 year
|
|
General disorders
Death
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
Covid-19
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
Endocarditis
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
Respiratory Tract Infection
|
2.0%
1/51 • 1 year
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
2.0%
1/51 • 1 year
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
3.9%
2/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
Cerebrovascular Accident
|
3.9%
2/51 • 1 year
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
2.0%
1/51 • 1 year
|
|
Renal and urinary disorders
Renal Failure
|
2.0%
1/51 • 1 year
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
2.0%
1/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.0%
1/51 • 1 year
|
|
Surgical and medical procedures
Aortic Aneurysm Repair
|
2.0%
1/51 • 1 year
|
Other adverse events
| Measure |
MitraClip
n=51 participants at risk
Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.9%
2/51 • 1 year
|
|
Metabolism and nutrition disorders
Hypoproteinemia
|
2.0%
1/51 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
2/51 • 1 year
|
|
Nervous system disorders
Carotid Arteriosclerosis
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
Lacunar Infarction
|
2.0%
1/51 • 1 year
|
|
Nervous system disorders
Transient Ischemic Attack
|
2.0%
1/51 • 1 year
|
|
Psychiatric disorders
Delirium
|
2.0%
1/51 • 1 year
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/51 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
5.9%
3/51 • 1 year
|
|
Renal and urinary disorders
Hydronephrosis
|
2.0%
1/51 • 1 year
|
|
Renal and urinary disorders
Renal Failure
|
3.9%
2/51 • 1 year
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
2.0%
1/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.0%
1/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.9%
2/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Calcification
|
2.0%
1/51 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
2.0%
1/51 • 1 year
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.9%
2/51 • 1 year
|
|
Vascular disorders
Hemorrhage
|
2.0%
1/51 • 1 year
|
|
Vascular disorders
Hypertension
|
9.8%
5/51 • 1 year
|
|
Vascular disorders
Hypotension
|
3.9%
2/51 • 1 year
|
|
Infections and infestations
COVID-19
|
3.9%
2/51 • 1 year
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
Pneumonia
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
Post Procedural Infection
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
Respiratory Tract Infection
|
5.9%
3/51 • 1 year
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.9%
3/51 • 1 year
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
2.0%
1/51 • 1 year
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
2.0%
1/51 • 1 year
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
2.0%
1/51 • 1 year
|
|
Injury, poisoning and procedural complications
Subdural Hematoma
|
2.0%
1/51 • 1 year
|
|
Investigations
Weight Decreased
|
2.0%
1/51 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.9%
2/51 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
11.8%
6/51 • 1 year
|
|
Cardiac disorders
Mitral Valve Incompetence
|
7.8%
4/51 • 1 year
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
2.0%
1/51 • 1 year
|
|
Endocrine disorders
Thyroid Mass
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
Abdominal Distension
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
Chronic Gastritis
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
3.9%
2/51 • 1 year
|
|
Gastrointestinal disorders
Functional Gastrointestinal Disorder
|
2.0%
1/51 • 1 year
|
|
General disorders
Chest Pain
|
3.9%
2/51 • 1 year
|
|
General disorders
Decreased Activity
|
2.0%
1/51 • 1 year
|
|
General disorders
Hypothermia
|
2.0%
1/51 • 1 year
|
|
General disorders
Hepatic Failure
|
2.0%
1/51 • 1 year
|
|
Infections and infestations
Bronchitis
|
2.0%
1/51 • 1 year
|
Additional Information
Janani Aiyer/ Clinical Scientist II
Abbott Structural Heart
Phone: +1(669)287-4507
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Following the earliest of: Sponsor's Study Results Disclosure; or 12 months after study completion or termination at all sites, PI shall publish results. PI shall provide Sponsor, 60 days before submission for publication, with a draft to ascertain if patentable subject matter or Sponsor Confidential Information are disclosed. Sponsor shall return comments to PI within 60 days after receipt of draft. PI shall delay publication another 60 days if Sponsor requests for proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER