Single Leaflet Device Attachment (SLDA) Rate
Primary
· up to 30 Days
SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device
| Group | Value | 95% CI |
|---|---|---|
| MitraClip NT System | 1.21 |
Last reviewed · How we verify
NCT03500692: MitraClip NT
MitraClip NT System Post-marketing Surveillance Study - Japan
Completed
Results posted
Last updated 23 July 2024
What this trial tests
trial testing MitraClip NT System in Mitral Regurgitation in 500 participants. Completed in 23 March 2022.
Timeline
2 April 2018
Primary endpoint
31 March 2019
31 March 2019
23 March 2022
Quick facts
| Lead sponsor | Abbott Medical Devices |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 2 April 2018 |
| Primary completion | 31 March 2019 |
| Estimated completion | 23 March 2022 |
| Sites | 40 locations across Japan |
Drugs / interventions tested
- MitraClip NT System
Conditions studied
- Mitral Regurgitation — all drugs for Mitral Regurgitation →
- Mitral Valve Regurgitation — all drugs for Mitral Valve Regurgitation →
Sponsor
Abbott Medical Devices — full company profile →
Who can join
18 and older, any sex, with Mitral Regurgitation or Mitral Valve Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
No of Participants With Acute Procedural Success (APS)
Primary
· up to 7 days (Discharge visit) from Procedure date
APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment. Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the
| Group | Value | 95% CI |
|---|---|---|
| MitraClip NT System | 452 |
Adverse events — posted to ClinicalTrials.gov
Time frame: This section includes Adverse events reported through 3 years. Subject follow-up is complete.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
MitraClip NT System
Serious: 322/500 (64%)
Deaths: 163/500
Serious adverse events (162 terms)
| Reaction | System | MitraClip NT System |
|---|---|---|
| Cardiac Failure | Cardiac disorders | — |
| Death | General disorders | — |
| Renal Failure | Renal and urinary disorders | — |
| Mitral Valve Incompetence | Cardiac disorders | — |
| Pneumonia | Infections and infestations | — |
| Haemorrhage | Vascular disorders | — |
| Ventricular Tachycardia | Cardiac disorders | — |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Mitral Valve Prolapse | Cardiac disorders | — |
| Ischaemic Stroke | Nervous system disorders | — |
| Atrial Septal Defect | Congenital, familial and genetic disorders | — |
| Sepsis | Infections and infestations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Haemorrhagic Stroke | Nervous system disorders | — |
| Pericardial Effusion | Cardiac disorders | — |
| Femur Fracture | Injury, poisoning and procedural complications | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Ventricular Fibrillation | Cardiac disorders | — |
| Cataract | Eye disorders | — |
| Compression Fracture | Injury, poisoning and procedural complications | — |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | — |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | — |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — |
| Arrhythmia | Cardiac disorders | — |
Other adverse events (21 terms — click to expand)
| Reaction | System | MitraClip NT System |
|---|---|---|
| Mitral Valve Stenosis | Cardiac disorders | — |
| Mitral Valve Incompetence | Cardiac disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Cardiac Failure | Cardiac disorders | — |
| Mitral Valve Prolapse | Cardiac disorders | — |
| Pneumonia | Infections and infestations | — |
| Thrombosis | Vascular disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Bradycardia | Cardiac disorders | — |
| Chordae Tendinae Rupture | Cardiac disorders | — |
| Pericardial Effusion | Cardiac disorders | — |
| Tachycardia | Cardiac disorders | — |
| Ventricular Tachycardia | Cardiac disorders | — |
| Atrial Septal Defect | Congenital, familial and genetic disorders | — |
| Influenza | Infections and infestations | — |
| Concussion | Injury, poisoning and procedural complications | — |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Hypotension | Vascular disorders | — |
| Peripheral Artery Aneurysm | Vascular disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Device Deployment Issue | General disorders | — |
Most-reported serious reactions: Cardiac Failure, Death, Renal Failure, Mitral Valve Incompetence, Pneumonia, Haemorrhage, Ventricular Tachycardia, Pneumonia Aspiration.
Data from ClinicalTrials.gov NCT03500692 adverse events section.
Sponsor's own description
The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03500692
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03500692 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
- Last refreshed: 23 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03500692.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing