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Percutaneous mitral valve clip therapy for high-risk mitral regurgitation patients who are not candidates for open heart surgery

Percutaneous mitral valve clip therapy for high-risk mitral regurgitation patients who are not candidates for open heart surgery

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-12002909
Enrollment
Unknown
Registered
2012-12-18
Start date
2010-10-15
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral regurgitation

Interventions

1:Percutaneous mitral valve clip therapy

Sponsors

Abbott Vascular Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Moderate to severe (grade 3) or severe (grade 4) chronic mitral valve regurgitation; not a candidate for mitral valve surgery (patient declined surgery or the operation has been turned down by surgeon) andsymptomatic with LVEF > 25% and LVIDs 50mmHg at rest or >60mmHg with exercise

Exclusion criteria

Exclusion criteria: 1. Patients not able to give informed consent; 2. Patients cannot tolerate transesophageal echocardiogram; 3. Patients with advanced chronic kidney disease with serum creatinine of greater than 2mg/dl or end stage renal disease; 4. Patients who has intracardiac thrombus detected by TEE; 5. Mitral valvular area assessed by echocardiography less than 4cm2.

Design outcomes

Primary

MeasureTime frame
Acute procedure success (defined as reduction of MR to 2+) immediately after implantation;A composite of adverse events including death, major stroke, reoperation 1 month after procedure;A composite of adverse events including urgent/emergent surgery 1 month after procedure;A composite of adverse events including myocardial infarction, renal failure 1 month after procedure;A composite of adverse events including the need for blood transfusion 1 month after procedure;

Countries

China

Contacts

Public ContactProfessor Lam Yat Yin
yylam@cuhk.edu.hk+852 2632 1299

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026