CAP-TEER: CerebrAl Protection During Transcatheter Edge-to-edge Repair

Launched by XIAO-DONG ZHUANG · Feb 5, 2025

Keywords

ClinConnect Summary

The CAP-TEER trial is studying a new approach to help protect the brain during a specific heart procedure called transcatheter edge-to-edge repair (M-TEER). This procedure is often used for patients with severe mitral regurgitation, a condition where the heart's mitral valve doesn't close properly, leading to blood flow issues. While M-TEER is a good option for patients who can’t have traditional surgery due to high risks, it can sometimes lead to strokes or brain injuries. The trial aims to see if using a special device to protect the brain during the procedure can make it safer.

To participate in this trial, individuals must be at least 18 years old and diagnosed with severe mitral regurgitation that causes noticeable symptoms. They also need to be scheduled for the M-TEER procedure and agree to join the study, including follow-up visits. However, there are some health conditions that could prevent someone from joining, such as recent heart surgeries, certain breathing issues, or if they have a life expectancy of less than one year. Participants can expect to be randomly assigned to either receive the brain protection device during their procedure or to have the standard procedure without it. This trial is not yet recruiting, but it represents an important step toward making heart treatments safer for patients at risk.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects must meet ALL of the following criteria:
• • General Inclusion Criteria
• • Age ≥18 years
• • Severe Mitral Regurgitation (3+ to 4+)
• • Symptom status: NYHA functional class ≥ II
• • Subjects scheduled to receive the M-TEER per the current approved indications for use
• • Subjects agreed to join the study and complete follow-up
• Exclusion Criteria:
• Potential Subjects will be excluded if ANY of the following criteria apply:
• • General Exclusion Criteria
• • Contraindication to MRI
• • CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days
• • Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
• • COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
• • Cerebrovascular accident within prior 30 days
• • Severe symptomatic carotid stenosis (\>70% by ultrasound)
• • Carotid surgery or stenting within prior 30 days
• • Hemodynamic instability requiring inotropic support or mechanical heart assistance
• • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
• • Contraindication for transesophageal echocardiography
• • Life expectancy \< 1 year
• • Pregnant or planning pregnancy within next 12 months
• • Participation in another interventional Trial
• • Patients who are not able to give consent or complete the follow-up