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Device

Edwards SAPIEN 3 transcatheter heart valve for Mitral Valve Regurgitation

N/A

Waitlist Available

Led By Robert J Lederman, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up exit from the cardiac catheterization laboratory

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of the LAMPOON technique in TMVR for people with mitral valve heart problems.

Eligible Conditions

Mitral Valve Regurgitation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ exit from the cardiac catheterization laboratory

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~exit from the cardiac catheterization laboratory

This trial's timeline: 3 weeks for screening, Varies for treatment, and exit from the cardiac catheterization laboratory for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure

Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure

Trial Design

1Treatment groups

Experimental Treatment

Group I: Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical OptionExperimental Treatment2 Interventions

The LAMPOON procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Edwards SAPIEN 3 transcatheter heart valve

2017

N/A

~40

ASHI INTECC Astato XS 20

2017

N/A

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor

3,837 Previous Clinical Trials

47,851,595 Total Patients Enrolled

Robert J Lederman, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)

12 Previous Clinical Trials

813 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this trial still available?

"The details hosted on clinicaltrials.gov reveal that this particular trial is not presently open to new patients; it was initially published on June 20th 2017 and last updated March 21st 2022. Nonetheless, there are 18 other medical trials actively recruiting participants at the moment."

Answered by AI

Are there multiple Canadian facilities conducting this research project?

"Currently, 6 different clinical trial sites are available for potential participants. Of these centres, Atlanta, Detroit and Falls Church stand out as convenient locations to minimize the burden of travel."

Answered by AI

Recent research and studies

Journal of the American College of CardiologyJournal

Anterior Leaflet Laceration to Prevent Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement

Khan, Jaffar M., Vasilis C. Babaliaros, Adam B. Greenbaum, Jason R. Foerst, Shahram Yazdani, James M. McCabe, Gaetano Paone, et al.. 2019. “Anterior Leaflet Laceration to Prevent Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2019.02.076.

clinicaltrials.govStudy

NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation

2017. "NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03015194.