Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/27/2019 |
| Start Date: | December 2015 |
| End Date: | January 2023 |
| Contact: | TMTT Clinical |
| Email: | TMTT_Clinical@edwards.com |
| Phone: | 949-250-2500 |
The study is a multi-center, prospective, early feasibility study to measure individual
patient clinical outcomes and effectiveness, evaluate the safety and function, provide
guidance for future clinical study designs and development efforts of the Edwards FORMA
Tricuspid Transcatheter Repair System.
patient clinical outcomes and effectiveness, evaluate the safety and function, provide
guidance for future clinical study designs and development efforts of the Edwards FORMA
Tricuspid Transcatheter Repair System.
The early feasibility study of the Edwards FORMA Tricuspid Transcatheter Repair System is a
multi-center, prospective, early feasibility study to measure individual patient clinical
outcomes and effectiveness, evaluate the safety and function, provide guidance for future
clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter
Repair System.
Data collected in this clinical study will include safety and function of the investigational
system as well as up to 3 year clinical outcomes.
multi-center, prospective, early feasibility study to measure individual patient clinical
outcomes and effectiveness, evaluate the safety and function, provide guidance for future
clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter
Repair System.
Data collected in this clinical study will include safety and function of the investigational
system as well as up to 3 year clinical outcomes.
Inclusion Criteria:
1. ≥ eighteen (18) and ≤ eighty five (85) years old
2. Clinically significant, symptomatic, functional, tricuspid regurgitation (per
applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by
the local Heart Team
Exclusion Criteria:
1. Tricuspid valve/right heart anatomy not suitable for the study device
2. Moderate or greater tricuspid valve stenosis
3. Severe RV dysfunction
We found this trial at
5
sites
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Rajendra Makkar, MD
Phone: 310-423-3977
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Vasilis Babaliaros, MD
Phone: 404-712-0131
Emory University Hospital As the largest health care system in Georgia and the only health...
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Morristown, New Jersey 07962
Principal Investigator: John M Brown, MD
Phone: 973-971-7541
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Susheel K Kodali, MD
Phone: 212-342-1820
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Rochester, Minnesota 55905
Principal Investigator: Mackram Eleid, MD
Phone: 507-538-3529
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