Cardiovalve Transfemoral System - FIM Study
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|ClinicalTrials.gov Identifier: NCT03958773|
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mitral Regurgitation||Device: Cardiovalve system||Not Applicable|
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
The purpose of this study is to evaluate the safety of the CardiovalveSystem with its associated procedure, and observe the device performance in reducing mitral regurgitation Data collected in this clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, single-center, single-arm feasibility clinical study.|
|Masking:||None (Open Label)|
|Official Title:||Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation|
|Actual Study Start Date :||October 12, 2017|
|Estimated Primary Completion Date :||September 12, 2020|
|Estimated Study Completion Date :||September 12, 2021|
|Experimental: Cardiovalve treatment||
Device: Cardiovalve system
Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.
- Freedom from major device or procedure related serious adverse events [ Time Frame: 30 days ]
Freedom from major device or procedure related serious adverse events:
F. Stage 2 or 3 acute kidney injury (includes new dialysis) H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for >48 h.
I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
- Technical success [ Time Frame: Intraoperative ]Technical success; delivery and deployment of the device in the correct position and retrieval of delivery catheter, without significant mitral stenosis, LVOT obstruction or paravalvular MR documented by intraoperative imaging
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958773
|Contact: Nitza Shoham, PhD||+972765388142 ext email@example.com|
|Contact: Ronit Pickfirstname.lastname@example.org|
|Hospital of the Lithuanian University of Health Sciences ligoninė Kauno||Recruiting|
|Contact: Rimantas Benetis, MD|
|Principal Investigator:||Rimantas Benetis, MD||Head of department|