Clinical trials: Percutaneous Repair
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation
MitraClip® Registry
Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients.
- Trial name
- NCT02033811
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Abdominal Aortic Aneurysm
Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
The sudy purpose is to investigate efficacy and safety of percutaneous endovascular aortic aneurysm repair using INCRAFT stent graft for Korean patients with abdominal aortic aneurysm.
- Trial name
- NCT03952780
- Where
- South Korea
- Volunteers
- 86 people
- Sponsor
- Yonsei University
Epilepsy (treatment Refractory)
Percutaneous Repair for Drug - Resistant Epilepsy by Intervention of Closing the Patent Foramen Ovale（PREDICT-PFO Trial）
Patent foramen ovale (PFO) is the most common cause of right-to-left shunt (RLS) in the adult heart, with a prevalence of approximately 25% in the general population.
- Trial name
- PREDICT-PFO (NCT06863350)
- Testing
- patent foramen ovale closure
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Sichuan University
Mitral Regurgitation, Mitral Valve Regurgitation
A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair.
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Functional Mitral Regurgitation
- Trial name
- CINCH-2 (NCT00800046)
- Testing
- AccuCinch® Ventriculoplasty System
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 16 people
- Sponsor
- Ancora Heart, Inc.
Acute Rupture of Achilles Tendon
Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound
This is a prospective randomized controlled study carried out between May 2016 and December 2020. It included 98 patients presented with acute rupture of Achilles tendon The patients were randomly distributed by closed envelop…
- Trial name
- NCT04935281
- Testing
- percutaneous repair with an intraoperative assisted ultrasound, percutaneous repair without an intraoperative assisted ultrasound
- Volunteers
- 91 people
- Sponsor
- Tanta University
Tricuspid Valve Regurgitation
MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
- Trial name
- NCT04071652
- Testing
- Mistral implantation
- Where
- 3 sites in Israel
- Volunteers
- 17 people
- Sponsor
- Mitralix
Abdominal Aortic Aneurysm, Infrarenal Abdominal Aortic Aneurysm
Fast-Track Protocol for Endovascular Aneurysm Repair (EVAR) of Infrarenal Abdominal Aortic Aneurysms
The study aims to evaluate the clinical and economic efficacy of a "Fast-Track" protocol for the elective endovascular treatment (EVAR) of infrarenal abdominal aortic aneurysms (AAA).
- Conditions
- Abdominal Aortic Aneurysm, Infrarenal Abdominal Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs), Iliac Aneurysm
- Trial name
- NCT07431047
- Volunteers
- 50 people
- Sponsor
- University of Bologna
Mitral Valve Regurgitation
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation…
- Trial name
- PRIMARY (NCT05051033)
- Testing
- Mitral valve repair, Transcatheter edge-to-edge repair
- Where
- 66 sites in United States, Canada and 3 more
- Volunteers
- 450 people
- Sponsor
- Annetine Gelijns
Functional Mitral Regurgitation, Heart Failure
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
- Conditions
- Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases
- Trial name
- NCT03142152
- Testing
- Carillon Mitral Contour System, Guideline Directed Heart Failure Medication
- Where
- 92 sites in United States, Canada and 6 more
- Volunteers
- 300 people
- Sponsor
- Cardiac Dimensions, Inc.
Mitral Valve Insufficiency, Heart Failure
Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart…
- Trial name
- REDUCE FMR (NCT02325830)
- Testing
- Carillon Mitral Contour System
- Where
- 31 sites in Australia, Czechia and 6 more
- Volunteers
- 163 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Percutaneous Transluminal Angioplasty, Wound Heal
Measurement of Revascularization Effect Using NIRS in BTK Arteries
Patient with occluded below the knee arteries and chronic limb ischemia Rutherford class V-VI are enrolled. During endovascular recanalisation procedure changes in tissue oxygen amount is recorded using near infrared spectroscopy…
- Conditions
- Percutaneous Transluminal Angioplasty, Wound Heal, Ischemic Feet
- Trial name
- NCT03898869
- Testing
- Intraoperative NIRS monitoring
- Where
- Lithuania
- Volunteers
- 30 people
- Sponsor
- Vilnius University
Tricuspid Regurgitation
Evaluation of Tricuspid Valve Percutaneous Repair System in the Treatment of Severe Secondary Tricuspid Disorders
Tricuspid regurgitation (TR) is a long-overdue valvular pathology. Its prevalence is significant and increasing with the aging of the population.
- Trial name
- TRI-FR (NCT04646811)
- Testing
- Tricuspid valve, Best medical treatment
- Where
- 26 sites in Belgium, France
- Volunteers
- 300 people
- Sponsor
- Rennes University Hospital
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Aortic Aneurysm
Economic Comparison of Percutaneous (pEVAR) vs. Open Access in EVAR.
The present clinical trial is performed in the field of vascular surgery. The aim of the study is the economical and clinical comparison of two different access ways to the femoral artery with intention of endovascular repair of…
- Trial name
- EVAccess (NCT02822560)
- Testing
- pEVAR, open femoral access
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Wilhelminenspital Vienna
Coronary Artery Disease, Aortic Atherosclerotic Disease
Evaluation of One-stop Strategy of EVAR and PCI
The study is designed to evaluate the safety and effectiveness of the "one-stop" endovascular intervention strategy for patients with concomitant coronary artery disease and aortic atherosclerotic disease.
- Trial name
- NCT03540342
- Testing
- One stop strategy group
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Tricuspid Regurgitation Functional
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following…
- Trial name
- NCT04890821
- Testing
- CI Percutaneous Ring Annuloplasty System
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cardiac Implants LLC
Mitral Valve Regurgitation
MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Mitral Regurgitation.
- Trial name
- MERIT (NCT02948231)
- Testing
- Mistral implantation
- Where
- Belgium
- Volunteers
- 4 people
- Sponsor
- Mitralix
Cardiovascular Diseases
Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation
The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of…
- Trial name
- MITRA-FR (NCT01920698)
- Testing
- Percutaneous MitraClip Device Implantation, control
- Where
- 40 sites in France
- Volunteers
- 304 people
- Sponsor
- Hospices Civils de Lyon
Mitral Valve Prolapse, Left Ventricular Fibrosis
PRIMARY Ancillary Substudy
The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological…
- Conditions
- Mitral Valve Prolapse, Left Ventricular Fibrosis, Ventricular Arrhythmias
- Trial name
- NCT07103733
- Testing
- Cardiac Magnetic Resonance Imaging, ZioPatch Monitoring, Myocardial Tissue Biopsy
- Where
- 25 sites in United States, Germany and 1 more
- Volunteers
- 250 people
- Sponsor
- Annetine Gelijns