Clinical trials: Valve
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Stroke
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
- Trial name
- PROTECTED TAVR (NCT04149535)
- Testing
- Sentinel® Cerebral Protection System
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 3,000 people
- Sponsor
- Boston Scientific Corporation
Congenital Heart Diseases, Aortic Valve Disorder
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk population 2) to develop better understanding of…
- Trial name
- NCT01619982
- Testing
- Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride, Cefazolin 30 mg/kg body weight
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Stanford University
Glaucoma
Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery
To determine whether ranibizumab therapy before and after tube insertion for glaucoma surgeries can maintain the patency of the tube and prevent scar formation, and increase the chances for a successful procedure compared to…
- Trial name
- NCT00644280
- Testing
- Ranibizumab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of California, San Francisco
Transcatheter Aortic Valve Implantation
Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement
Implementation of Physical Therapy (PT) and Occupational Therapy (OT) pathway (initiation of services on Post procedure day #1 and continued daily with focus on education and activity progression) for all patients undergoing a…
- Trial name
- PTOTtAVR (NCT03117296)
- Testing
- Post procedure daily PT and OT, PT post procedure, OT post procedure
- Where
- United States
- Volunteers
- 189 people
- Sponsor
- Henry Ford Health System
Hypertrophic Cardiomyopathy, Sudden Cardiac Death
PRecIsion Medicine in CardiomyopathY
This is a retrospective cohort study of pediatric hypertrophic cardiomyopathy (HCM) patients using chart and registry review methodology.
- Trial name
- PRIMaCY (NCT04036799)
- Volunteers
- 572 people
- Sponsor
- The Hospital for Sick Children
Hypertrophic Cardiomyopathy
Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects
Mavacamten is a small-molecule allosteric inhibitor of cardiac myosin that reversibly inhibits its binding to cardiac actin, thereby relieving systolic hypercontractility and improving ventricular compliance.
- Trial name
- NCT05135871
- Testing
- Mavacamten
- Where
- China
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- LianBio LLC
Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery
Cardiac Rehabilitation Peer Mentorship
The current study is a randomized controlled trial, being conducted at two hospitals in Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an intervention group, in which they will receive mentorship…
- Conditions
- Percutaneous Coronary Intervention, Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery, Acute Coronary Syndrome, Chronic Stable Heart Failure
- Trial name
- NCT02204449
- Testing
- Cardiac Rehabilitation Peer Mentorship
- Where
- 2 sites in Canada
- Volunteers
- 94 people
- Sponsor
- University Health Network, Toronto
Aortic Stenosis, Aortic Valve Stenosis
SAPIEN 3 Ultra EU PMS
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating…
- Trial name
- NCT04860752
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 37 sites in Austria, Finland and 8 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Gastroesophageal Reflux Disease (GERD)
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling system for the treatment of GERD. The system allows the operator to staple the stomach to the esophagus,in order to restore the…
- Trial name
- NCT00734747
- Testing
- Medigus SRS endoscopic stapling system
- Where
- 6 sites in United States, Austria and 3 more
- Volunteers
- 72 people
- Sponsor
- Aviel Roy-Shapira, M.D.
Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement
Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education program at a community-based…
- Conditions
- Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement, Patients Waiting for Mitral Valve Repair or Replacement, Patients Waiting for Combined Procedures. (CAGB and Valve)
- Trial name
- PREHAB (NCT02219815)
- Testing
- Prehab Intervention
- Where
- 5 sites in Canada
- Volunteers
- 89 people
- Sponsor
- St. Boniface Hospital
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.
Aortic Stenosis
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
- Trial name
- NCT01876420
- Testing
- The CoreValve™ Evolut R TAV™ system
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Aortic Valve Disease, Mitral Valve Disease
Artificial Valve Endocarditis Reduction Trial
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
- Conditions
- Aortic Valve Disease, Mitral Valve Disease, Endocarditis
- Trial name
- AVERT (NCT00590889)
- Testing
- Artificial Mechanical Heart Valve
- Where
- 16 sites in United States, Canada and 6 more
- Volunteers
- 807 people
- Sponsor
- Abbott Medical Devices
Pulmonary Valve Insufficiency, Pulmonary Regurgitation
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction
- Trial name
- NCT00676689
- Testing
- SAPIEN Transcatheter Valve Implantation
- Where
- 7 sites in United States
- Volunteers
- 81 people
- Sponsor
- Edwards Lifesciences
Emphysema
Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)
The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.
- Trial name
- LIBERATE (NCT01796392)
- Testing
- EBV, Optimal Medical Management
- Where
- 23 sites in United States, Brazil and 2 more
- Volunteers
- 190 people
- Sponsor
- Pulmonx Corporation
Healthy Adults (Full Study and Extension Phase), Hypertrophic Cardiomyopathy or Dilated Cardiomyopathy
A Pilot Project Exploring the Impact of Whole Genome Sequencing in Healthcare
The MedSeq™ Project seeks to explore the impact of incorporating information from a patient's whole genome sequence into the practice of clinical medicine.
- Trial name
- NCT01736566
- Testing
- Family History + Whole Genome Sequencing, Family History Only
- Where
- United States
- Volunteers
- 213 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Aortic Stenosis
Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study
Currently, aortic stenosis (AS) is considered a "surgical disease" with no medical therapy available to improve any clinical outcomes, including symptoms, time to surgery, or long-term survival.
- Trial name
- ASPEN-AVR (NCT01272388)
- Testing
- Tadalafil
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Washington University School of Medicine
Cluster Headache
A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache
Cluster headache is a disorder marked by frequent attacks of short-lasting, severe, unilateral head pain with associated autonomic symptoms. It is the most severe head pain syndrome known.
- Trial name
- NCT01298921
- Testing
- Oxygen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Geisinger Clinic