Clinical trials: Septal
Ventricular Septal Defect
Lifetech KONAR MFO Post-Market Clinical Follow-Up Study
The purpose of the study is to collect real-world data on patient outcomes and evaluate the procedural success and performance of the Lifetech KONAR-MF™ VSD Occluder for patients with ventricular septal defect (VSD).
- Trial name
- NCT04417712
- Testing
- KONAR-MF™ VSD Occluder
- Where
- 4 sites in Germany, Italy
- Volunteers
- 40 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Structural Heart Diseases, Atrial Septal Defect
Cardiac Interventional ICE Imaging Trial
The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones.
- Conditions
- Structural Heart Diseases, Atrial Septal Defect, Patent Foramen Ovale, Arrhythmias, Cardiac
- Trial name
- INTELICE (NCT06344494)
- Testing
- Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system, SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
- Where
- 4 sites in China
- Volunteers
- 130 people
- Sponsor
- ICE Intelligent Healthcare Co., Ltd
Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)
Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period
The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with…
- Trial name
- NCT06320483
- Testing
- Vibroacoustic device BARK VibroLUNG
- Where
- 5 sites in Kazakhstan
- Volunteers
- 310 people
- Sponsor
- Bark Technology LLP
Atrial Septal Defect, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Atrial Septal Defect, Patent Foramen Ovale
Post Market Registry of the CBSO
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD)…
- Trial name
- CBSO Registry (NCT04105595)
- Testing
- Septal defect closure
- Where
- Germany
- Volunteers
- 6 people
- Sponsor
- atHeart Medical
Septal Defect, Atrial
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT01711983
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- W.L.Gore & Associates
Secundum Atrial Septal Defects
Occlutech Septal Occluder (Figulla Flex II) Study
The objectives of the study are: To determine the efficacy of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects To determine the safety of the…
- Trial name
- NCT04488120
- Testing
- transcatheter closure of secundum atrial septal defects in patients
- Volunteers
- 175 people
- Sponsor
- Occlutech International AB
Septal Deformity, Nasal Obstruction
Clinical Extend Study to Evaluate Safety and Effectiveness of TnR Nasal Mesh for Correction of Nasal Septum on Patients
The purpose of this observation study is to evaluate long term safety and efficacy at 2~3 years after surgery on patients who have completed nasal septal deformity surgery using TnR Nasal Mesh.
- Trial name
- NCT04332575
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- T&R Biofab Co., Ltd.
Patent Foramen Ovale, Atrial Septal Defect
Lifetech CeraFlex™ Post-Market Surveillance Study
The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™…
- Conditions
- Patent Foramen Ovale, Atrial Septal Defect, Patent Ductus Arteriosus
- Trial name
- NCT02621528
- Testing
- CeraFlex
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 120 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Septal Defect
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
- Trial name
- NCT00650936
- Testing
- AMPLATZER Septal Occluder
- Where
- 51 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Heart Septal Defects, Ventricular
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with…
- Trial name
- NCT00583791
- Testing
- Device closure with the AMPLATZER Muscular VSD Occluder
- Where
- 11 sites in United States
- Volunteers
- 91 people
- Sponsor
- Abbott Medical Devices
Migraine Disorders, Heart Septal Defects, Atrial
ESCAPE Migraine Trial
The purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who…
- Trial name
- NCT00267371
- Testing
- PFO Closure with Premere investigational device., Medical management/current medications per standard of care by personal physician.
- Where
- 37 sites in United States
- Volunteers
- 168 people
- Sponsor
- Abbott Medical Devices
Membranous Ventricular Septal Defects
Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER
The purpose of this feasibility study is to investigate the safety of the AMPLATZER® Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous Ventricular Septal Defects.
- Trial name
- NCT00578708
- Testing
- AMPLATZER Membranous VSD Occluder
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Abbott Medical Devices
Membranous, Ventricular
Emergency/Compassionate Use - Membranous VSD Occluder
Emergency/Compassionate use of the AMPLATZER Membranous VSD Occluder
- Conditions
- Membranous, Ventricular, Septal, Defects
- Trial name
- NCT00583505
- Testing
- Device closure with the AMPLATZER Membranous VSD Occluder
- Sponsor
- Abbott Medical Devices
Muscular, Ventricular
Emergency/Compassionate Use - Muscular VSD Occluder
Expanded access to the AMPLATZER Muscular VSD Occluder
- Conditions
- Muscular, Ventricular, Septal, Defects
- Trial name
- NCT00590382
- Testing
- AMPLATZER Muscular VSD Occluder
- Sponsor
- Abbott Medical Devices
Atrial Septal Defect Secundum
ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)
- Trial name
- ASO 522 (NCT02353351)
- Testing
- atrial septal occluder
- Where
- 65 sites in United States
- Volunteers
- 602 people
- Sponsor
- Abbott Medical Devices
Heart Septal Defects, Ventricular
Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System
The Ventricular septal defect (VSD) is the most common of all congenital cardiac malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System was designed.
- Trial name
- pfm-01/2005 (NCT00390702)
- Testing
- transcatheter implantation of a VSD occluder (Nitinol coil)
- Where
- 6 sites in Germany, Israel
- Volunteers
- 103 people
- Sponsor
- pfm medical gmbh
Atrial Septal Defect (ASD), Patent Foramen Ovale (PFO)
FIH Study With CBSO
The objective of this study is to evaluate the effectiveness and the safety of the intracardiac septal closure device (CBO), as well as the practicability of implantation of this device using the accessories (DS for CBO).
- Trial name
- NCT01960491
- Testing
- Device Closure of Atrial Septal Defect
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Carag AG
Septal Defect, Atrial
Long-term Safety Study of the GORE® HELEX® Septal Occluder
The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT00581308
- Testing
- GORE® HELEX® Septal Occluder
- Where
- United States
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Foramen Ovale, Patent, Septal Defect, Atrial
Stitch Closure of PFO and Septal Repair
The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal…
- Conditions
- Foramen Ovale, Patent, Septal Defect, Atrial, Septal Defect, Heart
- Trial name
- STITCH (NCT03373929)
- Testing
- PFO Closure Rate, Published PFO Device Closure
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- HeartStitch.Com