Clinical trials: sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Septal Defect
Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.
- Trial name
- NCT05887700
- Testing
- CeraFlex™ Atrial Septal Defect (ASD) Closure System
- Where
- 10 sites in Brazil, Greece and 1 more
- Volunteers
- 145 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Non Valvular Atrial Fibrillation
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Worldwide, atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. The prevalence of AF gradually increases with age; its prevalence is 0.5% ~ 0.8% among 45 ~ 59 year-olds, 1.8% ~ 5.9% among 60 ~ 69 year-olds…
- Trial name
- LAmbre2 (NCT07455539)
- Testing
- LAmbre II Left Atrial Appendage Occluder
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Abdominal Aortic Aneurysms (AAA)
A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm
The objective of this clinical investigational study is to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (i.e., IE stent grafts with distal…
- Trial name
- NCT07754240
- Testing
- Ankura™ II Abdominal Aortic Stent Graft System
- Where
- Bulgaria
- Volunteers
- 45 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
Shenzhen Lifevalve Medical Scientific Co., Ltd. has developed a new X-Clip Mitral Valve Clip System and its compatible Steerable Guide System, aiming to provide transcatheter mitral valve repair for patients with degenerative…
- Trial name
- NCT07660185
- Testing
- X-Clip Treatment for Degenerative Mitral Regurgitation
- Where
- 3 sites in Spain
- Volunteers
- 15 people
- Sponsor
- Shenzhen Lifevalve Medical Scientific Co., Ltd.
Patent Ductus Arteriosus
HeartR™ PDA Occluder Post-Market Follow-Up Study
The HeartR™ PDA Occluder Post-Market Clinical Follow-up (PMCF) Study is a multi-center, retrospective, single-arm study sponsored by Lifetech Scientific (Shenzhen) Co., Ltd., aiming to evaluate the long-term safety and…
- Trial name
- NCT07646704
- Testing
- HeartR™ PDA Occluder
- Where
- Indonesia
- Volunteers
- 140 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Aneurysm, Endoleak
Cera™ Vascular Plug System Post-Market Clinical Follow-Up
The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: confirm the performance confirm the safety identify previously unknown side-effects monitor the…
- Conditions
- Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation, Portal Hypertension
- Trial name
- NCT06099015
- Testing
- Cera™ Vascular Plug System
- Where
- 9 sites in Germany, Italy and 1 more
- Volunteers
- 132 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Non-valvular Atrial Fibrillation (NVAF)
FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients
To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and…
- Trial name
- NCT07385599
- Testing
- LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Patent Foramen Ovale
CeraFlex PFO Closure System PMCF Study
The purpose of this study is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.
- Trial name
- NCT06120270
- Testing
- CeraFlex PFO Closure System
- Where
- 15 sites in Germany, South Korea
- Volunteers
- 180 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Thoracoabdominal Aortic Aneurysms
Thoracoabdominal Artery Stent Graft System Exploratory Study
This study is designed as a single-center, prospective, single-arm, open-label, exploratory study. The objective is to evaluate the feasibility of Thoracoabdominal Artery Stent Graft System for endovascular treatment of…
- Trial name
- NCT06710938
- Testing
- The system includes the G-Branch™ thoracoabdominal aortic stent graft system, the peripheral vascular stent graft system, and the aortic extension stent graft system
- Where
- Germany
- Volunteers
- 11 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Abdominal Aortic Aneurysm
Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
The objective of the study is to collect real-world data on patient outcomes and evaluate the safety and performance of the Lifetech Ankura™ AAA Stent Graft System, Ankura™ Cuff Stent Graft System, Ankura™ AUI Stent Graft System…
- Trial name
- NCT05864560
- Testing
- Ankura™ AAA Stent Graft System; Ankura™ Cuff Stent Graft System; Ankura™ AUI Stent Graft System
- Where
- 7 sites in Bulgaria, Greece and 1 more
- Volunteers
- 164 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Aneurysm Thoracic, Dissection of Thoracic Aorta
Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study
The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with…
- Trial name
- NCT05639569
- Testing
- Ankura™ TAA Stent Graft System
- Where
- 15 sites in Germany, Greece and 3 more
- Volunteers
- 147 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Septal Defect
Safety and Efficacy of the AbsnowTM II Absorbable Atrial Septal Defect Closure System for Atrial Septal Defect Closure Therapy
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the AbsnowTM II absorbable atrial septal defect occluder system for atrial septal defect closure therapy.
- Trial name
- NCT07529028
- Testing
- Absnow II Absorbable Atrial Septal Defect Occluder System, Cera Atrial Septal Defect Occluder
- Volunteers
- 236 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Heart Septal Defects, Atrial, Atrial Septal Defect
Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.
- Trial name
- NCT03601039
- Testing
- Absnow Absorbable ASD Closure System
- Where
- 14 sites in China
- Volunteers
- 165 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation
Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure
Atrial fibrillation (AF) is responsible for 15-20% of ischaemic strokes. These events are often caused by thrombus formation in the left atrium. Thromboembolic risk in AF is primarily prevented by oral anticoagulation.
- Trial name
- ESCALLE (NCT06465459)
- Testing
- LAMBRE device implantation
- Where
- France
- Volunteers
- 220 people
- Sponsor
- French Cardiology Society
Atrial Fibrillation, Left Atrial Appendage Thrombosis
Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF
The primary objective is to demonstrate the safety and efficacy of the implantation of the LAmbre PlusTM device in patients with large or irregularly shaped appendages with non-valvular atrial fibrillation who are at increased…
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Thrombosis, CVA
- Trial name
- CORRAL-AF (NCT04684212)
- Testing
- LAmbre PlusTM Left Atrial Appendage Closure System, Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)
- Where
- United States
- Sponsor
- Brian O'Neill MD
Aortic Arch Aneurysm, Penetrating Aortic Ulcer
Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
- Trial name
- NCT06520774
- Testing
- Concave Supra-arch Branched Stent-Graft System
- Where
- 17 sites in China, Germany
- Volunteers
- 103 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation
Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up Study
Multi-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate the immediate and long-term procedural success of Lifetech LAmbre™ occluders in patients.
- Trial name
- LISA (NCT03666780)
- Testing
- LAmbre Occluder
- Where
- 26 sites in China, Denmark and 7 more
- Volunteers
- 500 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Thoracoabdominal; Aortic, Aneurysm, Dissecting
Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.
- Trial name
- NCT05803564
- Testing
- Thoracoabdominal aortic stent system
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Thoracoabdominal Aortic Aneurysms
Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.
Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.
- Trial name
- NCT05054985
- Testing
- Multi-Branched Thoracoabdominal Stent Graft System
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Thoracic Aortic Dissection
Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY（PATENCY）
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Trial name
- NCT03767777
- Testing
- Artery Stent Graft System
- Where
- 21 sites in China
- Volunteers
- 150 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.