Clinical trials: Septal
Deviated Nasal Septum
ENTact™ Septal Stapler Shelf Life Extension
This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life.
- Trial name
- SSLE (NCT00957502)
- Testing
- ENTact™ Septal Stapler
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- ENTrigue Surgical, Inc.
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
Post-Infarction Ventricular Septal Defect
The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017.
- Trial name
- PIVSD PAS (NCT03165526)
- Testing
- AMPLATZER™ Post-infarct Muscular VSD Occluder
- Where
- 17 sites in United States
- Volunteers
- 131 people
- Sponsor
- Abbott Medical Devices
HOCM, Hypertrophic Obstructive Cardiomyopathy
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures…
- Trial name
- VALOR-HCM (NCT04349072)
- Testing
- Mavacamten
- Where
- 21 sites in United States
- Volunteers
- 112 people
- Sponsor
- Bristol-Myers Squibb
Patent Foramen Ovale (PFO)
Safety and Efficacy of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the efficacy and safety of the patent foramen ovale suture system in the closure treatment of patent foramen ovale.
- Trial name
- NCT07726927
- Testing
- Patent Foramen Ovale Suture System, Amplatzer PFO Occluder
- Volunteers
- 244 people
- Sponsor
- Shenzhen Bihe Medical Co., Ltd
Patent Foramen Ovale
Study on the Safety and Effectiveness of the SnowyTM PFO Closure System
To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale
- Trial name
- NCT05360771
- Testing
- SnowyTM PFO closure system, Cardi-o-fix PFO occluder
- Where
- China
- Volunteers
- 242 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Nasal Septal Deviation
EFS of Bioabsorbable Implant for NSD
Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation
- Trial name
- NCT05967169
- Testing
- Nasal Septal Strap implantation
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Spirair, Inc
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
PFO, PFO - Patent Foramen Ovale
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a…
- Conditions
- PFO, PFO - Patent Foramen Ovale, Cryptogenic Stroke, Patent Foramen Ovale
- Trial name
- PROTEA-PFO (NCT07172464)
- Testing
- Recross P3 Occluder (P3O) System
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Recross Cardio, Inc.
Heart Failure
Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter…
- Trial name
- CASSINI-EU (NCT06414265)
- Testing
- Transcatheter mitral valve replacement
- Where
- 8 sites in Georgia, Italy and 3 more
- Volunteers
- 30 people
- Sponsor
- InnovHeart
Patent Foramen Ovale, Stroke
PFO ACCESS Registry
Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.
- Trial name
- NCT00583401
- Testing
- Device closure with the AMPLATZER PFO Occluder
- Sponsor
- Abbott Medical Devices
Heart Diseases, Atrial Fibrillation
Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access
This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture.
- Trial name
- NCT06386458
- Testing
- AThrough radiofrequency transseptal puncture system, Traditional mechanical transseptal puncture needle
- Where
- 4 sites in China
- Volunteers
- 177 people
- Sponsor
- Hangzhou NOYA MedTech Co. Ltm.
Atrial Septal Defect
Cera™ ASD Occluder Post-Market Clinical Follow-Up Study
The objective of this post-market study is to: collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder identify previously unknown side-effects
- Trial name
- NCT06849635
- Where
- 6 sites in Poland
- Volunteers
- 139 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
AF Septal Pacing (Clinical Investigation Plan)
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum.
- Trial name
- NCT03242941
- Testing
- Pulmonary vein ablation
- Where
- 3 sites in Hungary, Netherlands
- Volunteers
- 16 people
- Sponsor
- Medtronic BRC
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Hummingbird ICE Study
The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of…
- Conditions
- ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF), Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT07552272
- Testing
- ICE Image Guidance
- Volunteers
- 1,000 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Septoplasty
Safety and Performance of ENTACT Septal Staple System for Septoplasty
This is a prospective, multi-center, single arm PMCF study to evaluate the safety and performance of the ENTACT (Next Generation) resorbable staple system for septoplasty in 40 subjects.
- Trial name
- NCT04392583
- Testing
- ENTACT Septal Staple system
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Smith & Nephew, Inc.
Atrial Septal Defect
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
- Trial name
- ASSURED (NCT02985684)
- Testing
- GORE® CARDIOFORM ASD Occluder
- Where
- 22 sites in United States
- Volunteers
- 125 people
- Sponsor
- W.L.Gore & Associates
Heart Block, Sick Sinus Syndrome
Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle…
- Conditions
- Heart Block, Sick Sinus Syndrome, Atrioventricular Block, Ventricular Dysfunction
- Trial name
- NCT01798043
- Testing
- Cardiac MRI with pacemaker stimulation, Cardiac MRI with and without pacemaker stimulation
- Where
- Switzerland
- Volunteers
- 29 people
- Sponsor
- Abbott Medical Devices
Nasal Septal Deviation, Nasal Airway Obstruction
Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
- Trial name
- NCT06163404
- Testing
- Implantation of Spirair Nasal Device using the Spirair delivery system.
- Where
- 8 sites in United States
- Volunteers
- 102 people
- Sponsor
- Spirair, Inc