Clinical trials: Ventricular
ICD, Sudden Cardiac Death
Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
The purpose of the THORN registry is to show the ability of Home-Monitoring® to early identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients (i.e.
- Conditions
- ICD, Sudden Cardiac Death, Ventricular Fibrillation, Atrial Fibrillation
- Trial name
- THORN (NCT01594112)
- Where
- 55 sites in France
- Volunteers
- 512 people
- Sponsor
- Biotronik SE & Co. KG
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
Heart Failure
EASYTRAK 4 Steerable LV Lead
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
- Trial name
- NCT00158964
- Testing
- EASYTRAK 4 STEERABLE LV lead
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Boston Scientific Corporation
Pulmonary Hypertension Associated With HFpEF
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular…
- Trial name
- LEVEL-2 (NCT07288398)
- Testing
- TNX-103
- Where
- 140 sites in United States, Argentina and 13 more
- Volunteers
- 540 people
- Sponsor
- Tenax Therapeutics, Inc.
PAH
CXA-10 Study in Subjects With Pulmonary Arterial Hypertension
This is a Phase 2, multicenter, open-label extension (OLE) of study CXA-10-301, to evaluate the long term safety and efficacy of daily dosing of CXA-10.
- Trial name
- NCT04053543
- Testing
- CXA-10
- Where
- 37 sites in United States, United Kingdom
- Volunteers
- 33 people
- Sponsor
- Complexa, Inc.
Aortic Valve Disease, Aortic Valve Stenosis
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
- Trial name
- VITAL (NCT05977257)
- Testing
- VitaFlow® Transcatheter Aortic Valve Replacement System
- Where
- 4 sites in China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Severe Symptomatic Aortic Stenosis
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
- Trial name
- Portico TA EU (NCT01742598)
- Testing
- Portico Transapical Aortic Valve System
- Where
- United Kingdom
- Sponsor
- Abbott Medical Devices
Primary Prevention, Tachycardia, Ventricular
Survival of Patients With Primary Prophylactic ICD Indication
The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD).
- Conditions
- Primary Prevention, Tachycardia, Ventricular, Sudden Cardiac Death
- Trial name
- SPIRIT-ICD (NCT00619593)
- Testing
- Intensified diagnostic and treatment measures following 1st appropriate ICD therapy, Standard follow-up
- Where
- 37 sites in Austria, Czechia and 9 more
- Volunteers
- 504 people
- Sponsor
- Biotronik SE & Co. KG
Aortic Valve Disease, Aortic Valve Stenosis
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT02221921
- Testing
- MicroPort's Transcatheter Aortic Valve and Delivery System
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Heart Disease
Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass
The study evaluates the efficacy of intravenous levosimendan treatment started during a coronary artery bypass operation to wean patients from a heart lung machine.
- Trial name
- NCT00130871
- Testing
- levosimendan
- Where
- 2 sites in Finland
- Volunteers
- 60 people
- Sponsor
- Orion Corporation, Orion Pharma
Heart Failure, Congestive
Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines
The purpose of this study is to assess the effect of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo on cardiac remodelling, estimated by change in left ventricular ejection fraction on radionuclide…
- Trial name
- NCT00240292
- Testing
- Rosuvastatin
- Where
- 13 sites in Australia
- Volunteers
- 160 people
- Sponsor
- AstraZeneca
Heart Failure, Cardiac Failure
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.
- Conditions
- Heart Failure, Cardiac Failure, Congestive Heart Failure, Heart Failure, Left-sided
- Trial name
- NCT02205411
- Testing
- HeartAssist 5® VAD System, Control VAD
- Where
- 14 sites in United States
- Volunteers
- 17 people
- Sponsor
- ReliantHeart Inc.
Heart Failure
Attain Stability™ Quad Clinical Study
The purpose of this clinical study is to evaluate the safety and efficacy of the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead (Model 4798).
- Trial name
- NCT03099655
- Testing
- Attain Stability Quad Left Ventricular Pacing Lead
- Where
- 50 sites in United States, Canada and 8 more
- Volunteers
- 471 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Disease
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve…
- Trial name
- CENTERA-1 (NCT01808274)
- Testing
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 34 people
- Sponsor
- Edwards Lifesciences
Cardiogenic Shock
Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock
This study is a prospective, multicenter, single-arm clinical trial conducted in China to evaluate the efficacy and safety of a novel left ventricular assist device, SynFlow Duro system, manufactured by ForQaly Medical in the…
- Trial name
- COURAGE (NCT07560085)
- Testing
- SynFlow Duro
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- ForQaly Medical (Shanghai) Co., Ltd
Severe Aortic Stenosis, Aortic Regurgitation
Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or…
- Trial name
- TAVI (NCT03788590)
- Testing
- Jenscare TAVI
- Volunteers
- 133 people
- Sponsor
- Ningbo Jenscare Biotechnology Co., Ltd.
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve…
- Conditions
- Aortic Valve Regurgitation, Aortic Valve Disease Mixed, Aortic Insufficiency
- Trial name
- NCT07363473
- Testing
- J-Valve Transfemoral System
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Ventricular Tachycardia, Ventricular Fibrillation
DF4 Connector System Post-Approval Study
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT01638897
- Where
- 78 sites in United States, Canada and 1 more
- Volunteers
- 1,778 people
- Sponsor
- Medtronic
Sinus Bradycardia, Sinus Node Disease
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
- Conditions
- Sinus Bradycardia, Sinus Node Disease, Atrio-ventricular Block
- Trial name
- IES-ACap (NCT00832260)
- Volunteers
- 70 people
- Sponsor
- Abbott Medical Devices
Sustained VT
Cryoablation for Monomorphic Ventricular Tachycardia
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)
- Trial name
- FULCRUM-VT (NCT05675865)
- Testing
- cryoablation procedure
- Where
- 15 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Adagio Medical
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