Clinical trials: Block, Heart
Heart Failure, Chronic Heart Failure
Wearable Tissue Oximetry During Arm Cuff Occlusion, Walking, and Standing Tests in Outpatients With Chronic Heart Failure
This prospective, single-center, observational pilot study evaluated an investigational wearable tissue oximeter (NIRSense Argus Oximetry System, also called Envello Core) in adult outpatients with chronic heart failure in New…
- Trial name
- NCT07874386
- Testing
- Argus Oximetry System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- NIRSense Inc.
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Leadless Pacemaker, Bradycardia
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according…
- Conditions
- Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
- Trial name
- BIO-LivIQ (NCT07118358)
- Testing
- LivIQ Leadless Pacemaker System
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 325 people
- Sponsor
- Biotronik, Inc.
Aortic Valve Stenosis
The Leaflex™ Early Feasibility Study
A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.
- Trial name
- NCT04636073
- Testing
- Leaflex™ Performer
- Sponsor
- Pi-cardia
Atrioventricular Block, Heart Diseases
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- BLOCK HF (NCT00267098)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 54 sites in United States, Canada
- Volunteers
- 918 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacemaker, Arrythmia
Aveir VR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05270499
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 3,427 people
- Sponsor
- Abbott Medical Devices
Percutaneous Coronary Intervention, Coronary Artery Disease
Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System
Insight Lifetech Intravascular Ultrasound Diagnostic System (referred to as Insight Lifetech IVUS system below),is a new high-speed and high-resolution device for clearly defining vessel architecture and plaque morphology…
- Conditions
- Percutaneous Coronary Intervention, Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Left Main Coronary Artery Disease
- Trial name
- NEW-IVUS (NCT04739657)
- Testing
- Insight Lifetech IVUS System, Boston Scientific IVUS System
- Where
- 5 sites in China
- Volunteers
- 130 people
- Sponsor
- Insight Lifetech Co., Ltd.
Left Ventricular Dysfunction
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
This study will be done in patients who require the implantation of a cardiac pacemaker (an electronic device that controls the heartbeat) for complete heart block (a heart rhythm abnormality resulting in a slow heart beat).
- Trial name
- PROTECT-PACE (NCT00461734)
- Testing
- RV lead placement site
- Where
- 18 sites in Australia, New Zealand and 1 more
- Volunteers
- 248 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Coronary Disease, Coronary Artery Disease
To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB UK (NCT01977534)
- Testing
- Absorb BVS
- Where
- 24 sites in United Kingdom
- Volunteers
- 1,005 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been…
- Trial name
- NCT07827105
- Testing
- AK-AVS
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- AccurKardia, Inc.
Coronary Disease, Coronary Artery Disease
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx drug-eluting stent in patients with blockage of native coronary arteries.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ZoMaxx™ II (NCT00140101)
- Testing
- ZoMaxx™ Drug-Eluting Coronary Stent System, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 92 sites in United States, Australia and 2 more
- Volunteers
- 1,099 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Vivio AS (Aortic Stenosis) Algorithm Optimization Study
Optimize a candidate software algorithm using data collected with the Vivio system for use as an aid in the identification of heart sounds associated with severe aortic stenosis
- Trial name
- NCT04068402
- Testing
- Vivio System
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ventric Health, LLC
Aortic Valve Stenosis
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are…
- Trial name
- NCT05864456
- Testing
- Prizvalve Pro™ transcatheter aortic valve system
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Coronary Disease, Coronary Artery Disease
ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation
Prospective, open-labeled First in Man Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x 18 mm BVS EECSS containing 98 microgramme per cm²…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB A (NCT00300131)
- Testing
- Bioabsorbable Everolimus Eluting Coronary Stent
- Where
- 4 sites in Denmark, Netherlands and 2 more
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Cardiovascular Disease (CVD), Heart Failure
Study of the Progression of Chronic Cardiovascular Conditions
This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.
- Conditions
- Cardiovascular Disease (CVD), Heart Failure, Aortic Stenosis, Aortic Stenosis Disease
- Trial name
- OCORO (NCT07420907)
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Prolaio
Sinus Node Dysfunction, Brady Tachy Syndrome
Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
- Trial name
- NCT01170611
- Testing
- PACEMAKER SYMPHONY 2550
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 400 people
- Sponsor
- LivaNova
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Israel Satellite Registry
BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus Type 1 or 2
- Trial name
- NCT01895712
- Where
- 6 sites in Israel
- Volunteers
- 120 people
- Sponsor
- BIOTRONIK Israel
Aortic Valve Stenosis
REST Study: Left Ventricular Regression European Study
The purpose of this study is to obtain data regarding the left ventricular mass (LVM) regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing LVM regression measured with magnetic resonance…
- Trial name
- NCT00256165
- Testing
- Tissue valve
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
BIOFLOW III Satellite-ELADIS Orsiro Stent System
This registry is a clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- NCT02029092
- Where
- 14 sites in Spain
- Volunteers
- 404 people
- Sponsor
- C.E.M. Biotronik, S.A.