Clinical trials: Cardiac Rhythm Disorder
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Automated Assessment of PVI Using a Novel EP Recording System
A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.
- Trial name
- PVISION (NCT05043883)
- Testing
- CathVision Cube® system
- Where
- 4 sites in Belgium, France
- Volunteers
- 101 people
- Sponsor
- CathVision ApS
Acute Coronary Syndrome
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death…
- Trial name
- AEGIS-II (NCT03473223)
- Testing
- Apolipoprotein A-I [human] (apoA-I)
- Where
- 903 sites in United States, Argentina and 47 more
- Volunteers
- 18,226 people
- Sponsor
- CSL Behring
Atrial Fibrillation, Heart Valve Diseases
Prolongation of the Interval Between Monitoring of Warfarin in Stable Patients
Patients with mechanical heart valve prosthesis or with irregular beat (atrial fibrillation) have a high risk of blood clot formation. Such clots can result in a stroke.
- Conditions
- Atrial Fibrillation, Heart Valve Diseases, Venous Thrombosis
- Trial name
- NCT00356759
- Where
- Canada
- Volunteers
- 250 people
- Sponsor
- Hamilton Health Sciences Corporation
Atrial Fibrillation
Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation
This study includes treating patients with atrial fibrillation (AF) with Dabigatran, an anti-coagulant for a period of one year to see if there are any significant changes in the degree of left atrial structural remodeling in…
- Trial name
- DEPAF (NCT01546883)
- Testing
- Dabigatran etexilate (Pradaxa)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of Utah
Heart Failure, Left Bundle-Branch Block
Mid-Q Response Study
The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study.
- Conditions
- Heart Failure, Left Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure NYHA Class II
- Trial name
- NCT04180696
- Testing
- aCRT ON, aCRT OFF
- Where
- 61 sites in Brunei, China and 8 more
- Volunteers
- 177 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmia
Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
The purpose of this study is to determine if atorvastatin (Lipitor) reduces the occurence of abnormal heart rhythm (atrial arrhythmia) following non cardiac thoracic surgery.
- Trial name
- NCT00756886
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Persistent Atrial Fibrillation
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation…
- Trial name
- ADVANTAGE AF (NCT05443594)
- Testing
- Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 669 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Tachycardia, Supraventricular
TOCCATA - Touch+™ for Catheter Ablation
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation.
- Trial name
- TOCCATA (NCT01223469)
- Testing
- Contact force assisted irrigated RF ablation
- Volunteers
- 77 people
- Sponsor
- Abbott Medical Devices
Hyperkalemia
POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
This study assesses serum potassium and cardiac rhythm trends in subjects with end stage renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days.
- Trial name
- PORTEND (NCT02609841)
- Testing
- Cardiac rhythm remote monitoring system
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- ZS Pharma, Inc.
Persistent Atrial Fibrillation
The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation
The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Pulsed Field Ablation System Plus-PersAF…
- Trial name
- CS1543 (NCT05272852)
- Testing
- FARAPULSE™ Pulsed Field Ablation System Plus
- Where
- 2 sites in Czechia
- Volunteers
- 80 people
- Sponsor
- Boston Scientific Corporation
Septic Shock, Sepsis
Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients
Septic shock is a condition that is marked by severe infection causing hypotension requiring vasopressors to maintain adequate perfusion to vital organs.
- Conditions
- Septic Shock, Sepsis, Shock, Tachycardia
- Trial name
- NCT02203630
- Testing
- Phenylephrine, Norepinephrine
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Vanderbilt University Medical Center
Atrial Fibrillation
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
- Trial name
- STELLAR (NCT03683030)
- Testing
- Multi-Electrode RF Balloon Catheter
- Where
- 41 sites in United States, China and 1 more
- Volunteers
- 397 people
- Sponsor
- Biosense Webster, Inc.
Myocardial Infarction, Ventricular Dysfunction
Vest Prevention of Early Sudden Death Trial and VEST Registry
This study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias.
- Conditions
- Myocardial Infarction, Ventricular Dysfunction, Sudden Death, Ventricular Tachycardia
- Trial name
- VEST (NCT01446965)
- Testing
- wearable defibrillator
- Where
- 71 sites in United States, Germany and 1 more
- Volunteers
- 2,348 people
- Sponsor
- University of California, San Francisco
Paroxysmal Atrial Fibrillation
The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation
This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon…
- Trial name
- ADVENT (NCT04612244)
- Testing
- FARAPULSE Pulsed Field Ablation System, RadioFrequency and Cryoballoon Ablation
- Where
- 34 sites in United States
- Volunteers
- 706 people
- Sponsor
- Boston Scientific Corporation
Cardiovascular Diseases, Atrial Fibrillation
A Digital Flu Intervention for People With Cardiovascular Conditions
A 6-month prospective, digital randomized controlled trial targeting approximately 49,000 individuals to evaluate the effectiveness of an influenza vaccination intervention during influenza season for people with cardiovascular…
- Conditions
- Cardiovascular Diseases, Atrial Fibrillation, Abnormal Heart Rhythms, Cardiac Arrest
- Trial name
- CardioFlu (NCT04584645)
- Testing
- Targeted digital intervention
- Where
- United States
- Volunteers
- 49,138 people
- Sponsor
- Evidation Health
Atrial Fibrillation
Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation
The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients.
- Trial name
- NCT02433366
- Where
- 161 sites in Bulgaria, Czechia and 6 more
- Volunteers
- 1,213 people
- Sponsor
- Boehringer Ingelheim
Reversal of Neuromuscular Blockade
Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)
The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of…
- Trial name
- NCT03346057
- Testing
- Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, Sugammadex 16 mg/kg
- Where
- 30 sites in United States, Austria and 2 more
- Volunteers
- 344 people
- Sponsor
- Merck Sharp & Dohme LLC
Atrial Fibrillation, Congestive Heart Failure
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing…
- Trial name
- AVAIL (NCT00356057)
- Testing
- Protos DR/CLS and Stratos LV CRT pacemakers
- Where
- 10 sites in United States
- Volunteers
- 153 people
- Sponsor
- Biotronik, Inc.
Cardiac Arrhythmia, Atrial Fibrillation
Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias
Atrial fibrillation (AF) is the most common arrhythmia (irregular heart rhythm), affecting 1-2 million people in the UK. AF significantly increases the risk of an AF-related stroke, heart failure and dementia.
- Trial name
- WEAR-TECH ECG (NCT05298553)
- Testing
- Group A, Group B
- Where
- 3 sites in United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Oxford University Hospitals NHS Trust
Ventricular Tachycardia (VT)
Pan-Asia United States PrEvention of Sudden Cardiac Death Catheter Ablation Trial
The current standard of care for ventricular tachycardia (VT) includes the use of medicine called anti-arrhythmic drugs (AADs) and Implantable Cardioverter Defibrillator (ICD) therapy.
- Trial name
- PAUSE-SCD (NCT02848781)
- Testing
- Implantable Cardioverter Defibrillator (ICD), Catheter Ablation
- Where
- 12 sites in United States, China and 3 more
- Volunteers
- 180 people
- Sponsor
- University of Arizona