Clinical trials: Heart Rhythm Disorders
Tachycardia
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up
- Trial name
- ISIS-ICD (NCT01410552)
- Testing
- PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770
- Where
- 80 sites in United States, France and 5 more
- Volunteers
- 1,013 people
- Sponsor
- MicroPort CRM
Ventricular Tachycardia, Ischemic Cardiomyopathy
Contrast ICE for Myocardial Scar in VT Ablations
There is a high correlation between scar areas identified by contrast-enhanced ICE and scar areas identified by conventional electroanatomic mapping.
- Trial name
- NCT03212326
- Testing
- Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]
- Volunteers
- 24 people
- Sponsor
- Weill Medical College of Cornell University
Atrial Fibrillation, Arrhythmias, Cardiac
Prospective Elimination Of Distal Coronary Sinus-Left Atrial Connections for Atrial Fibrillation Ablation Trial
Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting millions of people in the US and around the world. Over the last 20 years, catheter based AF ablation has been widely adopted offering improved symptom…
- Trial name
- PRECAF (NCT03646643)
- Testing
- Standard Atrial fibrillation ablation, Coronary sinus to left atrium connection elimination
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Pennsylvania
Atrial Fibrillation
Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage
The investigators intend to determine if using Optison echocardiography contrast increases sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal echocardiography studies as opposed to standard…
- Trial name
- DOLOP (NCT01721447)
- Testing
- Optison echocardiography contrast agent
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Utah
Atrial Fibrillation, Atrial Flutter
A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation
To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).
- Trial name
- ATHENA (NCT00174785)
- Testing
- dronedarone (SR33589)
- Where
- 37 sites in United States, Argentina and 35 more
- Volunteers
- 4,628 people
- Sponsor
- Sanofi
Atrial Fibrillation
POLARx Cardiac Cryoablation System Study
This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.
- Trial name
- POLAR ICE (NCT04250714)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 19 sites in Belgium, Croatia and 5 more
- Volunteers
- 400 people
- Sponsor
- Boston Scientific Corporation
Pulmonary Embolism, Venous Thromboembolism
Implementing Prescriber-Pharmacist Collaborative Care for Evidence-based Anticoagulant Use
The researchers hypothesize that existing-prescription notifications directed to pharmacists are more likely to lead to a prescription change than existing-prescription notifications directed to prescribers.
- Conditions
- Pulmonary Embolism, Venous Thromboembolism, Atrial Fibrillation
- Trial name
- NCT05351749
- Testing
- New-prescription Alert, New-prescription Alert with referral option, Existing-prescription notification to prescriber
- Where
- United States
- Volunteers
- 306 people
- Sponsor
- University of Michigan
Ventricular Tachycardia, Atrial Fibrillation
Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation
The broad, long-term objective of this project is to evaluate the therapeutic value of vein of Marshall (VOM) ethanol infusion when added to catheter ablation of atrial fibrillation (AF).
- Trial name
- VOM-R01 (NCT01898221)
- Testing
- Ethanol, Ablation
- Where
- 12 sites in United States
- Volunteers
- 343 people
- Sponsor
- The Methodist Hospital Research Institute
Persistent Atrial Fibrillation
Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)
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 Cardiac Ablation System Plus is a…
- Trial name
- PersAFOne II (NCT05152966)
- Testing
- Ablation
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)
To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial…
- Trial name
- NCT02069119
- Testing
- OPC-108459
- Where
- Japan
- Volunteers
- 48 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Fibrillation, Atrial
Evaluation of Efficacy and Safety of Lovaza (Omega-3-Acid Ethyl Esters) in Recurrent, Symptomatic Atrial Fibrillation
The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.
- Trial name
- NCT00402363
- Testing
- omega-3-acid ethyl esters
- Where
- 178 sites in United States
- Volunteers
- 663 people
- Sponsor
- GlaxoSmithKline
Heart Failure, Right Bundle-Branch Block
Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)
Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis.
- Trial name
- PACE-RBBB (NCT01169493)
- Testing
- VVI-40, RV DDD-40, BiV DDD-40
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Duke University
Atrial Fibrillation
Topera C-FIRM Registry
This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial…
- Trial name
- NCT02407249
- Where
- 9 sites in Germany, Netherlands
- Volunteers
- 73 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence
The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved…
- Conditions
- Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension
- Trial name
- RDN+AF (NCT01907828)
- Testing
- Renal Artery Ablation, Cardiac Ablation
- Where
- 2 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Abbott Medical Devices
Heart Diseases, Arrhythmia
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter.
- Conditions
- Heart Diseases, Arrhythmia, Atrial Fibrillation
- Trial name
- Afib IDE (NCT00116428)
- Testing
- NAVISTAR® THERMOCOOL® Catheter, Antiarrhythmic drug
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 167 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation, Inflammation
Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF)
The purpose of this study is to test whether the drug, atorvastatin, will be able to reduce the rate of return of the abnormal beats after using cardioversion.
- Trial name
- NCT00252967
- Testing
- Atorvastatin
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Emory University
Death, Sudden, Cardiac, Ventricular Fibrillation
Automatic External Defibrillation Monitoring in Cardiac Arrest
We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted to the telemetry ward, all other treatments…
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Ventricular
- Trial name
- NCT00382928
- Testing
- Defibrillation of pulseless VT/VF by AECD
- Where
- United States
- Volunteers
- 192 people
- Sponsor
- Foundation for Atlanta Veterans Education and Research, Inc.
Ventricular Tachyarrhythmias
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system.
- Trial name
- Chronic II (NCT00853645)
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) System
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Boston Scientific Corporation
Sudden Cardiac Death, Bradycardia
REASSURE AV Registry
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
- Trial name
- REASSURE (NCT01074034)
- Testing
- AV Therapy Assessment-B301 investigational device
- Where
- 36 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Hemorrhage
Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa
This study is being conducted to collect data on the management of major bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.
- Trial name
- NCT02149303
- Testing
- Dabigatran 75 mg, Dabigatran 150 mg
- Where
- 5 sites in United States
- Volunteers
- 191 people
- Sponsor
- Boehringer Ingelheim