Clinical trials: Cardiac Rhythm Disorder
Atrial Fibrillation
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study.
- Trial name
- SELECT-AF (NCT00926783)
- Testing
- CFAE ablation
- Where
- 7 sites in United States, Australia and 1 more
- Volunteers
- 86 people
- Sponsor
- Biosense Webster, Inc.
Tachycardia
RIGHT: Rhythm ID Going Head-to-Head Trial
RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy of VITALITY 2 implantable cardioverter defibrillators (ICDs) using Rhythm ID™ versus selected Medtronic ICDs.
- Trial name
- NCT00148954
- Testing
- VITALITY 2 Implantable Cardioverter Defibrillator, Medtronic Implantable Cardioverter Defibrillator
- Where
- United States
- Volunteers
- 1,962 people
- Sponsor
- Boston Scientific Corporation
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
Atrial Fibrillation
The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis
The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly…
- Trial name
- NCT03026556
- Testing
- Dabigatran vs. Rivaroxaban, Dabigatran vs. Apixaban
- Where
- United States
- Volunteers
- 42,534 people
- Sponsor
- Boehringer Ingelheim
Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures
A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.
- Trial name
- REDO-FIRM (NCT02799043)
- Testing
- Standard PVI, FIRM-Guided Procedure and PVI
- Where
- 24 sites in United States, Belgium and 2 more
- Volunteers
- 269 people
- Sponsor
- Abbott Medical Devices
Ventricular Tachycardia
Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia
Imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (PET/CT), after a special dye is injected.
- Trial name
- NCT02962076
- Testing
- [C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Khaled Awad, MD
Atrial Fibrillation
Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)
1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be…
- Trial name
- NCT02240667
- Testing
- Dabigatran etexilate, Vitamin K antagonists
- Where
- Germany
- Volunteers
- 1,506 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
A prospective non-interventional single-centre study aimed to evaluate actual adherence of AF patients using the validated adherence Scale.
- Trial name
- ANTEY (NCT03790917)
- Where
- Russia
- Volunteers
- 201 people
- Sponsor
- National Research Center for Preventive Medicine
Atrial Fibrillation
The Home INR Study
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers…
- Trial name
- THINRS (NCT00032591)
- Testing
- Weekly patient self-testing of prothrombin time, High quality anticoagulation management (HQACM) with conventional monthly testing
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 2,922 people
- Sponsor
- US Department of Veterans Affairs
Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI…
- Trial name
- NCT01576016
- Testing
- Accent MRI system (lead safety), Accent MRI system (with MRI scan)
- Where
- 70 sites in United States, Australia and 3 more
- Volunteers
- 950 people
- Sponsor
- Abbott Medical Devices
Bradycardia
INGEVITY™ Observational Trial
The objectives of this registry are to 1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events 2.
- Trial name
- GENTLE (NCT02166606)
- Testing
- ImageReady MR Conditional Pacing System Implant
- Where
- 60 sites in Austria, Belgium and 11 more
- Volunteers
- 1,184 people
- Sponsor
- Boston Scientific Corporation
Congenital Heart Disease, Bradycardia Sinus
Specialized Pacing for Patients With Congenital Heart Disease
The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing…
- Trial name
- NCT03361189
- Testing
- Closed loop stimulation, Standard rate response
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, Los Angeles
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation.
- Trial name
- ADVANCE-CRTD (NCT00147290)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 526 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period.
- Trial name
- NCT03187197
- Testing
- Pradaxa®
- Where
- 24 sites in Taiwan
- Volunteers
- 1,315 people
- Sponsor
- Boehringer Ingelheim
Anticoagulants, Atrial Fibrillation
Improving Anticoagulation Control in VISN 1
Over 100,000 VHA patients receive anticoagulants (blood thinners) each year to prevent blood clots (including strokes). Too much anticoagulation increases the risk of serious or even fatal bleeding, and too little anticoagulation…
- Conditions
- Anticoagulants, Atrial Fibrillation, Venous Thromboembolism
- Trial name
- NCT01653405
- Testing
- Multifaceted behavioral intervention
- Where
- United States
- Volunteers
- 1,260,576 people
- Sponsor
- VA Office of Research and Development
Atrial Fibrillation
Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF)…
- Trial name
- NCT02348723
- Testing
- Warfarin, Dabigatran Etexilate 150mg
- Where
- 87 sites in United States, Belgium and 9 more
- Volunteers
- 678 people
- Sponsor
- Boehringer Ingelheim
Arrhythmias, Cardiac
Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients
Hemodialysis patients have a rate of fatal arrhythmias that is 40 times greater than the general population, but the causes and types of fatal arrhythmias they experience is unclear.
- Trial name
- CARE-ESRD (NCT00932659)
- Testing
- continuous cardiac monitoring device (REVEAL, Medtronic)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Duke University
Atrial Fibrillation New Onset, Hemorrhage
Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation
The aim of this study is to evaluate the prophylactic effects of Ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at Staten Island University hospital.
- Conditions
- Atrial Fibrillation New Onset, Hemorrhage, Prolonged QTc Interval, Ventricular Tachycardia
- Trial name
- NCT01590979
- Testing
- Ranolazine
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Northwell Health
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
The purpose of this study is to assess the performance and safety of using the investigational catheter.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- NCT05970120
- Testing
- NUVISION NAV Ultrasound Catheter
- Where
- 3 sites in Croatia, Israel and 1 more
- Volunteers
- 30 people
- Sponsor
- Biosense Webster, Inc.
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