Clinical trials: Heart Rhythm Disorders
Atrial Fibrillation
Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures
Left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure.
- Trial name
- NCT04063761
- Testing
- esophageal cooling device (Attune Medical, Chicago, IL)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Atrial Fibrillation
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric sensing compared with customary electrical isolation tests and Adenosine infusion at the end of the procedure.
- Trial name
- DURABLE-I (NCT02878213)
- Testing
- D700 System
- Where
- Russia
- Volunteers
- 39 people
- Sponsor
- EPD Solutions, A Philips Company
Bradycardia
P3: Pacemaker Patient Profiling Study
The P3 Study is a United States post market study to gather data on clinical status, primary indications, device therapy choices, clinical management and outcomes for patients with implantable pacemakers.
- Trial name
- NCT00294060
- Where
- 83 sites in United States
- Volunteers
- 2,013 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation…
- Trial name
- Staged DEEP (NCT01661205)
- Testing
- Ablation procedure staged catheter ablation
- Where
- 6 sites in United States, Belgium and 1 more
- Volunteers
- 30 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)
This non-interventional prospective study is a post-authorization safety study (PASS) of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically…
- Trial name
- NCT01370629
- Testing
- Vernakalant
- Where
- 6 sites in Austria, Denmark and 4 more
- Volunteers
- 2,015 people
- Sponsor
- Correvio International Sarl
Atrial Fibrillation
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
This study will evaluate the use of a robotic device that is remotely controlled to maneuver a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation procedures.
- Trial name
- VERSATILE (NCT01656772)
- Testing
- Vdrive Lasso navigation, Manual Lasso navigation
- Where
- 5 sites in United States, Belgium and 1 more
- Volunteers
- 120 people
- Sponsor
- Stereotaxis
Heart Failure, Tachycardia, Ventricular
Optisure Lead Post Approval Study
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.
- Trial name
- NCT02235545
- Testing
- St. Jude Medical Optisure Lead
- Where
- 60 sites in United States, Belgium and 5 more
- Volunteers
- 1,735 people
- Sponsor
- Abbott Medical Devices
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
Arrhythmias, Cardiac
Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.
- Trial name
- SAFE-DX-Home (NCT04869527)
- Testing
- BIOTRONIK ICDs with DX Technology
- Where
- 2 sites in Brazil
- Volunteers
- 56 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
Atrial Fibrillation Progression Trial
The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in…
- Trial name
- ATTEST (NCT01570361)
- Testing
- Catheter Ablation, Drug Treatment
- Volunteers
- 255 people
- Sponsor
- Biosense Webster, Inc.
Transient Ischemic Attack, Stroke
Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation
The purpose of this study is to evaluate if Apixaban will decrease the complication of having another stroke for people who have atrial fibrillation if initiated earlier than standard of care.
- Conditions
- Transient Ischemic Attack, Stroke, Atrial Fibrillation
- Trial name
- AREST (NCT02283294)
- Testing
- Apixaban, Warfarin
- Where
- 5 sites in United States
- Volunteers
- 91 people
- Sponsor
- University of South Florida
Cardiac Rhythm Disorder, Bradycardia
Patient Preferences for Leadless Pacemakers
Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers
- Conditions
- Cardiac Rhythm Disorder, Bradycardia, Cardiac Pacemaker Artificial
- Trial name
- NCT05327101
- Testing
- Patient Preference Survey
- Where
- 11 sites in United States
- Volunteers
- 117 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Transcutaneous (Tragus) Vagal Nerve Stimulation for Post-op Afib
Patients undergoing cardiac surgery are at high risk of developing atrial fibrillation (AF), with estimated rates of 30-50% and occurs at approximately 2-4 days after surgery.
- Trial name
- STOP_AF (NCT04514757)
- Testing
- active tVNS
- Where
- 2 sites in United States
- Volunteers
- 77 people
- Sponsor
- University of California, Los Angeles
Arrhythmias, Cardiac
Reveal In-Office Implants
The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional…
- Trial name
- NCT01168427
- Testing
- Reveal® DX or Reveal® XT Insertable Cardiac Monitor
- Where
- 9 sites in United States
- Volunteers
- 66 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmia
Reveal LINQ™ In-Office 2 (RIO2) Study International
The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".
- Trial name
- RIO2 (NCT02412488)
- Testing
- Out of cathlab insertion
- Volunteers
- 191 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation
Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.
- Trial name
- IRASE-AF (NCT01056328)
- Testing
- SJM Irrigated Cardiac Ablation System, FDA approved Open Irrigated RF Ablation System
- Where
- 30 sites in United States, Canada and 1 more
- Volunteers
- 324 people
- Sponsor
- Abbott Medical Devices
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
Prolonged QT Interval in EKG and Sudden Death
Influence of Progesterone Administration on Drug-Induced QT Interval Lengthening
Female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia (irregular heartbeat) known as torsades de pointes (TdP), which is associated with prolongation of the corrected QT (QTc) interval on the…
- Trial name
- NCT01929083
- Testing
- Progesterone, Ibutilide
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Indiana University
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
Atrial Fibrillation
Adherence to New Oral Anticoagulation Therapy in Turkey
This study will compose a national database of drug adherence and investigate the factors that affect drug adherence in patients taking new oral anticoagulation therapy in Turkish Population.
- Trial name
- NOAC-TR (NCT02480920)
- Where
- Turkey (Türkiye)
- Volunteers
- 2,738 people
- Sponsor
- Cardiovascular Academy Society, Turkey