Clinical trials: Heart Rhythm Disorders
Persistent Atrial Fibrillation
Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF
The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate persistent atrial fibrillation (PsAF) to either…
- Trial name
- RAPID-AF (NCT03064451)
- Testing
- cartofinder guided ablation followed by PVI
- Where
- 7 sites in Belgium, Canada and 2 more
- Volunteers
- 60 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
Arrhythmia, Bradycardia
CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse
This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.
- Trial name
- NCT00275769
- Testing
- Pacemaker
- Where
- 57 sites in United States, Canada
- Volunteers
- 860 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation
Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial…
- Trial name
- NCT01122173
- Testing
- Ablation
- Where
- 13 sites in United States, Czechia and 3 more
- Volunteers
- 150 people
- Sponsor
- Hansen Medical
Ventricular Tachycardia
Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia
This is a prospective, non-randomized, multi-center clinical case series evaluating the outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases.
- Trial name
- STOP-VT (NCT00851279)
- Testing
- Magnetic irrigated ablation catheter
- Where
- 4 sites in United States, Czechia and 1 more
- Volunteers
- 53 people
- Sponsor
- Stereotaxis
Paroxysmal Atrial Fibrillation
FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial…
- Trial name
- FIRMAP-AF (NCT02703454)
- Testing
- FIRM-guided RF ablation, Conventional RF ablation
- Where
- Germany
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation
Primary Objective: Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation.
- Trial name
- ARTEMIS AF LT (NCT01199081)
- Testing
- Dronedarone
- Where
- 40 sites in Colombia, Czechia and 5 more
- Volunteers
- 154 people
- Sponsor
- Sanofi
Sick Sinus Syndrome, Heart Failure, Congestive
SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction
SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outcome of time to development of persistent…
- Conditions
- Sick Sinus Syndrome, Heart Failure, Congestive, Atrial Fibrillation, Bradycardia
- Trial name
- SAVEPACe (NCT00284830)
- Testing
- Implantable Pulse Generators
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,070 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Paroxysmal Atrial Fibrillation (PAF)
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
- Trial name
- STOP AF PAS (NCT01456949)
- Testing
- Medtronic Arctic Front® Cardiac CryoAblation System
- Where
- 39 sites in United States, Canada
- Volunteers
- 402 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation (AF), Persistent Atrial Fibrillation
Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)
Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia.
- Conditions
- Atrial Fibrillation (AF), Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation (PAF)
- Trial name
- Conquer-AF (NCT07298473)
- Testing
- Sphere-9 Catheter Ablation
- Where
- 30 sites in United States, Australia and 4 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation
The purpose of Part 1 of this study is to determine the maximally tolerated dose of OPC-108459 in patients with paroxysmal and persistent atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- Trial name
- CADENCE 215 (NCT01483183)
- Testing
- OPC-108459
- Where
- 25 sites in United States, Germany and 4 more
- Volunteers
- 40 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Persistent Atrial Fibrillation
Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the…
- Trial name
- NCT03650556
- Testing
- TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
- Where
- 22 sites in United States, Australia
- Volunteers
- 224 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Flutter
DeteCtiON and Stroke PreventIon by MoDEl ScRreenING for Atrial Fibrillation
Atrial fibrillation (AF) is the most common clinical arrhythmia and the prevalence increases with age. AF increases the risk of ischaemic stroke fivefold and accounts for almost one-third of all strokes.
- Trial name
- CONSIDERING-AF (NCT05838781)
- Testing
- Risk prediction model, 14-days continuous ECG monitoring
- Where
- 2 sites in Sweden
- Volunteers
- 2,112 people
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation, Atrial Inflammation
Inflammation, Fibrosis and Risk of Recurrence After Atrial Fibrillation Ablation
FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful ablation of atrial fibrillation.
- Trial name
- FIBRO-RISK (NCT03757741)
- Testing
- Cardiac imaging tests, Venous blood samle collection
- Where
- Romania
- Volunteers
- 100 people
- Sponsor
- Cardio Med Medical Center
Atrial Fibrillation, Atrial Flutter
Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Venous Thromboembolic Disease, Myocardial Infarction
- Trial name
- EmbraceAC (NCT00691470)
- Testing
- ATI-5923, Coumadin (warfarin)
- Where
- 41 sites in United States
- Volunteers
- 600 people
- Sponsor
- ARYx Therapeutics
Atrial Fibrillation, Atrial Flutter
Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter
The primary purpose of this study is to optimize drug exposure in the target population.
- Trial name
- NCT01229254
- Testing
- Amiodarone, Betrixaban 60 mg, Betrixaban 90 mg
- Volunteers
- 189 people
- Sponsor
- Portola Pharmaceuticals
Congestive Heart Failure
Monitoring of Arrhythmias and HRV in Patients With Heart Failure Treated With the CRT Pacemaker Renewal TR2
The objective of this study is to evaluate the prevalence of sustained ventricular and supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular resynchronization therapy (CRT) device
- Trial name
- NCT00180531
- Testing
- Renewal TR2
- Where
- 10 sites in France
- Volunteers
- 500 people
- Sponsor
- Guidant Corporation
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
A Study to Compare the Effect on Heart Rhythm of 3 Days of GSK189075, Placebo, or Moxifloxacin in Healthy Adults
This study assesses for change in heart rhythm of healthy volunteers taking GSK189075 for 3 days at a normal dose and a higher than normal dose compared to placebo or to a single dose of moxifloxacin.
- Trial name
- NCT00532610
- Testing
- GSK189075
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Ventricular Tachycardia, Ventricular Fibrillation
DF4 Master Study (Safety and Efficacy Study)
The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT01790841
- Testing
- Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
- Where
- Germany
- Volunteers
- 240 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
Evaluation of Weekly Idrabiotaparinux Sodium Versus Oral Adjusted-dose Warfarin to Prevent Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation
The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international…
- Trial name
- BOREALIS-AF (NCT00580216)
- Testing
- Idrabiotaparinux sodium, Warfarin, Avidin
- Where
- 538 sites in United States, Argentina and 46 more
- Volunteers
- 3,773 people
- Sponsor
- Sanofi