Clinical trials: Atrium; Flutter
Atrial Fibrillation, Atrial Flutter
FREEZE-AFIB Post-Market Study
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
- Trial name
- NCT05089877
- Testing
- Surgical Ablation
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation or Flutter
Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent onset atrial…
- Trial name
- RESTORE SR (NCT02454283)
- Testing
- Vanoxerine HCl
- Where
- 16 sites in United States, Bulgaria and 3 more
- Volunteers
- 41 people
- Sponsor
- Laguna Pharmaceuticals, Inc.
Atrial Fibrillation, Atrial Flutter
iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology
Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly, is a major health problem. The long-term goal of this project is to use a personal, mobile heart monitor to help patients better…
- Trial name
- iHEART (NCT02731326)
- Testing
- AliveCor, Behavioral Altering Messaging
- Where
- United States
- Volunteers
- 264 people
- Sponsor
- Columbia University
Typical Atrial Flutter
Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)
The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse…
- Trial name
- NCT00984204
- Testing
- Therapy Cool Path Duo
- Where
- 22 sites in United States, Canada
- Volunteers
- 188 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Flutter
Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism and Thrombosis
- Trial name
- SAFE-VEIN (NCT04632641)
- Testing
- Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES, Figure 8 Suture - LARGE-BORE PROCEDURES
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Wake Forest University Health Sciences
Atrial Fibrillation, Atrial Flutter
Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation
The primary objective of the study is to reduce hospital admission and decrease time to disposition through establishing an effective treatment protocol for AF and Atrial Flutter in the Emergency Department of Spectrum Health…
- Trial name
- NCT05391893
- Testing
- Oral, Intravenous drug
- Where
- United States
- Volunteers
- 444 people
- Sponsor
- Corewell Health South
Atrial Flutter
Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
The purpose of this study is to demonstrate the advantage of using a gold alloy tip electrode over a platinum/iridium alloy tip electrode in ablation of the cavotricuspid isthmus in patients with atrial flutter.
- Trial name
- NCT00326001
- Testing
- Gold tip catheter, Platinum-iridium tip catheter
- Where
- 28 sites in Czechia, Germany and 1 more
- Volunteers
- 463 people
- Sponsor
- Biotronik SE & Co. KG
Paroxysmal Atrial Fibrillation
The FARAPULSE FARA-Freedom Trial
The Post-Market Clinical Follow-Up trial is a prospective, multi-center, open-label, single-arm clinical follow-up study designed to provide long-term safety feasibility, effectiveness and performance of the FARAPULSE Pulsed…
- Trial name
- FARA-Freedom (NCT05072964)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 13 sites in Belgium, Czechia and 4 more
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
Atrial Flutter, Ventricular Tachycardia
Clinical Study to Evaluate the Catheter Robotics Amigo for Performing Right-Sided Electrophysiology Mapping Studies
The purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP…
- Trial name
- NCT01139814
- Testing
- Amigo catheter robot
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 181 people
- Sponsor
- Catheter Robotics, Inc.
Atrial Fibrillation, Atrial Flutter
Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography
The presence of intracardiac thrombi and their propensity for systemic embolism is a major concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing cardioversion and ablation procedures.
- Trial name
- ICE-TEE (NCT02213666)
- Testing
- Intracardiac Imaging
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Elad Anter
Symptomatic Atrial Fibrillation, Atrial Flutter
Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm
Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or flutter of recent onset to normal sinus…
- Trial name
- COR-ART (NCT01691313)
- Testing
- Vanoxerine
- Where
- 6 sites in Israel, Russia
- Volunteers
- 104 people
- Sponsor
- Laguna Pharmaceuticals, 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.
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
Atrial Fibrillation, Atrial Flutter
Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart valve repair/replacement patients.
- Trial name
- NCT00953212
- Testing
- beta blockers, amiodarone, ascorbic acid
- Where
- United States
- Volunteers
- 304 people
- Sponsor
- MaineHealth
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 Fluttering
Ankle - Brachial Index Measurement in Atrial Fibrillation
Consecutive patients with atrial fibrillation will be admitted to the hospital for electrical cardioversion. Ankle brachial index will be measured three times with oscillometric method and three times with doppler method.
- Trial name
- AFABI (NCT02986282)
- Testing
- ABI measurement using both doppler and oscillometric method
- Volunteers
- 115 people
- Sponsor
- Medical University of Warsaw
Atrial Flutter
Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
- Trial name
- NCT00318565
- Testing
- RF energy delivery for treatment of Typical Atrial flutter
- Where
- 23 sites in United States
- Volunteers
- 291 people
- Sponsor
- Biosense Webster, Inc.
Atrial Fibrillation, Atrial Flutter
Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus
The purpose of this study is to compare standard manual and robotically controlled catheter ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter.
- Trial name
- Amigo-AFL (NCT02467179)
- Testing
- Amigo™ Robotic Catheter Manipulation, Manual Catheter Manipulation
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
Typical Atrial Flutter
Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of…
- Trial name
- FLEXION-AFL (NCT01408485)
- Testing
- Therapy™ Cool Flex™ Irrigated Ablation System
- Where
- 24 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Cardiac Arrhythmia
EnSite Precision Observational Study
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software…
- Trial name
- NCT03260244
- Testing
- cardiac mapping and radiofrequency ablation procedure
- Where
- 7 sites in United States
- Volunteers
- 1,065 people
- Sponsor
- Abbott Medical Devices