Clinical trials: Cardiac Rhythm Disturbance
Paroxysmal Atrial Fibrillation
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial…
- Trial name
- FARA-Free (NCT04474054)
- Testing
- Catheter ablation to treat paroxysmal atrial fibrillation
- Where
- Croatia
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
HD Mapping of Atrial Fibrillation in Asia Pacific
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop…
- Trial name
- NCT04022954
- Testing
- Catheter ablation
- Where
- 15 sites in China, Hong Kong and 3 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Evaluation of the CIRCA Monitoring System in Prevention of Esophageal Lesions Following RFCA
The purpose of this study is to determine if the use of Circa™ temperature monitoring system during ablation procedures will reduce the risk of esophageal lesions or damage.
- Trial name
- CIRCA-EGD (NCT02467166)
- Testing
- Circa™ Probe
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
Neonates
NICU-TECH RM9L-RS Probe ME Feasibility Study
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself.
- Trial name
- NCT01181596
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- GE Healthcare
Atrial Fibrillation
First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)
The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not…
- Trial name
- RAAFT (NCT00392054)
- Testing
- Pulmonary Vein Isolation performed by Catheter Ablation, Conventional Antiarrhythmic Drug Therapy
- Where
- 16 sites in United States, Canada and 3 more
- Volunteers
- 127 people
- Sponsor
- Population Health Research Institute
Tachyarrhythmias, Syncope
Study of New Implantable Loop Recorder
The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).
- Trial name
- NCT00746564
- Testing
- SJM Confirm
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin.
- Trial name
- ENSURE-AF (NCT02072434)
- Testing
- Edoxaban, Warfarin, Enoxaparin
- Where
- 228 sites in United States, Austria and 17 more
- Volunteers
- 2,199 people
- Sponsor
- Daiichi Sankyo
Atrial Fibrillation, Ischemic Stroke
AMPLATZER Cardiac Plug Clinical Trial
The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to…
- Conditions
- Atrial Fibrillation, Ischemic Stroke, Peripheral Thromboembolism
- Trial name
- NCT01118299
- Testing
- AMPLATZER Cardiac Plug
- Where
- 18 sites in United States
- Volunteers
- 97 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)
The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.
- Trial name
- NCT02944968
- Testing
- THERMOCOOL SMARTTOUCH® SF-5D catheter
- Volunteers
- 51 people
- Sponsor
- Biosense Webster, Inc.
Bradycardia, Sinus Node Dysfunction
ImageReady(TM) MR Conditional Pacing System Clinical Study
The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with…
- Trial name
- SAMURAI (NCT01781078)
- Testing
- MRI, ImageReady System implant
- Where
- 41 sites in United States, Australia and 5 more
- Volunteers
- 363 people
- Sponsor
- Boston Scientific Corporation
Arrhythmogenic Right Ventricular Cardiomyopathy
Pilot Randomized Trial With Flecainide in ARVC Patients
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited arrhythmia disorder with high risk of ventricular tachycardia or fibrillation, and implantable cardioverter defibrillator remains as therapy of choice.
- Trial name
- NCT03685149
- Testing
- Flecainide Pill
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- University of Rochester
Atrial Fibrillation
Renin-angiotensin-aldosterone System (RAAS), Inflammation, and Post-Operative Atrial Fibrillation (AF)
Atrial fibrillation (AF) is the most prevalent, sustained type of irregular heartbeat and affects over 2 million Americans. Post-operative AF, which leads to significant morbidity and a prolonged hospital stay, complicates 20% to…
- Trial name
- NCT00141778
- Testing
- Ramipril, Spironolactone
- Where
- United States
- Volunteers
- 455 people
- Sponsor
- Vanderbilt University
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial…
- Trial name
- ABLATE-PAS (NCT01694563)
- Testing
- Synergy Ablation System
- Where
- 49 sites in United States
- Volunteers
- 365 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of…
- Trial name
- Omny-IRE (NCT05971693)
- Testing
- OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
- Where
- 13 sites in Belgium, Canada and 6 more
- Volunteers
- 188 people
- Sponsor
- Biosense Webster, Inc.
Persistent Atrial Fibrillation
AF Substrate Mapping and Guided Ablation
In this study, the investigators aim to identify and characterize, by means of an EnSite Velocity Research Software, the electrophysiological characteristics of substrates that sustain AF in patients with persistent AF and to…
- Trial name
- NCT02571218
- Testing
- Substrate+mCPVA, mCPVA
- Where
- Italy
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram…
- Trial name
- NCT03082963
- Testing
- Electrogram Morphology Mapping (EMR)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Jeffrey Goldberger
Sleep Disordered Breathing, Sleep Apnea
Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation
Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with prevalence expected to rise significantly the coming decades.
- Conditions
- Sleep Disordered Breathing, Sleep Apnea, Paroxysmal Atrial Fibrillation
- Trial name
- NCT02727192
- Testing
- PAP (CPAP or ASV)
- Where
- Norway
- Volunteers
- 109 people
- Sponsor
- Oslo University Hospital
Atrial Fibrillation
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
- Trial name
- ABLATE (NCT00560885)
- Testing
- AtriCure Bipolar System
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- AtriCure, Inc.
Acute Kidney Injury, Fluid Overload
Restrictive Versus Liberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury
Critically ill patients with acute kidney injury and fluid overload who are frequently treated by fluid removal during dialysis are at an increased risk of complications and death.
- Conditions
- Acute Kidney Injury, Fluid Overload, Hypotension, Dialysis; Complications
- Trial name
- RELIEVE-AKI (NCT05306964)
- Testing
- Restrictive UFnet Rate Strategy, Liberal UFnet Rate Strategy
- Where
- 2 sites in United States
- Volunteers
- 99 people
- Sponsor
- University of Pittsburgh
Wound, Cardiac Arrhythmia
ZIPS Study - Zip Incision aPproximation vs. Suture
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.
- Trial name
- ZIPS (NCT02213510)
- Testing
- Zip Surgical Skin Closure Device, Standard Suture Closure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego