Clinical trials: Arrhythmia Atrial
Left Atrial Appendage Exclusion
AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.
- Trial name
- EXCLUDE (NCT00779857)
- Testing
- AtriCure LAA Exclusion System
- Where
- 7 sites in United States
- Volunteers
- 70 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Corticosteroid Pulse After Ablation
Radiofrequency ablation is an effective treatment for atrial fibrillation. However, about 20% of the time the atrial fibrillation recurs.
- Trial name
- SAAB (NCT00807586)
- Testing
- Solumedrol
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- Minneapolis Heart Institute Foundation
Atrial Fibrillation
Esophageal Cooling in Radiofrequency Cardiac Ablation
This pilot study evaluates the addition of the EnsoETM esophageal cooling device to the radiofrequency (RF) ablation procedure in the treatment of atrial fibrillation in adults.
- Trial name
- NCT03481023
- Testing
- EnsoETM, Conventional Care
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Riverside Medical Center
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation
This clinical trial is being done to determine if metformin, a drug which is normally used in diabetes, can reduce atrial fibrillation in patients who are having an ablation for atrial fibrillation (AF).
- Trial name
- NCT04625946
- Testing
- Metformin, Recommendations for lifestyle modification., AliveCor
- Where
- United States
- Volunteers
- 117 people
- Sponsor
- University of Michigan
Paroxysmal Atrial Fibrillation
LSI (Lesion Index) Workflow Observational Study
This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter…
- Trial name
- NCT03906461
- Testing
- Radiofrequency Ablation
- Where
- 9 sites in United States, Germany and 3 more
- Volunteers
- 143 people
- Sponsor
- Abbott Medical Devices
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.
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