Clinical trials: Cardiac Rhythm Disorder
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
Supraventricular Tachycardia
Dexmedetomidine and Adenosine: Therapeutic Use for SVT
The purpose of this study is to evaluate the efficacy and safety of dexmedetomidine in the acute termination of Supraventricular Tachycardia (SVT).
- Trial name
- NCT01495481
- Testing
- Dexmedetomidine, Adenosine
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Pittsburgh
Atrial Fibrillation
Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus
Evaluating contrast enhanced ECG-gated cardiac CT (CCT) as an alternative to transesophageal echocardiography (TEE) to expedite cardioversion of atrial fibrillation (AF), improve patient care and reduce hospital admissions for AF…
- Trial name
- LACLOT (NCT04223505)
- Testing
- Contrast enhanced ECG-gated cardiac CT (CCT), Transesophageal Echocardiography (TEE)
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Persistent Atrial Fibrillation
Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)
The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Cardiac Ablation System Plus is a…
- Trial name
- PersAFOne II (NCT05152966)
- Testing
- Ablation
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis.
- Trial name
- NCT00806624
- Testing
- DU-176b tablets, Warfarin tablets
- Where
- 4 sites in China, Singapore and 2 more
- Volunteers
- 234 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Atrial Fibrillation
Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement
Primary Objective: Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the progression of adverse left atrial remodeling in patients with atrial fibrillation (AF) following 12 months of treatment.
- Trial name
- ODYSSEUS (NCT01198873)
- Testing
- Dronedarone
- Where
- 57 sites in United States, Canada
- Volunteers
- 76 people
- Sponsor
- Sanofi
Acute Coronary Syndrome
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death…
- Trial name
- AEGIS-II (NCT03473223)
- Testing
- Apolipoprotein A-I [human] (apoA-I)
- Where
- 903 sites in United States, Argentina and 47 more
- Volunteers
- 18,226 people
- Sponsor
- CSL Behring
Paroxysmal Atrial Fibrillation
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).
- Trial name
- FROZEN-AF (NCT04133168)
- Testing
- Boston Scientific Cardiac Cryoablation System
- Where
- 44 sites in United States, Belgium and 7 more
- Volunteers
- 458 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Spanish Registry of Cryoballoon Ablation
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy…
- Trial name
- RECABA (NCT02785991)
- Testing
- Balloon cryoablation
- Where
- 28 sites in Spain
- Volunteers
- 1,742 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation
Atrial fibrillation is common and increases the risk of clotting especially in patients with multiple clotting risk factors. Patients treated with warfarin, an oral anti-coagulant, require frequent lab monitoring and dose…
- Trial name
- NCT01578044
- Testing
- Intervention, Control
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Bradycardia
A Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China. The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing…
- Trial name
- COMPARE (NCT01039467)
- Testing
- Medtronic Adapta Dual Chamber Pacemaker
- Where
- 30 sites in China
- Volunteers
- 385 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ischemic Stroke
Occult Paroxysmal Atrial Fibrillation in Non-Cryptogenic Ischemic Stroke
The purpose of this study is to determine the incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.
- Trial name
- NCT02232022
- Testing
- Reveal LINQ Insertable Cardiac Monitor
- Where
- 2 sites in United States
- Volunteers
- 53 people
- Sponsor
- Northwell Health
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
Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias
A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias
- Conditions
- Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
- Trial name
- NCT04211441
- Testing
- Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
- Where
- 2 sites in Czechia
- Volunteers
- 74 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Atrial Fibrillation, Stroke
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.
- Trial name
- PREVAIL (NCT01182441)
- Testing
- WATCHMAN Device, Warfarin
- Where
- 41 sites in United States
- Volunteers
- 407 people
- Sponsor
- Boston Scientific Corporation
Systolic Heart Failure, Atrial Fibrillation (Permanent)
Junctional AV Ablation in CRT-D: JAVA-CRT
Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for patients with heart failure with reduced ejection fraction and specific indication.
- Trial name
- NCT02946853
- Testing
- Atrioventricular junctional (AVJ) ablation, Cardiac resynchronization therapy - defibrillator
- Where
- 21 sites in United States
- Volunteers
- 26 people
- Sponsor
- University of Rochester
Atrial Fibrillation, Esophagectomy
Prevention of Atrial Fibrillation Following Esophagectomy
The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following esophagectomy surgery.
- Trial name
- NCT00420017
- Testing
- Amiodarone, Control
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Indiana University
Atrial Fibrillation
Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring
Atrial fibrillation (AF) is the most common sustained abnormal rhythm of the heart, affects an estimated 2.5 to 5 million individuals in the US, and can lead to stroke, heart failure, and premature death.
- Trial name
- REACT COM (NCT01706146)
- Testing
- Non-coumadin Oral Anticoagulant
- Where
- 3 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- Northwestern University
Atrial Fibrillation, AFib
Stroke Feasibility Study
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage.
- Trial name
- NCT01997905
- Testing
- AtriClip LAA Exclusion Device
- Where
- 7 sites in United States
- Volunteers
- 13 people
- Sponsor
- AtriCure, Inc.