Clinical trials: Heart Rhythm Disorders
Bradyarrhythmia
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.
- Trial name
- OPTI-MIND (NCT00976482)
- Where
- Germany
- Volunteers
- 1,745 people
- Sponsor
- Boston Scientific Corporation
Tachyarrhythmia, Atrial Fibrillation (AF)
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk…
- Conditions
- Tachyarrhythmia, Atrial Fibrillation (AF), Syncope, Cryptogenic Stroke
- Trial name
- NCT04025710
- Testing
- BIOMONITOR III and BIOMONITOR IIIm
- Where
- 27 sites in Australia, Austria and 4 more
- Volunteers
- 167 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Fibrillation
Acute Feasibility Investigation of a New S-ICD Electrode
This is an early-stage feasibility study. This study seeks to characterize the performance of the new electrode shock configuration with the S-ICD
- Trial name
- ASE (NCT03802110)
- Testing
- commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.
- Where
- 4 sites in Netherlands
- Volunteers
- 42 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Atrial Pressure Electrophysiology Pilot Study
This study examined data elements of hemodynamic, electrophysiologic and electrolyte trends comparing 2 different types of catheters used during a procedure to treat medication resistant atrial fibrillation-radiofrequency…
- Trial name
- APES (NCT01845974)
- Testing
- ThermoCool® SF NAV Catheter, ThermoCool® catheter
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Wake Forest University Health Sciences
Atrial Fibrillation
Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period.
- Trial name
- NCT03187197
- Testing
- Pradaxa®
- Where
- 24 sites in Taiwan
- Volunteers
- 1,315 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Feasibility of Perioperative Stellate Ganglion Blocks in Cardiac Surgery
Based upon Northern New England Cardiovascular Study Group data, the rate of post operative atrial fibrillation (POAF) requiring treatment following coronary artery bypass grafting (CABG) at Maine Medical Center (MMC) is…
- Trial name
- NCT02784587
- Testing
- Stellate Ganglion Block
- Volunteers
- 25 people
- Sponsor
- Christopher Connors, MD
Mitral Valve Insufficiency, Atrial Fibrillation
Left Atrial Distensibility to Predict Left Ventricular Filling Pressure and Prognosis in Patients With Severe Mitral Regurgitation
A large left atrial (LA) volume, which represents chronic diastolic dysfunction, is associated with a poor outcome, regardless of systolic function.
- Conditions
- Mitral Valve Insufficiency, Atrial Fibrillation, Heart Failure
- Trial name
- NCT01172184
- Testing
- Cardiac catheterization
- Where
- Taiwan
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Kaohsiung Veterans General Hospital.
Arrhythmia
Observation of ImageReady™ MR Conditional Defibrillation System in China
To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.
- Trial name
- NCT03451721
- Testing
- ImageReady™ MR Conditional Defibrillation System
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Catecholaminergic Polymorphic Ventricular Tachycardia
Atropine in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
To test the hypothesis that increasing the sinus node rate with atropine treatment prior to exercise will reduce exercise-triggered ventricular ectopy compared to baseline in patients with CPVT.
- Trial name
- NCT02927223
- Testing
- Atropine, Exercise treadmill test
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt University
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
Arrhythmia, Tachycardia
CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen…
- Conditions
- Arrhythmia, Tachycardia, Atrial Fibrillation, Ventricular Fibrillation
- Trial name
- CONNECT (NCT00402246)
- Testing
- Remote Management, In-Office Care
- Where
- 127 sites in United States
- Volunteers
- 2,009 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Postural Orthostatic Tachycardia Syndrome
Dietary Sodium's Effect on Urinary Sodium and Dopamine Excretion in Patients With Postural Tachycardia Syndrome
Patients with Postural Tachycardia Syndrome (POTS) may not adequately expand their plasma volume in response to a high sodium diet.
- Trial name
- NCT01563107
- Testing
- Plasma Volume, Exercise Capacity Test - Bicycle, Posture Study
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Cardiac Arrhythmia
A Comparative Study of an Innovative 3-lead Wireless Water Resistant Holter System and a Conventional Holter System
Holter monitoring is one of the most widely used diagnostic methods to detect cardiac arrhythmias. Newer Holter monitors may provide some advantages over the more traditional ones.
- Trial name
- NCT04723355
- Testing
- An innovative 3-lead wireless water resistant Holter device, A conventional device
- Where
- Brazil
- Volunteers
- 231 people, healthy volunteers welcome
- Sponsor
- Hospital Israelita Albert Einstein
Arrhythmia
PORTuguese Research on Telemonitoring With CareLink® (PORTLink)
Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)
- Trial name
- PORTLink (NCT03125382)
- Testing
- Carelink System, In office standard visit
- Where
- 6 sites in Portugal
- Volunteers
- 141 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
China Micra Transcatheter Pacing Study
The China Micra Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical trial utilizing Objective Performance Criterion (OPC) to confirm the safety and efficacy profile of the Micra system for…
- Trial name
- NCT03624504
- Testing
- Micra Transcatheter Pacing System (TPS)
- Where
- 7 sites in China
- Volunteers
- 82 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Atrial Flutter
Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation
The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk…
- Trial name
- ARISTOTLE (NCT00412984)
- Testing
- warfarin, apixaban
- Where
- 1,111 sites in United States, Argentina and 39 more
- Volunteers
- 20,976 people
- Sponsor
- Bristol-Myers Squibb
Deep Vein Thrombosis, Fibrillation, Atrial
Odiparcil For The Prevention Of Venous Thromboembolism
Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.
- Conditions
- Deep Vein Thrombosis, Fibrillation, Atrial, Venous Thromboembolism, Pulmonary Embolism
- Trial name
- NCT00244725
- Testing
- Odiparcil, Warfarin, Coumadin
- Where
- 101 sites in United States, Australia and 11 more
- Volunteers
- 961 people
- Sponsor
- GlaxoSmithKline
Severe Respiratory Syncytial Virus Infection
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that…
- Trial name
- NCT01075178
- Where
- 37 sites in Austria, Belgium and 8 more
- Volunteers
- 2,036 people
- Sponsor
- Abbott
Atrial Fibrillation, Atrial Fibrillation Recurrent
Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
Patients who have undergone cardiac ablation will be randomized and blinded to one of two groups; one group will receive dronedarone while the other group will receive a placebo.
- Trial name
- EDORA (NCT04704050)
- Testing
- dronedarone 400 mg Oral Tablet
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Tulane University School of Medicine
Cardiac Arrhythmia
SJM MRI Diagnostic Imaging Registry (IDE)
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically…
- Trial name
- NCT02807948
- Testing
- Pacemaker, ICD, or CRT device
- Where
- 58 sites in United States
- Volunteers
- 189 people
- Sponsor
- Abbott Medical Devices