Clinical trials: Cardiac Rhythm Disorders
Bradycardia, Tachycardia
Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)".
- Trial name
- ASSUREMRI (NCT03012568)
- Testing
- SJM Implantable cardiac devices
- Where
- 3 sites in Australia, India
- Volunteers
- 119 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Arrythmia
Design and Rationale of the Assessment of the MindMics Recording System
MindMics earbuds is a new technology designed enhance an individual's quality of life by continuously monitoring the heart rate, stress, and blood pressure allowing patients to make decisions regarding their health.
- Trial name
- NCT05103579
- Testing
- MindMics
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- MindMics Inc
Cardiac Pacemaker, Cardiac Rhythm Disorder
AVEIR Remote Care System Non-Significant Risk Study
The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP…
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT06542133
- Testing
- AVEIR remote care system
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Rhythm; Disorder
REmote CArdiac MOnitoring by the Corsano CardioWatch 287-2 Evaluation Study
In this study, a wristband that monitors hearth rhythm and blood pressure is assessed in free living conditions. Two groups of patients are being recruited: patients receiving an EKG holter and patients receiving an automatic…
- Conditions
- Atrial Fibrillation, Rhythm; Disorder, Palpitations, Hypertension
- Trial name
- RECAMO (NCT05899959)
- Testing
- Corsano CardioWatch 287-2
- Where
- Netherlands
- Volunteers
- 190 people
- Sponsor
- Corsano Health B.V.
Cardiac Pacemaker, Cardiac Rhythm Disorder
LEAP 2 Chronic EFS
Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT07287423
- Testing
- AVEIR CSP Leadless Pacemaker System
- Where
- Czechia
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Paroxysmal Atrial Fibrillation
A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.
- Trial name
- NCT00540787
- Testing
- Radiofrequency ablation, antiarrhythmic drugs, Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs, ThermoCool Radiofrequency Catheter
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 112 people
- Sponsor
- Biosense Webster, Inc.
Cardiac Pacemaker, Arrythmia
Aveir DR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05935007
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 1,805 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Flutter
EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)
To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).
- Trial name
- EURIDIS (NCT00259428)
- Testing
- Dronedarone (SR33589)
- Where
- 12 sites in Belgium, Czechia and 10 more
- Volunteers
- 615 people
- Sponsor
- Sanofi
Paroxysmal Atrial Fibrillation (PAF)
INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT)
The study consisted of 3 parts (Part A, Part B and Part C). Part A was an open-label, randomized, multi center design to evaluate the feasibility of administration of inhaled flecainide in two dosing regimens.
- Trial name
- INSTANT (NCT03539302)
- Testing
- Flecainide Acetate
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 176 people
- Sponsor
- InCarda Therapeutics, Inc.
Hyperkalemia
POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
This study assesses serum potassium and cardiac rhythm trends in subjects with end stage renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days.
- Trial name
- PORTEND (NCT02609841)
- Testing
- Cardiac rhythm remote monitoring system
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- ZS Pharma, Inc.
Atrial Fibrillation
International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)
This study will create a prospective registry of consecutive patients with Atrial Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of in-hospital treatment, with a focus on the…
- Trial name
- RHYTHM-AF (NCT01119716)
- Volunteers
- 4,658 people
- Sponsor
- Merck Sharp & Dohme LLC
Persistent Atrial Fibrillation
WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm
WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and effectiveness data on combining conventional AF ablation with LAA electric isolation and closure within a single procedure.
- Trial name
- WATCH-Rhythm (NCT03835338)
- Testing
- Pulmonary Vein Isolation, LAA Isolation, LAA Occlusion
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF)
This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in…
- Trial name
- PROMISE-AF (NCT03906799)
- Testing
- OMT-28
- Where
- 25 sites in Bulgaria, Czechia and 2 more
- Volunteers
- 136 people
- Sponsor
- Omeicos Therapeutics GmbH
Heart Rhythm Disorders
PANORAMA 2 Observational Study
Understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in real world patient population is…
- Trial name
- NCT01723566
- Where
- Egypt
- Volunteers
- 4,706 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Efficacy and Safety Study of F373280
The purpose of this study is to assess the efficacy of F373280 on the maintenance of normal cardiac rhythm after direct electric cardioversion in patients with persistent atrial fibrillation and cardiac failure.
- Trial name
- NCT01831856
- Testing
- 1g of F373280
- Where
- 20 sites in Czechia, Hungary and 3 more
- Volunteers
- 135 people
- Sponsor
- Pierre Fabre Medicament
Arrhythmia
Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease
The purpose of this study is to learn the effects of a test drug on heart rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe.
- Trial name
- NCT00137332
- Testing
- GAP-486 (ZP-123), 0.9% Sodium Chloride, USP
- Where
- 33 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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.
Cardiac Pacemaker, Arrythmia
Aveir VR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05270499
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 3,427 people
- Sponsor
- Abbott Medical Devices
Cardiac Rhythm Disturbance
Hexoskin Medical System - ECG Performance Testing
The goal of this observational study is to validate the efficacy of the Hexoskin Medical System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in non-critical adult participants who are…
- Trial name
- NCT05970328
- Testing
- Hexoskin Medical System
- Where
- 2 sites in Canada
- Volunteers
- 75 people
- Sponsor
- Carré Technologies Inc.
Atrial Fibrillation, Atrial Flutter
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.
- Trial name
- NCT00126022
- Testing
- Tedisamil sesquifumarate
- Where
- 81 sites in United States, Argentina and 11 more
- Sponsor
- Solvay Pharmaceuticals