Clinical trials: Cardiac Rhythm Disorders
Heart Failure, CPX
Pilot Study to Investigate the Creation of Physiological Rhythm by Closed Loop Stimulation in hEart Failure pAtients With chronoTropic incompEtence
The study assesses the effect of Closed Loop Stimulation (CLS) on the ventilatory efficiency slope and estimates the patient responder rate to CLS in patients with severe chronotropic incompetence treated with a cardiac…
- Trial name
- BIO|CREATE (NCT03157076)
- Testing
- Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Biotronik SE & Co. KG
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
The RECORD Asia-Pacific Atrial Fibrillation Registry
The Primary objective of this registry is to assess the control of Atrial Fibrillation (AF) over one year in patients attending clinical or specialized practices.
- Trial name
- RECORDAF-AP (NCT00995748)
- Where
- 8 sites in Australia, China and 6 more
- Volunteers
- 2,674 people
- Sponsor
- Sanofi
Atrial Fibrillation
Validation Study of Frontier X Plus (FX+) Device
The main objective of this study is to validate the specificity and sensitivity of FX+ detecting atrial fibrillation (AF) in both AF and non-AF subjects using a comparative approach, which involves using both a US FDA-cleared…
- Trial name
- NCT06471764
- Testing
- FX+ and 12-Lead ECG Recording
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Fourth Frontier Technologies Pvt Ltd.
Cardiac Rhythm Disorder, Heart Failure
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
- Conditions
- Cardiac Rhythm Disorder, Heart Failure, Sudden Cardiac Death
- Trial name
- PIANO (NCT05694572)
- Testing
- Implantation of a CIED
- Where
- Portugal
- Volunteers
- 2,500 people
- Sponsor
- MicroPort CRM
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.
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
Sick Sinus Syndrome
Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace…
- Trial name
- VIPERS (NCT01528657)
- Testing
- Ventricular Pace Suppression (Vps), Intrinsic rhythm support (IRSplus)
- Where
- 20 sites in Italy
- Volunteers
- 230 people
- Sponsor
- Biotronik SE & Co. KG
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.
Obesity
A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants
The study tests if treatment with cagrilintide delays the transmission of electrical signals in the heart compared to treatment with placebo.
- Trial name
- NCT05804162
- Testing
- Cagrilintide, Moxifloxacin
- Where
- Germany
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
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.
Atrial Fibrillation, Atrial Flutter
Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter
Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.
- Trial name
- MAIA (NCT00233441)
- Testing
- CELIVARONE (SSR149744C)
- Where
- 17 sites in United States, Argentina and 15 more
- Volunteers
- 673 people
- Sponsor
- Sanofi
Cardiac Event
PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard
The purpose of this study is to determine the incidence of clinically significant rhythm and rate changes in ED patients who are not placed on conventional telemetry, and to test the user-friendliness of a automated clinician…
- Trial name
- PREVENT (NCT00750958)
- Testing
- NetGuard Automated Clinician Alert System
- Where
- 2 sites in United States
- Volunteers
- 287 people, healthy volunteers welcome
- Sponsor
- Datascope Patient Monitoring
Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal)
Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation
The goal of this observational study is to confirm the accuracy of the sleep algorithm (software) used in the Rhythm Express Wearable System to detect sleep apnea severity.
- Conditions
- Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal), Palpitations
- Trial name
- NCT06907888
- Testing
- Rhythm Express Wearable System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- VivaQuant
Heart Failure, Cardiomyopathy
Clinical Evaluation on Advanced Resynchronization
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.
- Trial name
- NCT00658203
- Testing
- New Living CHF
- Where
- 36 sites in France, Germany and 4 more
- Volunteers
- 310 people
- Sponsor
- LivaNova
Atrial Fibrillation
This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain
The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.
- Trial name
- RE-CONOCE (NCT03285373)
- Testing
- NOAC
- Where
- 75 sites in Spain
- Volunteers
- 1,008 people
- Sponsor
- Boehringer Ingelheim
Heart Diseases, Rhythm; Abnormal
BIO|CONCEPT.ECG-Library (Collection of ECG Signals for Development of Algorithms)
Collection of Holter surface ECGs for the development of new sensing and detection algorithms
- Trial name
- NCT04243070
- Testing
- 3-channel Holter ECG recording, 12-channel Holter ECG recording
- Where
- 5 sites in Germany
- Volunteers
- 89 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Atrial Arrhythmia
Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation (ReSync AF)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00268294
- Testing
- Cardiac Resynchronization Therapy
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Disease
BoStOn SCientific Rhythm MAnagemenT REgiStry
SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the…
- Trial name
- SOCRATES (NCT04823663)
- Testing
- Implant, Electrophysiologic procedure
- Where
- 26 sites in Belgium, Canada and 8 more
- Volunteers
- 12,500 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Atrial Flutter
American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm
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
- ADONIS (NCT00259376)
- Testing
- Dronedarone (SR33589)
- Where
- 5 sites in United States, Argentina and 3 more
- Volunteers
- 629 people
- Sponsor
- Sanofi