Clinical trials: Cardiac Rhythm Disorders
Heart Failure, Cardiac Resynchronization Therapy
Safety and Performance Aspects of CRT-DX System in Patients With Sinus Rhythm
The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium.
- Trial name
- BIO|REDUCE (NCT03839121)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- 21 sites in Austria, Czechia and 2 more
- Volunteers
- 113 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
- Trial name
- TUNDRA-AF (NCT01259622)
- Testing
- saline, K201
- Where
- 17 sites in Denmark, Israel
- Volunteers
- 80 people
- Sponsor
- Sequel Pharmaceuticals, Inc
Heart Failure
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted…
- Trial name
- RHYTHM (NCT04491136)
- Testing
- ACEI/ARB, ARNI
- Where
- 23 sites in China
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
Atrial Fibrillation (AF)
Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
- Trial name
- END-AF-1 (NCT07267949)
- Testing
- AP31969
- Where
- 46 sites in Bulgaria, Denmark and 6 more
- Volunteers
- 200 people
- Sponsor
- Acesion Pharma
Atrial Fibrillation (AF), Atrial Premature Complexes
Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
The goal of this clinical trial is to evaluate the safety and efficacy of medical device Kardi Ai, an ECG telemetry monitoring device in adult population.
- Conditions
- Atrial Fibrillation (AF), Atrial Premature Complexes, Ventricular Premature Complexes, Bradycardia
- Trial name
- Kardi Ai (NCT07018648)
- Testing
- Medical device
- Where
- 2 sites in Czechia
- Volunteers
- 115 people
- Sponsor
- KARDI AI Technologies s.r.o.
Cardiac Rhythm Disorder, Bradycardia
Patient Preferences for Leadless Pacemakers
Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers
- Conditions
- Cardiac Rhythm Disorder, Bradycardia, Cardiac Pacemaker Artificial
- Trial name
- NCT05327101
- Testing
- Patient Preference Survey
- Where
- 11 sites in United States
- Volunteers
- 117 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Premature Atrial and Ventricular Beats
A Study to Determine the Feasibility of Wireless Electrocardiography
The investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and…
- Conditions
- Atrial Fibrillation, Premature Atrial and Ventricular Beats, Conduction Defects, Normal Sinus Rhythm
- Trial name
- NCT02162394
- Testing
- Observational ambulatory ECG monitoring
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Peerbridge Health, Inc
Tachycardia
RIGHT: Rhythm ID Going Head-to-Head Trial
RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy of VITALITY 2 implantable cardioverter defibrillators (ICDs) using Rhythm ID™ versus selected Medtronic ICDs.
- Trial name
- NCT00148954
- Testing
- VITALITY 2 Implantable Cardioverter Defibrillator, Medtronic Implantable Cardioverter Defibrillator
- Where
- United States
- Volunteers
- 1,962 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Detection of Heart Rhythm and BP With RhythmPadBP
This study will assess a new device, the RhythmPadBP, which detects heart rhythm and measure blood pressure simply by placing palms of the hands on a pad containing titanium electrodes.
- Trial name
- SLAF-BP (NCT03813446)
- Testing
- Device: RhythmPadBP
- Where
- United Kingdom
- Volunteers
- 1,100 people, healthy volunteers welcome
- Sponsor
- Cardiocity Limited
Insomnia
Brain and Heart Rhythm Responses to a Breathing-Linked Sound Application (BELL-001) in Adults With Insomnia Symptoms
The purpose of this study was to describe how brain activity and heart rhythm respond to BELL-001, a smartphone application that plays sounds linked to the user's own breathing, compared with a sham application that looks the…
- Trial name
- NCT07872007
- Testing
- BELL-001 Digital Therapeutic
- Where
- South Korea
- Volunteers
- 72 people
- Sponsor
- BELL Therapeutics Inc.
Cardiac Rhythm Disorder, Bradycardia
The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System
prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
- Trial name
- NCT04559945
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- 53 sites in United States, Canada and 6 more
- Volunteers
- 1,276 people
- Sponsor
- Abbott Medical Devices
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.
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
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
A Study to Compare the Effect on Heart Rhythm of 3 Days of GSK189075, Placebo, or Moxifloxacin in Healthy Adults
This study assesses for change in heart rhythm of healthy volunteers taking GSK189075 for 3 days at a normal dose and a higher than normal dose compared to placebo or to a single dose of moxifloxacin.
- Trial name
- NCT00532610
- Testing
- GSK189075
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Atrial Fibrillation
Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)
Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that puts them at risk of developing clots in the heart.
- Trial name
- EMANATE (NCT02100228)
- Testing
- Apixaban, Parenteral heparin and/or oral Vitamin K antagonist
- Where
- 165 sites in United States, Belgium and 10 more
- Volunteers
- 1,500 people
- Sponsor
- Pfizer
Heart Failure (NYHA Class III and Ambulatory IV)
Continued Access Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
The objective of the Continued Access study is to gather confirmatory evidence on the safety of the SonRtip lead and performance of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm…
- Trial name
- RESPOND-CAS (NCT02374801)
- Testing
- SonR automatic optimization feature turned ON ("AV+VV").
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- MicroPort CRM
Atrial Fibrillation
A Digital Non-interventional Atrial Fibrillation (AF) Screening Study With Commercial Pulse Detection Systems
The primary objective in this study is to identify commercial pulse detection systems (CPDS) parallel to electrocardiogram (ECG) recording within routine clinical setting, which are able to detect atrial fibrillation or sinus…
- Trial name
- BAYathlon (NCT02875106)
- Testing
- 12-point-ECG, Polar V800, 360° eMotion FAROS SET + Belt
- Where
- Germany
- Volunteers
- 165 people
- Sponsor
- Bayer
Arrhythmia, Cardiac
A Study to Describe the Effectiveness of Arrhythmia Analysis Software for Screening of Sinus Rhythm, Atrial Fibrillation and Premature Beats in light-and Dark Skin Tone Patients
The purpose of this study is to describe the Huawei'ssoftware ("Arrhythmia Analysis Software") for the detection of atrial fibrillation, premature beats, and sinus rhythm using photoplethysmography (PPG).
- Trial name
- NCT05437926
- Testing
- Arrhythmia Analysis Software (software) which runs on a mobile application (Huawei Phone) and uses input from a wearable device (smart watch or smart band).
- Where
- Netherlands
- Volunteers
- 102 people
- Sponsor
- Huawei Device Co., Ltd
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