Clinical trials: Arrythmia
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
Foresight Intracardiac Echocardiography System (ICE)
This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation ablation procedures.
- Trial name
- NCT03239444
- Testing
- Intracardiac echocardiography imaging
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- Conavi
Atrial Fibrillation
Subtherapeutic INR Levels in Patients With AVK: Incidence, Associated Factors, Prognosis and Control Strategies
This prospective observational study is to assess the predictive factors of poor control of international normalized ratio (INR) to determine the treatment strategies received by patients with a poor control of INR in real-life…
- Trial name
- SULTAN (NCT02610153)
- Testing
- Vitamin K Antagonist
- Where
- Spain
- Volunteers
- 1,013 people
- Sponsor
- Bayer
Atrial Fibrillation
Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation
Atrial fibrillation is associated with increased risk of stroke mostly because of clot formation in the left atrial appendage, a small alcove in the left atrium heart chamber.
- Trial name
- NCT03526471
- Testing
- Omega™ Left Atrial Appendage (LAA) Occluder
- Where
- 2 sites in Denmark, Thailand
- Volunteers
- 20 people
- Sponsor
- Vascular Innovations Co. Ltd.
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.
Cardiovascular Diseases, Atrial Fibrillation
A Digital Flu Intervention for People With Cardiovascular Conditions
A 6-month prospective, digital randomized controlled trial targeting approximately 49,000 individuals to evaluate the effectiveness of an influenza vaccination intervention during influenza season for people with cardiovascular…
- Conditions
- Cardiovascular Diseases, Atrial Fibrillation, Abnormal Heart Rhythms, Cardiac Arrest
- Trial name
- CardioFlu (NCT04584645)
- Testing
- Targeted digital intervention
- Where
- United States
- Volunteers
- 49,138 people
- Sponsor
- Evidation Health
Arrhythmias
Monitoring Arrhythmia Patients in in Hospital Monitoring
This is a prospective, single center, non-randomized study to evaluate the arrhythmia monitoring performance of the AVIVO™ System in a hospital setting.
- Trial name
- ADAM (NCT00919646)
- Volunteers
- 30 people
- Sponsor
- Corventis, Inc.
Atrial Fibrillation, Obesity
Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare
The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (NVAF) who…
- Conditions
- Atrial Fibrillation, Obesity, Anticoagulants
- Trial name
- NCT04681482
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 107,383 people
- Sponsor
- Pfizer
Atrial Fibrillation, Atrial Flutter
A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of…
- Trial name
- GUARD-AF (NCT04126486)
- Testing
- Zio®XT Monitor
- Where
- 176 sites in United States
- Volunteers
- 11,931 people
- Sponsor
- Bristol-Myers Squibb
Heart Failure, Tachyarrhythmia
Iperia/Sentus QP Study
The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.
- Trial name
- NCT02181686
- Where
- 24 sites in Austria, Denmark and 9 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.
- Trial name
- CAPstopsLSPAF (NCT01103661)
- Testing
- Numeris®-AF Guided Coagulation System with VisiTrax®
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- nContact Surgical Inc.
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
Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer
The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a…
- Trial name
- CSP Display (NCT07733960)
- Testing
- CSP Display research system
- Where
- 2 sites in India
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Left Bundle-Branch Block
LV Only MPP With SyncAV
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy…
- Trial name
- NCT03567096
- Testing
- BiV pacing with MPP and SyncAV, LV only pacing with MPP and SyncAV
- Where
- 6 sites in Canada, France and 2 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
Atrial Fibrillation, Afib
Clinical Performance of the AFGen1 Device Over a 7-day Period
AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib.
- Conditions
- Atrial Fibrillation, Afib, Irregular Heart Beat, Arrhythmias, Cardiac
- Trial name
- NCT05295056
- Testing
- AFGen1 Device Wear Test, AFGen 1 Device Single Use
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- TriVirum, Inc.
Atrial Fibrillation (AF), Paroxysmal AF
Dose Escalation Study to Assess Safety, Tolerability, and Efficacy of Budiodarone Treatment With Non-permanent Atrial Fibrillation
This multicenter, open-label study aims to assess the safety, tolerability and efficacy of budiodarone in treating participants with non-permanent AF, in particular paroxysmal atrial fibrillation (PAF).
- Trial name
- Harbor-AF (NCT07792239)
- Testing
- Budiodarone 200 mg BID, Budiodarone 400 mg BID, Budiodarone 600 mg BID
- Where
- 4 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Xyra, LLC
Arrhythmias
Identification for the Treatment of Complex Arrhythmias
The primary purpose of this trial is to demonstrate that the utilization of CartoFinder™ 4D Local Activation Time (LAT) Algorithm may help identify and improve the outcome for the treatment of complex arrhythmias.
- Trial name
- NCT02565069
- Testing
- CartoFinder™ Device with CARTO® 3 System V5 Navigation
- Where
- 4 sites in Belgium, Czechia
- Volunteers
- 70 people
- Sponsor
- Biosense Webster, Inc.
Paroxysmal Atrial Fibrillation
IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System
IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
- Trial name
- IMPACT (NCT03700372)
- Testing
- IOWA Approach Cardiac Ablation System
- Where
- France
- Volunteers
- 7 people
- Sponsor
- Boston Scientific Corporation
Ventricular Arrythmia, Lead
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE…
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Trial name
- FRIENDS (NCT03766919)
- Testing
- Implant of the INVICTA lead
- Where
- 10 sites in France, Italy and 2 more
- Volunteers
- 33 people
- Sponsor
- MicroPort CRM