Clinical trials: Arrythmia, Cardiac
Atrial Fibrillation
Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up Study
Multi-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate the immediate and long-term procedural success of Lifetech LAmbre™ occluders in patients.
- Trial name
- LISA (NCT03666780)
- Testing
- LAmbre Occluder
- Where
- 26 sites in China, Denmark and 7 more
- Volunteers
- 500 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation
Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation
A prospective, two-arm, multi-center, randomized, open-label, pre-market, First-in-Human clinical study designed to provide safety and performance data regarding the use of the Adagio PFA and PFCA Systems in the treatment of PsAF.
- Trial name
- PARALELL (NCT05408754)
- Testing
- Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF.
- Where
- 6 sites in Belgium, Canada and 4 more
- Volunteers
- 89 people
- Sponsor
- Adagio Medical
ATRIAL FIBRILLATION, Syncope
BioMonitor Master Study
The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation.
- Trial name
- BioMonitor (NCT01725568)
- Testing
- BioMonitor
- Where
- Germany
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Bradyarrhythmia
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
- Trial name
- OPTI-MIND 2 (NCT01715558)
- Where
- 39 sites in Belgium, Denmark and 7 more
- Volunteers
- 514 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (Paroxysmal), Paroxysmal AF
3-Dimensional Mapping System: The PULSTAR II Study
### Study Overview Study Name In simple terms, this study involves using a new device to treat a heart condition called "Paroxysmal Atrial Fibrillation." Sponsor The study is sponsored by a company called Shanghai Shangyang…
- Conditions
- Atrial Fibrillation (Paroxysmal), Paroxysmal AF, Pulsed Field Ablation
- Trial name
- PAF (NCT07586176)
- Testing
- Nanosecond pulsed electric field ablation system; Cardiac Pulsed Electric Field Ablation Catheter
- Where
- China
- Volunteers
- 152 people
- Sponsor
- Shanghai Shangyang Medical Technology Co., Ltd.
Paroxysmal Atrial Fibrillation
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard…
- Trial name
- NCT04356040
- Testing
- TactiFlex SE, TactiFlex SE - High Standard Power
- Where
- 45 sites in United States, Australia and 8 more
- Volunteers
- 355 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Evaluation of Blood Pressure Monitor With AFib Screening Feature
This study aims to evaluate the safety and effectiveness of the Omron blood pressure (BP) monitor with AFib screening feature. The primary outcome is to validate if the Omron BP-monitor with AFib screening feature meets…
- Trial name
- NCT05599308
- Testing
- OMRON blood pressure monitor with AFib screening feature, Microlife WatchBP Home A
- Where
- 5 sites in United States
- Volunteers
- 574 people, healthy volunteers welcome
- Sponsor
- Omron Healthcare Co., Ltd.
COPD, Sepsis
Effect of Nebulized Bronchodilators on Heart Rate
The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.
- Conditions
- COPD, Sepsis, Shock
- Trial name
- NCT01151579
- Testing
- Levalbuterol, Albuterol
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- Fahim Khorfan, MD
Arrhythmias, Cardiac, Bradycardia
Cardiac Implantable Electronic Device (CIED) Research Study
The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures.
- Conditions
- Arrhythmias, Cardiac, Bradycardia, Tachycardia
- Trial name
- NCT05061862
- Testing
- cardiac implantable electronic devices (CIEDs)
- Where
- 9 sites in United States, Belgium
- Volunteers
- 1,000 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Persistent Atrial Fibrillation
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in…
- Trial name
- NCT07106970
- Testing
- Linear ablation, PVI alone
- Where
- China
- Volunteers
- 640 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Cardiac Arrhythmia
Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronization
BIO|Adapt study is designed to provide evidence for the clinical benefit of the CRT AutoAdapt feature. This feature provides continuous adaptation of AV delay and biventricular pacing modality.
- Conditions
- Heart Failure, Cardiac Arrhythmia, Left Ventricular Dysfunction
- Trial name
- BIO|Adapt (NCT04774523)
- Testing
- Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature., Echocardiography AV optimization, Echocardiography
- Where
- Spain
- Volunteers
- 198 people
- Sponsor
- Biotronik SE & Co. KG
Arrhythmias, Cardiac, Atrial Fibrillation
Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping
The trial is a prospective, non-randomized, single-arm feasibility trial to evaluate physician acceptance of the NeuTrace System v1.0 for cardiac electroanatomic mapping.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
- Trial name
- NCT05214170
- Testing
- Electroanatomic mapping with the NeuTrace System
- Where
- Lithuania
- Volunteers
- 20 people
- Sponsor
- NeuTrace, Inc.
Ventricular Tachycardia, Ventricular Fibrillation, Heart Failure
Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following
The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE Cardiac Resynchronization Therapy ICD (CRT-D)…
- Trial name
- Cogent-4 (NCT00606710)
- Testing
- Cognis 100-D, Teligen DR, VR 100 HE
- Where
- 4 sites in Denmark, Israel
- Volunteers
- 450 people
- Sponsor
- Guidant Corporation
Atrial Fibrillation
Management of Gastrointestinal and Urogenital (GI/GU) Bleedings in Atrial Fibrillation Patients Using Pradaxa
This study is being conducted to collect data on the management of gastrointestinal and urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.
- Trial name
- NCT02022020
- Where
- 22 sites in United States, Canada
- Volunteers
- 220 people
- Sponsor
- Boehringer Ingelheim
Premature Ventricular Contraction, Ventricular Tachycardia
VIVO™ Accuracy Study
A multi-center study designed to assess the accuracy of VIVO™ in determining the location of a PVC/VT foci in comparison to an electroanatomical mapping system.
- Trial name
- NCT03340142
- Testing
- VIVO™
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Catheter Precision. Inc.
Ventricular Fibrillation, Ventricular Tachycardia
Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy
The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces death from any cause.
- Trial name
- REFORM (NCT00401466)
- Testing
- Implantable Cardioverter Defibrillator
- Where
- 5 sites in Czechia, Germany
- Volunteers
- 155 people
- Sponsor
- Biotronik SE & Co. KG
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
HD Mapping of Atrial Fibrillation in Asia Pacific
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop…
- Trial name
- NCT04022954
- Testing
- Catheter ablation
- Where
- 15 sites in China, Hong Kong and 3 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.
- Trial name
- LIBREXIA-AF (NCT05757869)
- Testing
- Milvexian, Apixaban
- Where
- 1,052 sites in United States, Argentina and 37 more
- Volunteers
- 20,284 people
- Sponsor
- Janssen Research & Development, LLC
Bradyarrhythmia
Micra Accelerometer Sensor Study 2
The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future…
- Trial name
- MASS2 (NCT02930980)
- Testing
- Investigational Software loaded on Micra device
- Where
- 4 sites in Austria, France and 1 more
- Volunteers
- 43 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia, Ventricular Arrythmia
Extravascular ICD Pilot Study
The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.
- Trial name
- EV ICD (NCT03608670)
- Testing
- Defibrillation using the Extravascular ICD
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 26 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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