Clinical trials: Heart Conduction Disorder
Sinus-node Dysfunction
Right Ventricular Outflow Tract Study
This is a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path…
- Trial name
- RVOTCARE (NCT01294839)
- Testing
- Right ventricular lead location
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Abbott Medical Devices
Atrioventricular Conduction Block
Micra Atrial Tracking Using a Ventricular Accelerometer Study
The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block.
- Trial name
- MARVEL (NCT03157297)
- Testing
- MARVEL algorithm
- Where
- 13 sites in United States, Austria and 7 more
- Volunteers
- 70 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
Neonates
NICU-TECH RM9L-RS Probe ME Feasibility Study
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself.
- Trial name
- NCT01181596
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- GE Healthcare
Rheumatoid Arthritis
A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart
This study is being performed to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart.
- Trial name
- NCT00887770
- Testing
- AZD5672, Moxifloxacin
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bradycardia
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate…
- Trial name
- CLEAR (NCT00355797)
- Testing
- Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
- Where
- 99 sites in United States
- Volunteers
- 1,491 people
- Sponsor
- Biotronik, Inc.
Brugada Syndrome
AnalyST & Brugada Syndrome - Feasibility Study
Brugada syndrome is characterized by a ST shift on the surface ECG, and a specific morphology of the Twave. This ECG abnormality is called a type 1-ECG, and is variable in time.
- Trial name
- NCT02052765
- Testing
- ECG continuous recording (Analyze ST)
- Where
- France
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Tachyarrhythmia
Lead Evaluation for Defibrillation and Reliability Post Approval Study
Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release.
- Trial name
- LEADR PAS (NCT07005232)
- Testing
- defibrillation lead
- Where
- 73 sites in United States, Austria and 5 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic
Conduction Defect
Subcostal Temporary Extracardiac Pacing Study
Up to 15 subjects will be enrolled to evaluate initial safety and performance of the AtaCor Temporary Pacing System. Safety will be evaluated through analysis of all Adverse Events.
- Trial name
- STEP (NCT04096365)
- Testing
- Subcostal Temporary Extracardiac Pacing Lead
- Where
- Paraguay
- Volunteers
- 12 people
- Sponsor
- AtaCor Medical, Inc.
Tachycardia
INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.
- Trial name
- NCT00148967
- Testing
- Implantable Cardioverter Defibrillator
- Volunteers
- 1,535 people
- Sponsor
- Boston Scientific Corporation
Ventricular Arrythmia, Ventricular Fibrillation
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study
The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of…
- Conditions
- Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
- Trial name
- ASCEND EV (NCT06592001)
- Testing
- Atala™ lead
- Where
- 3 sites in Croatia, New Zealand and 1 more
- Volunteers
- 19 people
- Sponsor
- AtaCor Medical, Inc.
Tachycardia, Atrioventricular Nodal Reentry
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with…
- Trial name
- PS-010 (NCT00621621)
- Testing
- Freezor® Cardiac Cryoablation Catheter CryoConsole System
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiopulmonary Failure, Myocardial Infarction (MI)
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using…
- Conditions
- Cardiopulmonary Failure, Myocardial Infarction (MI), Heart Decompensation, Heart Failure
- Trial name
- COR-INSIGHT (NCT06763549)
- Testing
- SUBPROTOCOL A, SUBPROTOCOL B, SUBPROTOCOL C
- Where
- United States
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Tachyarrhythmia
ProMRI ICD/CRT-D Post Approval Study
Following product approval, confirmation of appropriate VF episode detection after MRI exposure of the ProMRI ICD/CRT-D systems and to evaluate left ventricular pacing threshold changes post-MRI.
- Trial name
- NCT02933619
- Volunteers
- 24,249 people
- Sponsor
- Biotronik, Inc.
Sick Sinus Syndrome
Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)
The purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel algorithm to minimize ventricular pacing).
- Trial name
- NCT00161551
- Testing
- Vitatron T70 DR
- Where
- 5 sites in Germany
- Volunteers
- 402 people
- Sponsor
- Medtronic BRC
Ventricular Tachycardia, Ventricular Fibrillation
DAVID II (Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial II)
The DAVID II Clinical Study evaluates the hypothesis that, in patients needing an ICD but without overt indications for pacing, AAI pacing with maximal concomitant drug therapy will not increase the rate of the combined endpoint…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Congestive Heart Failure
- Trial name
- DAVIDII (NCT00187187)
- Testing
- Implantable Defibrillator (ICD)
- Volunteers
- 600 people
- Sponsor
- Abbott Medical Devices
Ventricular Fibrillation, Ventricular Tachycardia
Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System
The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter defibrillator (ICD)for treating ventricular…
- Trial name
- NCT00399217
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) system, ICD
- Where
- United Kingdom
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
Tachycardia
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up
- Trial name
- ISIS-ICD (NCT01410552)
- Testing
- PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770
- Where
- 80 sites in United States, France and 5 more
- Volunteers
- 1,013 people
- Sponsor
- MicroPort CRM
Cardiac Arrhythmia
EnSite Precision Observational Study
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software…
- Trial name
- NCT03260244
- Testing
- cardiac mapping and radiofrequency ablation procedure
- Where
- 7 sites in United States
- Volunteers
- 1,065 people
- Sponsor
- Abbott Medical Devices
Ventricular Tachyarrhythmia
NORDIC ICD (Cardioverter Defibrillator Implantation) Trial
The purpose of the NORDIC ICD study is to evaluate whether ICD implantation without intra-operative DF testing is non-inferior to ICD implantation with intra-operative DF testing regarding the efficacy of the first ICD shock for…
- Trial name
- NCT01282918
- Testing
- ICD implantation w/o DF test, ICD implantation with DF test
- Where
- 2 sites in Germany, Sweden
- Volunteers
- 1,077 people
- Sponsor
- Biotronik SE & Co. KG