Clinical trials: Conduction Defect, Cardiac
Ventricular Arrhythmia, Ventricular Tachycardia
Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study
The PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely…
- Conditions
- Ventricular Arrhythmia, Ventricular Tachycardia, Ventricular Fibrillation
- Trial name
- PASS PULL (NCT05099289)
- Testing
- AtaCor EV-ICD Lead
- Where
- Paraguay
- Volunteers
- 18 people
- Sponsor
- AtaCor Medical, Inc.
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
Conduction Defect
Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study
The PIONEER EV PACING Study is prospective, multi-center, acute (in-hospital), single-arm, pilot study. The study objective is to characterize preliminary safety and performance of the AtaCor EV Temporary Pacing Lead System when…
- Trial name
- NCT05610033
- Testing
- AtaCor StealthTrac Lead
- Where
- Croatia
- Volunteers
- 12 people
- Sponsor
- AtaCor Medical, Inc.
Ventricular Tachycardia, Arrythmia
Rook Epicardial Access Device Study
The purpose of this study is to confirm the efficacy and safety of the Talon Surgical Rook® Epicardial Access Kit as a pericardial access device.
- Trial name
- NCT03427333
- Testing
- The Rook® Epicardial Access Kit
- Where
- Czechia
- Volunteers
- 13 people
- Sponsor
- Talon Surgical
Tachyarrhythmia
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD…
- Trial name
- NCT04863664
- Testing
- Defibrillation (RV Implant), Defibrillation (LBBAP Implant)
- Where
- 55 sites in United States, Australia and 18 more
- Volunteers
- 998 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachycardia, Cardiovascular Diseases
Genetic Substudy of the Alternans Before Cardioverter Defibrillator (ABCD) Trial
The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in…
- Conditions
- Ventricular Tachycardia, Cardiovascular Diseases, Arrythmia, CVD
- Trial name
- ABCD (NCT00583297)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- CardioDx
Atrial Fibrillation, Tachycardia
Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
The SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects…
- Conditions
- Atrial Fibrillation, Tachycardia, Bradycardia, Premature Supraventricular Beat
- Trial name
- NCT05167058
- Testing
- Cardiologs Platform
- Where
- 3 sites in United States
- Volunteers
- 220 people
- Sponsor
- Cardiologs Technologies
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
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
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
Cardiac Arrhythmia
Novel Cardiac Signal Processing System
This study is designed to collect parallel intracardiac signal data during pre-defined periods of clinical interest from the PURE EP system and the existing signal recording and mapping systems.
- Trial name
- NCT04112433
- Testing
- PURE EP 2
- Where
- 3 sites in United States
- Volunteers
- 104 people
- Sponsor
- BioSig Technologies, Inc.
Arrhythmias, Cardiac, Atrial Fibrillation
AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection
The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinics.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Bradycardia
- Trial name
- VALID-ECG (NCT06123130)
- Testing
- Vectorcardiography (VECG)
- Where
- 5 sites in United States
- Volunteers
- 198 people
- Sponsor
- HeartBeam, Inc.
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
Sudden Cardiac Death, Sudden Cardiac Arrest
Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. This study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident…
- Trial name
- WED-HED (NCT02481206)
- Testing
- Wearable Cardioverter Defibrillator
- Where
- 31 sites in United States
- Volunteers
- 66 people
- Sponsor
- Zoll Medical Corporation
Heart Failure, Tachyarrhythmia
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family
Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by demonstrating clinical safety evaluating performance based…
- Trial name
- NCT05621187
- Testing
- Pamira ICD lead family
- Where
- 23 sites in Australia, Austria and 6 more
- Volunteers
- 221 people
- Sponsor
- Biotronik SE & Co. KG
Sick Sinus Syndrome
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.
- Trial name
- NCT00161538
- Testing
- Pacing leads to be implanted according randomization., Selection 9000 prevent AF an Diagnose AF
- Where
- 12 sites in Germany
- Volunteers
- 456 people
- Sponsor
- Medtronic BRC
Tachycardia, Diabetes Mellitus
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
The MADIT S-ICD trial was designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous…
- Conditions
- Tachycardia, Diabetes Mellitus, Cardiovascular Disease
- Trial name
- MADIT S-ICD (NCT02787785)
- Testing
- Subcutaneous Implantable Cardioverter Defibrillator
- Where
- 49 sites in United States, Germany and 5 more
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Heart Failure With Reduced Ejection Fraction
Assessment of Combined CCM and ICD Device in HFrEF
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy
- Trial name
- INTEGRA-D (NCT05855135)
- Testing
- OPTIMIZER® Integra CCM-D System (Treatment Arm)
- Where
- 59 sites in United States
- Volunteers
- 300 people
- Sponsor
- Impulse Dynamics
Hypertrophic Cardiomyopathy, Nonsustained Ventricular Tachycardia
Extended ECG Monitoring in HCM Patients
The purpose of this study is to determine, among a large cohort of 300 consecutive patients with hypertrophic cardiomyopathy, if extended ambulatory monitoring using the iRhythm Technologies, Inc.
- Conditions
- Hypertrophic Cardiomyopathy, Nonsustained Ventricular Tachycardia, Ventricular Tachycardia, Atrial Fibrillation
- Trial name
- EXAMINE-HCM (NCT04056715)
- Testing
- Zio XT
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- iRhythm Technologies, Inc.
Tachycardia, Ventricular Fibrillation
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
- Conditions
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
- Trial name
- NCT01856491
- Testing
- RELIANCE 4-FRONT™ Passive Fixation lead implantation
- Where
- 11 sites in Germany, Israel and 1 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation