Clinical trials: Heart Chambers
Atrial Fibrillation, Stroke
Philips Intracardiac Echocardiography (ICE) Clinical Registry
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT04950192
- Testing
- ICE Image guidance
- Where
- 5 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Atrial Septal Defect (ASD), Patent Foramen Ovale (PFO)
FIH Study With CBSO
The objective of this study is to evaluate the effectiveness and the safety of the intracardiac septal closure device (CBO), as well as the practicability of implantation of this device using the accessories (DS for CBO).
- Trial name
- NCT01960491
- Testing
- Device Closure of Atrial Septal Defect
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Carag AG
Heart Failure
Acorai Machine Learning Generalization (MLG) Study
Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and/or pulmonary hypertension, who require hemodynamic…
- Trial name
- CAPTURE-HF (NCT05835024)
- Testing
- Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1, Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 1,602 people, healthy volunteers welcome
- Sponsor
- Acorai AB
Cardiac Pacemaker, Arrythmia
AVEIR DR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05932602
- Testing
- Aveir DR Leadless Pacemaker System, Dual Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 2,812 people
- Sponsor
- Abbott Medical Devices
Heart Diseases, Arrhythmia, Cardiac
Evaluation of the LVivo Image Quality Scoring (IQS)
The study includes two parts: Part 1: 100 examinations of patient referred for echo evaluation, containing clips that were acquired from the 4CH apical view were collected retrospectively.
- Conditions
- Heart Diseases, Arrhythmia, Cardiac, Angina Pectoris, Unstable Angina
- Trial name
- NCT05563701
- Where
- Israel
- Volunteers
- 164 people
- Sponsor
- DiA Imaging Analysis Ltd
Cardiovascular Diseases, Arrhythmias, Cardiac
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
The ICE-ACCESS study is a prospective observational study designed to evaluate how procurement reliability, distribution restrictions, supply-chain interruptions, and device availability affect access to intracardiac…
- Conditions
- Cardiovascular Diseases, Arrhythmias, Cardiac, Atrial Fibrillation
- Trial name
- ICE-ACCESS (NCT07788040)
- Testing
- Intracardiac Echocardiography Catheter
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Truway Health, Inc.
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
Atrial Fibrillation, Deep Vein Thrombosis
Association Between Genetic Variant Scores and Warfarin Effect
Study objective is to determine whether there is an association between genetic variant risk scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥…
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Intracardiac Thrombus, Pulmonary Embolism
- Trial name
- AWARE1 (NCT03894878)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Cipherome, Inc.
Ventricular Tachycardia, Ventricular Fibrillation
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
- Trial name
- DATAS (NCT00157820)
- Testing
- Single Chamber Implantable Cardioverter Defibrillator, Dual Chamber implantable cardioverter defibrilator
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead.
- Trial name
- NCT00643279
- Testing
- Chronicle Implantable Hemodynamic Monitor, Standard of Care
- Where
- 28 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for synchronous bi-ventricular stimulation leads to…
- Trial name
- BIODetectHFII (NCT01711281)
- Testing
- Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
- Where
- 22 sites in Denmark, Germany and 3 more
- Volunteers
- 68 people
- Sponsor
- Biotronik SE & Co. KG
Bradycardia
Assessment of Intracardiac Electrograms Transmitted by Home Monitoring for the Remote Follow-up of Pacemaker (PREMS)
The purpose of the PREMS study is to evaluate the capability of the periodic IEGM feature (intracardiac electrogram) to provide more extensive remote information about cardiac rhythm, sensing and capture, and thus to detect…
- Trial name
- PREMS (NCT02174484)
- Where
- 49 sites in France
- Volunteers
- 571 people
- Sponsor
- Biotronik SE & Co. KG
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter
The purpose of this study is to assess the performance and safety of using the investigational catheter.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- NCT05970120
- Testing
- NUVISION NAV Ultrasound Catheter
- Where
- 3 sites in Croatia, Israel and 1 more
- Volunteers
- 30 people
- Sponsor
- Biosense Webster, Inc.
Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection
Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection
- Trial name
- PREVENT-DX (NCT04344704)
- Testing
- Single chamber DAI device with floating atrial dipole
- Where
- 16 sites in Spain
- Volunteers
- 462 people
- Sponsor
- Trialance SCCL
AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia
Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia
ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study.
- Conditions
- AtrioVentricular Nodal Reentrant Tachycardia, Supraventricular Tachycardia, Heart Disease
- Trial name
- NCT01426425
- Testing
- Freezor Xtra Cryoablation Catheter
- Where
- 34 sites in United States, Canada
- Volunteers
- 572 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Cardiac Arrhythmias
ViewFlex X ICE First-in-Human Study
This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data…
- Trial name
- ViewFlex X FIH (NCT06772493)
- Testing
- ViewFlex X ICE System
- Where
- 8 sites in United States
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Ventricular Tachycardia, Atrial Fibrillation
AVAI: Atrial Ventricular Arrythmia Incidence
The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.
- Trial name
- AVAI (NCT00832975)
- Where
- 2 sites in Spain
- Volunteers
- 157 people
- Sponsor
- Abbott Medical Devices
Arrhythmia, Sinus
EnTRINSIC - EnPulse Trial on Search AV+ Influence
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction.
- Trial name
- NCT00157794
- Testing
- Search AV+ algorithm
- Where
- 14 sites in Germany
- Volunteers
- 135 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmias, Cardiac
Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.
- Trial name
- SAFE-DX-Home (NCT04869527)
- Testing
- BIOTRONIK ICDs with DX Technology
- Where
- 2 sites in Brazil
- Volunteers
- 56 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