Clinical trials: Electrocardiogram, Valvular Heart Disease
Pacemaker, TAVI
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI).
- Conditions
- Pacemaker, TAVI, Risk Score
- Trial name
- TAVI PACER (NCT06542380)
- Testing
- TAVI, pacemaker
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- German Heart Institute
Aortic Stenosis, Diastolic Dysfunction
AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction
Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD).
- Trial name
- NCT06580158
- Testing
- AI-ECG Dashboard, Point of care ultrasound (POCUS)
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Mayo Clinic
Valvular Heart Disease Patients
The VALVE-AI Trial
The goal of this clinical trial is to learn if an artificial intelligence-powered electrocardiogram (AI-ECG) can help detect moderate or severe valvular heart diseases (VHD) in adults.
- Trial name
- NCT07023510
- Testing
- AI-ECG driven echocardiography
- Where
- Taiwan
- Volunteers
- 8,648 people
- Sponsor
- National Defense Medical Center, Taiwan
Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy Federated Learning Implementation Platform
HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning.
- Trial name
- HCM FLIP (NCT06461468)
- Where
- 6 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- American Heart Association
Atrial Fibrillation, Hypertension
Validation Study of an Advanced Blood Pressure Monitor
The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders.
- Conditions
- Atrial Fibrillation, Hypertension, Valvular Heart Disease
- Trial name
- TALISMAN (NCT04030494)
- Testing
- BP measurement, AF detection, VHD detection
- Where
- France
- Volunteers
- 218 people
- Sponsor
- Withings
Atrial Fibrillation, Cardiovascular Diseases
NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial
The goal of this clinical trial is to determine if a machine learning/artificial intelligence (AI)-based electrocardiogram (ECG) algorithm (rECHOmmend and ECG-AF) can identify undiagnosed cardiovascular disease in patients.
- Conditions
- Atrial Fibrillation, Cardiovascular Diseases, Arrhythmia, Valvular Disease
- Trial name
- NOTABLE (NCT06511505)
- Testing
- Risk-Based Assessment for Cardiac Dysfunction
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Valvular Heart Disease
Age and Sex-Specific PREValence of AcqUirEd VALVular Heart DiseasE
The PREVUE-VALVE study will establish reliable, population-based estimates of Valvular Heart Disease (VHD) prevalence among older Americans and allow for the development and validation of several innovative tools to aid in the…
- Trial name
- PREVUE-VALVE (NCT05357404)
- Where
- United States
- Volunteers
- 2,870 people, healthy volunteers welcome
- Sponsor
- Cardiovascular Research Foundation, New York
Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation
ECG and CXR for Predicting Cardiovascular Diseases
This retrospective multicenter cohort study aims to develop and validate an artificial intelligence model integrating electrocardiography (ECG) and chest radiography (CXR) to predict future progression of regurgitant valvular…
- Conditions
- Valvular Heart Diseases, Valvular Heart Disease Stenosis and Regurgitation, Regurgitation, Aortic Valve, Regurgitation, Mitral
- Trial name
- NCT07573852
- Where
- China
- Volunteers
- 116,380 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Electrocardiogram, Valvular Heart Disease
Artificial Intelligence-enhanced Electrocardiogram Diagnoses and Predicts Future Regurgitant Valvular Heart Diseases
This is a retrospective study to establish models for the prediction of future valvular heart diseases with artificial intelligence-enhanced electrocardiogram (ECG).
- Trial name
- NCT06475157
- Testing
- No intervention
- Where
- 2 sites in China, United Kingdom
- Volunteers
- 500,000 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Stenosis
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients…
- Trial name
- AoS-SEDAI (NCT07479992)
- Testing
- Willem AI ECG assessment
- Where
- 2 sites in Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Arterial Hypertension, Heart Rhythm Disorders
Screening for Cardiac and Cardiac-associated Pathology Using Single-channel Electrocardiogram
It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 4000 patients 18 years old and older in the training sample and 1000 patients over 18 years old in the…
- Conditions
- Arterial Hypertension, Heart Rhythm Disorders, Valvular Heart Diseases, Heart Failure
- Trial name
- NCT07396792
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Valvular Heart Disease Stenosis and Regurgitation, Valvular Heart Disease
Screening of Valvular Heart Disease Using Single-channel Electrocardiogram
It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 1000 patients over 18 years old in the training sample and 200 patients over 18 years old in the test…
- Trial name
- NCT07099417
- Testing
- No intervention (observational study)
- Where
- Russia
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Aortic Valve Stenosis, Mitral Regurgitation
Phono- and Electrocardiogram Assisted Detection of Valvular Disease
The diagnosis of valvular heart disease (VHD), or its absence, invariably requires cardiac imaging. A familiar and inexpensive tool to assist in the diagnosis or exclusion of significant VHD could both expedite access to…
- Conditions
- Aortic Valve Stenosis, Mitral Regurgitation, Heart Murmurs, Valvular Heart Disease
- Trial name
- PEA-Valve (NCT03458806)
- Testing
- AS Algorithm 1, AS Algorithm 2, MR Algorithm 1
- Where
- United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Cardiomyopathies, Amyloidosis Cardiac
Characterization of Patients With Cardiomyopathy to Identify Critical Patients Candidates for Cardiac Transplantation
The study aims to identify new diagnostic and prognostic markers for CMP that can help predict disease progression. In particular, the study will focus on microRNAs (miRNAs) and spatial transcriptomics, which are emerging…
- Conditions
- Cardiomyopathies, Amyloidosis Cardiac, Fabry Disease, Arrhythmogenic Cardiomyopathy
- Trial name
- CMPMIRNA (NCT06813443)
- Where
- 3 sites in Italy
- Volunteers
- 700 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
Prospective Evaluation of AI-ECG for SHD Detection
AI-ECG-SHD is a multicentre prospective observational diagnostic accuracy study evaluating artificial intelligence-enhanced electrocardiography (AI-ECG) for the detection of structural heart disease in adults undergoing…
- Conditions
- Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis), Heart Failure With Reduced Ejection Fraction (HFrEF; Diagnosis), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)
- Trial name
- AI-ECG-SHD (NCT07057466)
- Testing
- Traditional 12-lead Electrocardiogram, Apple Watch Series 4 Single-lead Electrocardiogram, Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram
- Where
- 6 sites in United Kingdom
- Volunteers
- 590 people
- Sponsor
- Imperial College London
Aortic Valve Stenosis, Cardiac Conduction Disturbance
Remote Cardiovascular Monitoring in Post-TAVI Patients
The goal of this randomised clinical trial is to utilise a remote monitoring algorithm to gather essential clinical data, aiming to guide the management of post-Transcatheter Aortic Valve Implantation (TAVI) patients and reduce…
- Conditions
- Aortic Valve Stenosis, Cardiac Conduction Disturbance, Digital Health, Transcatheter Aortic Valve Implantation
- Trial name
- TELE-TAVI (NCT06602609)
- Testing
- Remote Patient Monitoring Strategy, Standard Medical Therapy
- Where
- United Kingdom
- Volunteers
- 216 people
- Sponsor
- Imperial College London
Hypertrophic Cardiomyopathy
Diagnosis of HCM With AI-ECG
The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.
- Trial name
- NCT06287892
- Where
- China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Shanghai Zhongshan Hospital
Aortic Stenosis
ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been…
- Trial name
- NCT07827105
- Testing
- AK-AVS
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- AccurKardia, Inc.