Clinical trials: Conduction Defect, Cardiac
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
BIO|MASTER.CSP Study
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Ejection Fraction, LVF
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF)…
- Conditions
- Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement
- Trial name
- EFACT (NCT06699056)
- Testing
- 15-minutes of sitting during COR ECG Acquistion
- Where
- 8 sites in United States
- Volunteers
- 2,000 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.
Conduction Defect
Subcostal Temporary Extravascular Pacing V Study
The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System…
- Trial name
- STEP V (NCT05633394)
- Testing
- AtaCor StealthTrac Lead
- Where
- Paraguay
- Volunteers
- 29 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
Subcostal Temporary Extravascular Pacing IV (STEP IV) Study
The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV…
- Trial name
- STEP IV (NCT05457673)
- Testing
- AtaCor StealthTrac Lead
- Where
- Paraguay
- Volunteers
- 12 people
- Sponsor
- AtaCor Medical, Inc.
Conduction Defect
AtaCor Subcostal Temporary Extravascular Pacing III Study
Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System.
- Trial name
- STEP III (NCT04538287)
- Testing
- AtaCor StealthTrac Lead
- Where
- 4 sites in Czechia, New Zealand and 1 more
- Volunteers
- 33 people
- Sponsor
- AtaCor Medical, Inc.
Conduction Defect
Subcostal Temporary Extracardiac Pacing II Study
Up to 12 subjects will be enrolled (up to 8 undergoing an AtaCor Temporary Pacing System procedure) in order to evaluate initial safety and performance of the AtaCor Temporary Pacing System when used with three (3) strategies for…
- Trial name
- STEP II (NCT04374929)
- Testing
- StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy, StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid, Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing)
- Where
- 2 sites in New Zealand, Paraguay
- Volunteers
- 7 people
- Sponsor
- AtaCor Medical, Inc.
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.
Atrial Fibrillation, Premature Atrial and Ventricular Beats
A Study to Determine the Feasibility of Wireless Electrocardiography
The investigators are conducting a prospective, observational study to examine the ECG waveforms captured by the new medical device as compared to a traditional Holter monitor for subsequent use in visual diagnoses of atrial and…
- Conditions
- Atrial Fibrillation, Premature Atrial and Ventricular Beats, Conduction Defects, Normal Sinus Rhythm
- Trial name
- NCT02162394
- Testing
- Observational ambulatory ECG monitoring
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Peerbridge Health, Inc