Clinical trials: Cardiac Pacemaker, open to volunteers
Cardiac Pacemaker Malfunction, ICD Malfunction
Perioperative Management Evaluation in Patients With CIED
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
- Conditions
- Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication
- Trial name
- EVINCE (NCT04331249)
- Testing
- surgery or catheter based cardiac procedure (catheter ablation)
- Where
- 2 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Klinikum-Fuerth
Arrhythmia, Cardiac
Japanese Lead Extraction Registry
Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center.
- Trial name
- J-LEX (NCT04345627)
- Where
- Japan
- Volunteers
- 5,000 people
- Sponsor
- National Cerebral and Cardiovascular Center, Japan
Brady-tachy Syndrome, Brady Arrythmia
ALPs Single ChambEr New Device Study
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Brady-tachy Syndrome, Brady Arrythmia, Bradycardia, AV Block
- Trial name
- ASCEND (NCT07469579)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 15 people
- Sponsor
- Cairdac SA
Atrial Fibrillation, Pacemaker Ddd
Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Atrial fibrillation (AF) is associated with a five-fold increased risk of cerebrovascular stroke. While the risk of stroke in patients with known AF can be calculated via AF stroke prediction risk scores, the prediction of AF…
- Conditions
- Atrial Fibrillation, Pacemaker Ddd, ICD
- Trial name
- SAFE-ME (NCT03357926)
- Testing
- 24 hour Holter ECG Monitoring
- Where
- Austria
- Volunteers
- 250 people
- Sponsor
- Medical University of Graz
Tricuspid Regurgitation, Pacemaker Complication
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only.
- Trial name
- PLACE (NCT05667519)
- Testing
- Additional guidance of lead implantation by transesophageal echocardiography
- Where
- Germany
- Volunteers
- 324 people
- Sponsor
- LMU Klinikum
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
Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and…
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree, Heart Failure
- Trial name
- CIED-CARE (NCT06652750)
- Testing
- Routine Management, 5G Cloud Follow-up
- Where
- 2 sites in China
- Volunteers
- 688 people
- Sponsor
- The Third People's Hospital of Chengdu
Atrial Fibrillation
Predicting Development of SCAF in Device Patients
Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that are only detected by implanted pacemakers or defibrillators. Usually people don't know that they have these episodes.
- Trial name
- NCT02808260
- Where
- Canada
- Volunteers
- 500 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Bradyarrhythmias, Heart Failure
Clinical Study of Impact of Different Pacing Site in Patients
At present, cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients.
- Conditions
- Bradyarrhythmias, Heart Failure, Pacemaker
- Trial name
- NCT04931550
- Testing
- Pacemaker implantation
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Atrial Arrhythmia, Atrial Fibrillation (AF)
Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.
This prospective observational study evaluates the burden of Atrial High-Rate Episodes (AHRE) in patients without a prior history of atrial fibrillation who undergo concurrent Bachmann Bundle Area Pacing (BBAP) and Left Bundle…
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation (AF), Pacemaker Implantation, Left Bundle Branch Pacing
- Trial name
- AHRE-BLAST (NCT07305194)
- Where
- Greece
- Volunteers
- 460 people
- Sponsor
- University Hospital of Patras
Pacemaker DDD, Heart Block
Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF).
- Trial name
- NCT05015660
- Testing
- Left bundle branch pacing lead, Right ventricular active fixation lead
- Where
- Canada
- Volunteers
- 1,300 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Tricuspid Regurgitation, CIED Implantation
3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device
The goal of this observational study is to learn about the development and worsening of tricuspid regurgitation (TR) in patients who have cardiac implantable electronic devices (CIEDs).
- Conditions
- Tricuspid Regurgitation, CIED Implantation, Leadless Pacemaker, Pacemaker
- Trial name
- 3DECHO-TR (NCT07793916)
- Testing
- 3D Transthoracic echocardiographic evaluation
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Samsung Medical Center
Sick Sinus Syndrome, Atrioventricular Nodal Dysfunction
Left Bundle Branch Versus Minimized Ventricular Pacing in Patients With Sick Sinus Syndrome and Prolonged AV Interval
The goal of this clinical trial is to compare two pacemaker strategies: Left Bundle Branch Area Pacing (LBBAP) and Minimized Ventricular Pacing (MVP) in patients requiring a permanent pacemaker for sick sinus syndrome and…
- Trial name
- CLOSE-AV (NCT07314008)
- Testing
- LBBAP, MVP
- Where
- South Korea
- Volunteers
- 440 people
- Sponsor
- Asan Medical Center
Pacemakers, MRI Imaging
The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups
SUMMARY OF THE CLINICAL PROTOCOL Background: The risks of Magnetic Resonance Imaging (MRI) at 1.5-tesla for patients with a non-MRI-conditional (NMRC) pacemaker have been documented, guidelines for clinical practice have been…
- Conditions
- Pacemakers, MRI Imaging, Implantable Cardioverter Defibrillator (ICD)
- Trial name
- NCT07189728
- Testing
- MRI
- Volunteers
- 1,500 people
- Sponsor
- The Scripps Research Institute
Sinus Pause, Sinus Sick Syndrome
Multimodality Location Prediction Accuracy of Leadless Pacemaker Positioning
One of the most serious complications with leadless pacemaker (LP) implants is right ventricle (RV) perforation. Understanding the accuracy of fluoroscopic guidance of implants compared to transthoracic echocardiograms (TTE) and…
- Conditions
- Sinus Pause, Sinus Sick Syndrome, Heart Block, Arrhythmias, Cardiac
- Trial name
- MAP (NCT07908927)
- Testing
- Cardiac Imaging by TTE or CTA
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sinus Node Disease, Atrioventricular; Block, Second Degree (Types I and II)
Physiological Ventricular Pacing Vs Managed Ventricular Pacing for Persistent AF Prevention in Prolonged AV Interval
A multicenter, prospective, randomized study in a 1:1 ratio, single-blind with double-blind evaluation to evaluate the superiority of physiological ventricular pacing (proposed modality) vs.
- Trial name
- PhysioVP-AF (NCT05367037)
- Testing
- PhysioVP, DDD-VPA
- Where
- Italy
- Volunteers
- 640 people
- Sponsor
- Quovadis Associazione
Arrhythmia, Cardiac Implantable Electronic Device
Virtual Reality in Electrophysiological Procedures and Device Implantation: the VR inEP Trial
Each year about 37,000 patients undergo a catheter ablation to treat cardiac arrhythmias or have a cardiac device such as a pacemaker or implantable cardioverter defibrillator implanted in the Netherlands.
- Conditions
- Arrhythmia, Cardiac Implantable Electronic Device, Ablation of Arrhythmias, Electrophysiologic Study
- Trial name
- VR inEP (NCT07105241)
- Testing
- VR therapy, 360 degree education videos
- Volunteers
- 115 people
- Sponsor
- Radboud University Medical Center
Vasovagal Syncope
Assessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates
The investigators will seek to determine the effects of different heart rates on both stroke volume and cardiac output using non-invasive hemodynamic assessments.
- Trial name
- Pacing_SV (NCT03446326)
- Testing
- Pacing
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- University of Calgary
Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome
Inappropriate Sinus Tachycardia Registry
The primary objective of this registry is to capture real-world safety and performance data on AtriCure devices used to ablate cardiac tissue when treating Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome…
- Trial name
- NCT05107635
- Testing
- AtriCure Commercially Available Devices
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 500 people
- Sponsor
- AtriCure, Inc.
Bradycardia, Brady-tachy Syndrome
ALPs Single ChambEr New Device
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Bradycardia, Brady-tachy Syndrome, AV Block, Atrial Fibrillation (AF)
- Trial name
- ASCEND (NCT07461935)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 10 people
- Sponsor
- Cairdac SA