Clinical trials: Pacemaker Implantation
Pacemaker, Defibrillators, Implantable
Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation
Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication.
- Trial name
- NCT06330675
- Testing
- Early mobilization, Standard of care
- Where
- Switzerland
- Volunteers
- 558 people
- Sponsor
- Caporali Elena
Congenital Heart Disease, Bradycardia Sinus
Specialized Pacing for Patients With Congenital Heart Disease
The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing…
- Trial name
- NCT03361189
- Testing
- Closed loop stimulation, Standard rate response
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, Los Angeles
Aortic Valve Disease, Transcatheter Aortic Valve Implantation
Rapid Atrial Pacing After TAVI to Predict Pacemaker Implantation
Despite Transcatheter aortic valve implantation (TAVI) evolution regarding techniques, equipment and experience, the need for permanent pacemaker implantation (PPI) post-TAVI remains an important drawback.
- Conditions
- Aortic Valve Disease, Transcatheter Aortic Valve Implantation, TAVI
- Trial name
- NCT06189976
- Testing
- Rapid atrial pacing
- Where
- 2 sites in Belgium, Greece
- Volunteers
- 400 people
- Sponsor
- National and Kapodistrian University of Athens
Aortic Valve Stenosis, Heart Failure
Conventional Versus Left Bundle Branch Pacing in TAVI
This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left…
- Conditions
- Aortic Valve Stenosis, Heart Failure, Pacemaker-Induced Cardiomyopathy, Transcatheter Aortic Valve Implantation
- Trial name
- NCT05895097
- Testing
- Left bundle branch pacemaker, Conventional pacing
- Where
- Slovenia
- Volunteers
- 50 people
- Sponsor
- University Medical Centre Ljubljana
Atrioventricular Block, Second and Third Degree
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic…
- Trial name
- PACE-4-TAVI (NCT05966675)
- Testing
- conduction system pacing, right ventricular or biventricular pacing
- Where
- Poland
- Volunteers
- 500 people
- Sponsor
- Medical University of Silesia
Right Ventricular Dysfunction
Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study
This study aims to understand how the right side of the heart changes in people who receive an implantable cardiac electronic device (CIED), such as a pacemaker, ICD, or CRT device.
- Trial name
- RIGHT-CIED (NCT07272395)
- Testing
- Multimodal Right Ventricular Evaluation
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Istanbul University - Cerrahpasa
Pacemaker DDD
Use of VR in Patients' Education Prior to Implantation of PPM
The aim of this study is to compare standard education with VR augmented education in patients prior to implantation of a permanent pacemaker.
- Trial name
- NCT05695534
- Testing
- VR educational video
- Volunteers
- 400 people
- Sponsor
- Adela Drozdova
Post-TAVI
Assessment of the Prognosis of Persistent Left Bundle Branch Block (LBBB)After Transcatheter Aortic Valve Implantation (TAVI ) by an Electrophysiological and Remote Monitoring Risk-adapted Algorithm
The replacement of the aortic valve by percutaneous approach (called TAVI) is a therapy which is booming in the management of aortic stenosis.
- Trial name
- LBBB-TAVI (NCT02482844)
- Testing
- pacemaker implantation, holter implantation
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Clermont-Ferrand
Pacemaker DDD, Cardiopulmonary Endurance
Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation
The purpose of this study is to observe the changes of cardiopulmonary endurance in patients with pacemaker implantation after long-term exercise, to explore the significance of exercise on patients with pacemaker implantation…
- Trial name
- NCT04957771
- Testing
- Supervise and guide regular exercise
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Peking University Third Hospital
Gastroparesis, Gastroparesis Postoperative
Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying.
- Conditions
- Gastroparesis, Gastroparesis Postoperative, Gastroparesis Nondiabetic, Gastroparesis With Diabetes Mellitus
- Trial name
- NCT06661668
- Testing
- Gastric pacemaker (Enterra system) implantation
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Evangelic Hospital Kalk Cologne
Bradycardia, Sudden Cardiac Arrest
Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant
The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through…
- Trial name
- NCT01809652
- Testing
- Remote Implant Support Capability
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bilateral Vocal Cord Paralysis
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients With Single-sided Glottal Enlargement
The goal of this clinical investigation is to learn about the use of a novel medical device, the SPIRION Laryngeal Pacemaker, in patients suffering from bilateral vocal fold paralysis (BVFP) and who have had at least one related…
- Trial name
- NCT06007144
- Testing
- SPIRION Laryngeal Pacemaker System Implantation and follow-up
- Where
- 6 sites in Austria, Germany
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
AV Block Complete, Tricuspid Regurgitation (TR)
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear.
- Trial name
- NCT06814574
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Pacemaker Implantation, AV Node Disease
Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration
This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States.
- Trial name
- COMPAREPACE (NCT06690333)
- Testing
- Pacemaker
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
Transcatheter Aortic Valve Replacement
Prognostic Factors in NOP-LBBB After TAVI
The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI).
- Trial name
- ProgNOP-LBBB (NCT05654792)
- Testing
- Transcatheter aortic valve implantation
- Volunteers
- 230 people
- Sponsor
- Central Hospital, Nancy, France
Quality of Life (QOL) and Impact of Stress
Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation
The project "Investigating Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation" aims to investigate the relationship between stress and the postoperative healing process…
- Trial name
- NCT07343466
- Testing
- Survey using a questionnaire.
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- University Hospital, Essen
Sinus Node Dysfunction, Sick Sinus Syndrome
Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction
Endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (VV), functional atrioventricular block (AVB) and sinus node dysfunction (SND) with a…
- Trial name
- DINERVAPACE (NCT05186220)
- Testing
- Cardioneuroablation, Permanent dual chamber pacemaker implantation
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Hospital Clinico Universitario de Santiago
Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation
A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR
Electrocardiogram (ECG)-based algorithms have been proposed to guide post-TAVI conduction management; however, their ability to predict clinically relevant delayed conduction disturbances remains limited.
- Conditions
- Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation, Right Bundle-Branch Block, Left Bundle-Branch Block
- Trial name
- LATETAVI (NCT07414485)
- Testing
- retrospective health data collection
- Where
- France
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Conduction Disorder, Pacemaker DDD
Comparative Study of the Surface Electrocardiogram Signals During the Implantation of Conduction System Pacing Devices
Introduction and objectives: Left bundle branch area pacing (LBBAP), is a novel modality of physiologic pacing that requires an adequate assessment of the endocardium as well as the body-surface electrocardiographic signals for a…
- Trial name
- NCT06371846
- Testing
- Selected signals from Pacing System Analyzers
- Where
- Spain
- Volunteers
- 78 people
- Sponsor
- Parc de Salut Mar
Atrial Fibrillation, Arrythmia
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- ABC (NCT05704426)
- Testing
- Impulse Dynamics Optimizer Device
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Hackensack Meridian Health