Clinical trials: Pacemaker Implantation
Postoperative Care After Cardiac Implantable Electronic Device Implantation
Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement
This randomized controlled trial will evaluate the effects of short-term medical arm sling use during the first 24 hours after cardiac implantable electronic device (CIED) implantation on patient comfort, pain, satisfaction, and…
- Trial name
- CIED-SLING24 (NCT07810426)
- Testing
- Medical Arm Sling
- Volunteers
- 104 people
- Sponsor
- Tugba Yorulmaz
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
Complication of Surgical Procedure, Pacemaker Complication
Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis
To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.
- Conditions
- Complication of Surgical Procedure, Pacemaker Complication, Pacemaker Syndrome
- Trial name
- NCT05761821
- Testing
- Leadless pacemaker
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Pacemaker Implantation for Sinus Node Disease
Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing
Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators. The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular…
- Trial name
- ADVANTAGE (NCT01803217)
- Testing
- pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Arrhythmia
Radiation-free Anatomical Direct Imaging Approach for No-fluoroscopy Cardiac Electrode Implantation
Permanent pacemaker implantation is traditionally performed under fluoroscopic (X-ray) guidance. Although effective, fluoroscopy exposes patients and medical staff to ionizing radiation.
- Trial name
- RADIANCE (NCT07458724)
- Testing
- Permanent Pacemaker Implantation
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Sick Sinus Syndrome, Complete Atrioventricular Block
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing single-chamber pacemaker implantation.
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block, Bradycardia
- Trial name
- ZF-PMSC (NCT03118440)
- Testing
- zero-fluoroscopy 3D navigation, conventional x-ray navigation
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital
Pacemaker Complication, Mobilization
Early Mobilization After Pacemaker Implantation.
Permanent pacemaker implantation is one of the most common arrhythmological procedure. This procedure is usually accompanied by a minimum of 2-3 days hospitalization, with immobilization of patients (supine) for 16-24 hours.
- Trial name
- EMAPI (NCT04111354)
- Testing
- Pacemaker implantation
- Where
- Czechia
- Volunteers
- 200 people
- Sponsor
- Charles University, Czech Republic
Aortic Stenosis, Right Bundle-Branch Block
Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients…
- Trial name
- TAVI-PACE (NCT05889208)
- Testing
- Prophylactic pacemaker implantation
- Volunteers
- 320 people
- Sponsor
- Aalborg University Hospital
Analgesia After Pacemaker, AICDS Implantation Pediatrics
Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients
The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a…
- Trial name
- NCT04184349
- Testing
- LA group, B Group
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center, Houston
Anxiety, Pain
Impact of Virtual Reality on Anxiety and Pain During Implantation of Cardiac Implantable Electronic Devices (CIED)
Purpose: This study aimed to evaluate whether virtual reality technology positively affects patients' pain and anxiety throughout the entire procedure of implantation of cardiac pacemakers, defibrillators, or cardiac…
- Trial name
- CIED (NCT07250282)
- Testing
- Virtual reality headset
- Where
- Germany
- Volunteers
- 111 people
- Sponsor
- Muhammed Kurt
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
Heart Failure With Preserved Ejection Fraction
SHort Of Pace - Heart Failure (SHOP-HF)
This study is designed as a multicenter, prospective, controlled, randomized, two-arms, cross-over, two parallel cohorts, efficacy Clinical research with CE-marked medical device .
- Trial name
- NCT06992089
- Testing
- Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
First Time Dual Chamber Pacemaker Implantation
Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients
Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to heart failure. The investigators aim to test hypothesis that valsartan started immediately after dual chamber pacemaker implantation will…
- Trial name
- NCT01805804
- Where
- Poland
- Volunteers
- 88 people
- Sponsor
- Medical University of Silesia
Heart Failure
Implant of the WiSE CRT System With an Intracardiac Pacemaker
This study is a single arm, prospective, feasibility, multi-centre, observational study. Participants will be suitable for a Cardiac Resynchronisation Therapy (CRT) implant using Wireless Stimulation Endocardially for Cardiac…
- Trial name
- TLC (NCT05451797)
- Testing
- Implant of WiSE-CRT with intracardiac pacemaker
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Bradyarrhythmia
Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes
Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart.
- Trial name
- PACMAN (NCT01897558)
- Testing
- Pacemaker implantation
- Where
- 5 sites in Croatia, Germany and 1 more
- Volunteers
- 290 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Stenosis
Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation
Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery.
- Trial name
- TAVISTIM (NCT02337140)
- Testing
- Pacemaker SORIN Group KORA DR, transcatheter aortic valve implantation (TAVI)
- Where
- France
- Volunteers
- 165 people
- Sponsor
- University Hospital, Montpellier
Late Complication From Cardiac Pacemaker Implantation
Effects of Right Ventricular Pacemaker Lead Position Assessed by MRI
Chronic right ventricular apical pacing has been associated with negative hemodynamic effects. Clinical outcome of right ventricular pacing can be influenced by multiple factors.
- Trial name
- NCT01682239
- Testing
- RVAP, RVSP
- Where
- Austria
- Volunteers
- 24 people
- Sponsor
- Medical University of Vienna
Post Pacemaker Implantation Patients
Evaluation of Atrial Fibrillation Occurrence in Sick Sinus and Complete Atrioventricular Block Patients After Pacemaker Implantation (AF-pacemaker Study)
This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients post pacemaker implantation.
- Trial name
- NCT03303872
- Where
- South Korea
- Volunteers
- 900 people
- Sponsor
- Yonsei University
Sick Sinus Syndrome, Complete Atrioventricular Block
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing double-chamber pacemaker implantation.
- Conditions
- Sick Sinus Syndrome, Complete Atrioventricular Block, High Degree Second Degree Atrioventricular Block (Disorder), Bradycardia
- Trial name
- ZF-PMDC (NCT03118427)
- Testing
- zero-fluoroscopy 3D navigation, conventional x-ray navigation
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Tongji Hospital