Clinical trials: Pacemaker Complication
Pacemakers, Defibrillators
Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access (CEPHAX)
This clinical trial evaluates the efficacy and safety of axillary versus cephalic venous access in the pacemakers and defibrillators implantation.
- Conditions
- Pacemakers, Defibrillators, Complication, Pacemaker Electrode Lead Fracture
- Trial name
- CEPHAX (NCT03860090)
- Testing
- Pacemaker implant, Defibrillator implant, AXILLARY VEIN ACCESS
- Where
- Spain
- Volunteers
- 240 people
- Sponsor
- Castilla-La Mancha Health Service
Pacemaker, Defibrillators, Implantable
Complications Following Pacemaker or Implantable Defibrillator Cardioverter (ICD) Implantation in Denmark
This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD) implantation.
- Trial name
- NCT01138670
- Where
- Denmark
- Volunteers
- 5,500 people
- Sponsor
- University of Aarhus
Pacemaker Lead Dysfunction
Complications of a Stepwise Approach for Transvenous Lead Extraction
It is an observational study of predictors of complications and difficulty of trans-venous lead extraction procedure. This procedure is done for patient who had a previous cardiac pacemaker or defibrillator implantation which had…
- Trial name
- NCT04306575
- Testing
- Trans-venous lead extraction
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Assiut University
Left Ventricular Dysfunction, Heart Failure, Systolic
Reprogramming to Prevent Progressive Pacemaker-induced Remodelling
The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.
- Conditions
- Left Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure, Pacemaker; Complication, Mechanical
- Trial name
- PPPR (NCT03627585)
- Testing
- Personalised programming
- Where
- 2 sites in United Kingdom
- Volunteers
- 91 people
- Sponsor
- University of Leeds
Leadless Pacemaker
Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication
Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in select patients. Advances in battery and electronics technology allow for the entire pacemaker system to be implanted into the right…
- Trial name
- NCT06692218
- Testing
- Leadless pacemaker
- Where
- Hong Kong
- Volunteers
- 196 people
- Sponsor
- Chinese University of Hong Kong
Arrhythmias, Cardiac, Venous Puncture
Ultrasound Guided Axillary Access vs Standard Fluoroscopic Technique for Cardiac Lead Implantation: ZEROFLUOROAXI TRIAL
Single center, randomized trial (1:1 fashion) to asses the safety and the feasibility of the ultrasound guided venous puncture vs standard fluoroscopic technique in patients undergoing pacemaker or implantable…
- Conditions
- Arrhythmias, Cardiac, Venous Puncture, Implantable Defibrillator User, Pacemaker Complication
- Trial name
- ZEROFLUOROAXI (NCT05101720)
- Testing
- Ultrasound Guided Axillary Venous Access, Fluoroscopy-Guided Axillary Venous Access
- Where
- Italy
- Volunteers
- 280 people
- Sponsor
- University Hospital of Ferrara
Prosthesis-Related Infections, Equipment Failure
Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers
The growing use and the expanding indications for cardiovascular implantable electronic devices (CIEDs) have been associated to an increase of device removal.
- Conditions
- Prosthesis-Related Infections, Equipment Failure, Heart Failure, Arrhythmias
- Trial name
- GAINE LASER (NCT03121183)
- Testing
- Laser sheath, Implantable Cardiac Device lead extraction
- Where
- France
- Volunteers
- 45 people
- Sponsor
- University Hospital, Clermont-Ferrand
Cardiac Valve Disease, Aortic Valve Stenosis
Remote ECG Monitoring of TAVI Patients
After surgery, patients who undergo transcatheter aortic valve implantation (TAVI) are at risk of developing cardiac arrhythmias such as heart blocks and atrial fibrillation.
- Trial name
- NCT03810820
- Testing
- mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)
- Where
- Canada
- Volunteers
- 240 people
- Sponsor
- Population Health Research Institute
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
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
Bradyarrhythmias, AV Block Complete
Belgo-Luxembourg Leadless PM Registry
This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott.
- Conditions
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1, Pacemaker
- Trial name
- BELLA (NCT07879716)
- Testing
- CT scan heart, 24 hour ambulatory ECG monitoring
- Where
- 9 sites in Belgium, Luxembourg
- Volunteers
- 190 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Heart Failure, Pacemaker-Induced Cardiomyopathy
The PICM Risk Prediction Study - Application of AI to Pacing
Development of pacing induced cardiomyopathy (PICM) is correlated to a high morbidity as signified by an increase in heart failure admissions and mortality.
- Conditions
- Heart Failure, Pacemaker-Induced Cardiomyopathy, Pacemaker Complication
- Trial name
- NCT06449079
- Testing
- Machine learning
- Where
- 3 sites in United Kingdom
- Volunteers
- 10,000 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Preterm Birth
Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions
Use an electrical-inhibition (EI)/uterine pacemaker device similar to an electrical heart pacemaker to deliver a weak electrical current to the human uterus that will rapidly and safely inhibit the unwanted premature uterine…
- Trial name
- NCT00212446
- Testing
- Electrical Intervention (EI)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- St. Luke's-Roosevelt Hospital Center
Tunisian Patients Already Implanted With a TAVI
Tunisian Registry of Trans Catheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement.
- Trial name
- TAVI-TN (NCT06503965)
- Where
- Tunisia
- Volunteers
- 300 people
- Sponsor
- Les Laboratoires des Médicaments Stériles
Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System
Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
- Conditions
- Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System, Venous Occlusion
- Trial name
- NCT02331511
- Testing
- Aspirin 80 mg daily, Clopidogrel 75 mg daily
- Where
- Iran
- Volunteers
- 100 people
- Sponsor
- Shahid Beheshti University of Medical Sciences
Pacemaker, Leadless Pacemaker
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
The registry for leadless pacemakers will collect and annually analyze the data of all leadless pacemaker implantations at the University Hospital St.
- Conditions
- Pacemaker, Leadless Pacemaker, Cardiac Pacing, Artificial, Registries
- Trial name
- LPR (NCT07246135)
- Where
- Austria
- Volunteers
- 700 people
- Sponsor
- Karl Landsteiner University of Health Sciences
Bradyarrhythmias
Outcome of Patients Undergoing Leadless Pacemaker Implantaton
Observational study aimed to evaluate the rate and of complications related to lealdless pacemaker implantation.
- Trial name
- OPUPI (NCT06656468)
- Testing
- Pacemaker and defibrillator
- Where
- Italy
- Volunteers
- 900 people
- Sponsor
- Azienda Ospedaliera Cardinale G. Panico
Cardiac Pacing, Permanent Pacemaker Implantation
Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation
This single-center, prospective, randomized, controlled clinical trial aims to evaluate whether ultrasound-guided PECS II block, when added to standard local infiltration anesthesia, improves perioperative analgesia in patients…
- Conditions
- Cardiac Pacing, Permanent Pacemaker Implantation, Postoperative Pain
- Trial name
- PACE-PECS (NCT07739407)
- Testing
- Ultrasound-Guided PECS II Block, Standard Local Infiltration Anesthesia
- Volunteers
- 72 people
- Sponsor
- ferdi gülaştı
Bradyarrhythmias, Arrhythmias
Thromboembolic Complications After Pacemaker or Implantable Cardioverter-Defibrillator Procedures
This is a large prospective registry of patients submitted to cardiac electronic devices implantation designed to investigate the incidence, risk factors and prognostic of thromboembolic complications associated with transvenous…
- Conditions
- Bradyarrhythmias, Arrhythmias, Cardiovascular Disease, Venous Thrombosis
- Trial name
- NCT01717495
- Where
- Brazil
- Volunteers
- 1 people
- Sponsor
- University of Sao Paulo
Device Related Infection, Device Malfunction
Project My Heart Your Heart: Pacemaker Reuse
Lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in Low and Middle Income Countries (LMIC).
- Conditions
- Device Related Infection, Device Malfunction, Bradycardia
- Trial name
- MHYH (NCT04016870)
- Testing
- Reconditioned Pacemaker, New Pacemaker
- Where
- 8 sites in Kenya, Mexico and 5 more
- Volunteers
- 370 people
- Sponsor
- University of Michigan