Clinical trials: Pacemaker
Indications for VVI(R) Pacemaker
The LEADLESS Observational Study
The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.
- Trial name
- NCT02051972
- Testing
- Implanted with a Nanostim leadless pacemaker system
- Where
- 32 sites in Czechia, France and 5 more
- Volunteers
- 491 people
- Sponsor
- Abbott Medical Devices
Congenital Disorder
Pacemaker Therapy in Adults With Congenital Heart Defects
Review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications
- Trial name
- NCT00303511
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Emory University
Aortic Stenosis, Disorder of Prosthetic Cardiac Valve
Biomarkers in Aortic Stenosis - B.A.S.S.
This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart…
- Conditions
- Aortic Stenosis, Disorder of Prosthetic Cardiac Valve, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- BASS (NCT01334801)
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Conduction Disturbance, Trans Aortic Valve Implantation (TAVI)
Pre TAVI Membranous Septum Measurement Predicts High Grade Iatrioventricular Conduction Disorders in Patients With Specific Pacemaker Implanted After TAVI. The STIM TAVI-MS Study
Conduction disturbances are a major complication of TAVI. There is no predictor of post-TAVI conduction disorder. The study of the membranous septum on the pre-TAVI scanner and the valve implantation height are promising and…
- Trial name
- STIM TAVI MS (NCT04906837)
- Testing
- Trans aortic valve implantation
- Where
- France
- Volunteers
- 197 people
- Sponsor
- Association de Recherche en Cardiologie des Alpes
Device:MRI
Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators
Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns.
- Trial name
- NCT02888353
- Testing
- Device: MRI
- Where
- United States
- Volunteers
- 4,500 people
- Sponsor
- Johns Hopkins University
Cardiovascular Disease
Economic Evaluation in Cardiology: Remote Monitoring of Pacemakers
The purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers. The initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of…
- Trial name
- NCT02234245
- Testing
- Telemedicine System
- Where
- Spain
- Volunteers
- 83 people
- Sponsor
- Universidad de Almeria
Atrial Fibrillation
FFS - Far Field Sensing Test Study in Cardiac Dual Chamber Pacemakers
The purpose of this study is to evaluate the effect of individual adjustment of the postventricular atrial blanking period in avoiding inappropriate mode switch of dual chamber pacemakers.
- Trial name
- NCT00196144
- Testing
- Individualized Programming of PVAB, Nominal PVAB
- Where
- Germany
- Volunteers
- 207 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
The PEP-HFpEF study is a prospective, single-center mechanistic study evaluating personalized heart rate pacing (myPACE) in patients with heart failure with preserved ejection fraction (HFpEF) and existing cardiac physiologic…
- Conditions
- Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III, Heart Failure New York Heart Association (NYHA) Class II
- Trial name
- NCT07864558
- Testing
- Individualized myPACE pacemaker programming
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Tufts Medical Center
Bradycardia
Falls and Cardiovascular Events in Pacemaker Patients
The purpose of this study is to document the number of falls and fractures in Sinus Node Disease (SND) patients.
- Trial name
- NCT01037426
- Testing
- Fill out Questionnaire
- Where
- 8 sites in Switzerland
- Volunteers
- 87 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Pacemaker, Implantable Cardioverter Defibrillator
Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator Recipients
The purpose of the registry is to evaluate an organizational model fixing roles and behaviors of subjects involved in the remote monitoring of patients implanted with pacemakers and defibrillators.
- Trial name
- NCT01459874
- Testing
- Organizational model for remote monitoring
- Where
- 74 sites in Italy
- Volunteers
- 1,650 people
- Sponsor
- San Filippo Neri General Hospital
Intracardiac Thrombus, Intracardiac Mass
AngioVac Aspiration Therapy Registry
As a structured, multinational retrospective registry the AVATAR Registry addresses the following scientific aspects through systematic data collection, centralized quality control, and robust statistical analysis in patients…
- Conditions
- Intracardiac Thrombus, Intracardiac Mass, Intravascular Thrombosis, Vegetation; Heart
- Trial name
- AVATaR (NCT07769320)
- Testing
- Retrospective analysis of assigned treatment
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- Charite University, Berlin, Germany
Cardiac Pacemaker, Arrhythmias, Cardiac
The Leadless AV Versus DDD Pacing Study
Cardiac pacemaker (PM) implantation is the established treatment for relevant bradyarrhythmias. Conventional PMs require 1-3 pacing leads to register the heart's intrinsic activity ("sensing") and to deliver the electrical…
- Conditions
- Cardiac Pacemaker, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
- Trial name
- LEAVE DDD (NCT05498376)
- Testing
- Conventional pacemaker DDD, Leadless pacemaker Micra AV
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Bradycardia, Syncope
Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.
Background Sinus node dysfunction (SND) and atrioventricular block (AVB) are significant diagnostic and therapeutic problems. The primary method of their treatment is cardiac pacemaker implantation (PM).
- Trial name
- GENTLE-PACE (NCT05896592)
- Testing
- Invasive electrophysiological study, Extracardiac vagal stimulation, Cardioneuroablation
- Where
- 2 sites in Poland
- Volunteers
- 99 people
- Sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland
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
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
Conduction Block, Atrioventricular, Bundle-Branch Block
Novel Approach to Conduction System Pacing With Use of Ultrasound
Each year, over one million pacemakers are implanted globally using x-rays. Recent developments have been aimed at determining which area of the heart is the best option for lead placement.
- Trial name
- CONDUCT USe (NCT06815783)
- Testing
- Ultrasound guidance, Fluoroscopy guided
- Where
- 2 sites in Canada
- Volunteers
- 152 people
- Sponsor
- Habib Khan
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
Atrial Fibrillation
ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation
Randomised crossover study comparing the sensitivity and specificity of 5 External loop recorders in detecting pacemaker detected Atrial fibrillation burden.
- Trial name
- REMAP-AF (NCT02506621)
- Testing
- R test, Nuubo, TECHNOMED pocket ECG
- Volunteers
- 20 people
- Sponsor
- East Sussex Healthcare NHS Trust
Hypertrophic Cardiomyopathy
Biventricular Pacing in Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy is an inherited condition characterized by thickening (hypertrophy) of the heart muscle. Many patients who have this condition have a reduced ability to exercise because of breatlessness, which can in…
- Trial name
- NCT00504647
- Testing
- Biventricular Pacemaker
- Where
- 3 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- University Hospital Birmingham
Bradycardia
SITELINE 2 Polyurethane
The SITELINE 2 Polyurethane Clinical Investigation analyzed the safety and electrical performance of the SITELINE 2 Polyurethane pacing lead.
- Trial name
- NCT00180284
- Testing
- SITELINE 2 Polyurethane (pacing lead)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation