Clinical trials: Permanent Pacemaker
Heart Block, Heart Failure
Right Apical Versus Septal Pacing Trial
The purpose of this study is to examine whether RV (right ventricular)septal pacing has any effect on LV ( left ventricular) function than RV apical pacing in patients who require ventricular pacing.
- Trial name
- RASP (NCT00199498)
- Testing
- Apical RV lead placement, Septal RV lead placement
- Where
- Canada
- Volunteers
- 160 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Atrial Fibrillation
The Role of hs Troponin I and NT-proBNP in Predicting Atrial Fibrillation in Patients With Permanent Pacemakers
The goal of this clinical trial is to answer the research question whether hs Troponin I and NT-proBNP have a role in detecting atrial fibrillation in patients with pacemakers. Objectives of the study: 1.
- Trial name
- NCT06174506
- Where
- Vietnam
- Volunteers
- 300 people
- Sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
Atrial Fibrillation, Permanent Atrial Fibrillation
Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial
The goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation…
- Conditions
- Atrial Fibrillation, Permanent Atrial Fibrillation, Persistent Atrial Fibrillation, Pacemaker DDD
- Trial name
- PACE-AF (NCT06377046)
- Testing
- Accelerated pacing, Current standard of care
- Volunteers
- 50 people
- Sponsor
- Maastricht University Medical Center
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
Cardiac Pacing Indication classI/IIa According AHA/ACC
Progressive Ventricular Dysfunction Prevention in Pacemaker Patients
The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in patients with ventricular dysfunction within the permanent pacing population.
- Trial name
- Prevent-HF (NCT00170326)
- Testing
- dual-chamber pacemaker implantation, biventricular dual-chamber pacemaker implant
- Where
- 5 sites in Spain
- Volunteers
- 108 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Syncope
Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope
Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.
- Trial name
- SYNCOPACED (NCT04229589)
- Testing
- Clinic follow-up
- Where
- 7 sites in Italy
- Volunteers
- 1,364 people
- Sponsor
- Azienda Ospedaliera Cardinale G. Panico
Sinus Node Dysfunction
Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only.
- Trial name
- SANOK (NCT05196126)
- Testing
- Permament pacemaker implantation, Cardioneuroablation
- Where
- 4 sites in Poland
- Volunteers
- 60 people
- Sponsor
- Stec, Sebastian, MD, PhD, FESC
Reflex Syncope
Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
Reflex syncope is the most common form of syncope. It can lead to injuries and affect quality of life. Nonpharmacological and medical therapies have limited effectiveness.
- Trial name
- PANACEA (NCT05855603)
- Testing
- Cardioneuroablation, Permanent pacemaker therapy
- Where
- 10 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
Aortic Aneurysm, Aortic Diseases
Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels
As potential biomarkers of pressure-related aortic damage, matrix metalloproteinases (MMP) have been implicated in the pathogenesis of aortic aneurysm because of the important role they play in connective tissue homeostasis.
- Conditions
- Aortic Aneurysm, Aortic Diseases, Pacemaker DDD
- Trial name
- NCT03727542
- Testing
- adjustment of atrioventricular delay in DDD packers
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Istanbul University
Bilateral Vocal Cord Paralysis
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without 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).
- Trial name
- NCT06007170
- Testing
- SPIRION Laryngeal Pacemaker System Implantation and follow-up
- Where
- 6 sites in Austria, Germany
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Atrial Fibrillation (AF), Heart Failure - NYHA II - IV
Cardiovascular Performance and Exercise Response in Patients With Persistent or Permanent Atrial Fibrillation and Heart Failure Pre and Post Cardioversion or Pace and Ablate
Heart Failure (HF) and Atrial Fibrillation (AF) are two conditions that commonly occur together. Clinical guidelines consider a resting heart rate of 100-110 beats per minute (bpm) acceptable for patients with HF and AF while 72…
- Conditions
- Atrial Fibrillation (AF), Heart Failure - NYHA II - IV, Pacemaker, Cardioversion
- Trial name
- CPEX-CPA (NCT07205679)
- Volunteers
- 40 people
- Sponsor
- Habib Khan
Aortic Valve Stenosis, AV Block
Edwards SAPIEN 3 PPI Registry
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct (NCT03497611)
- Testing
- transcatheter valve implantation
- Where
- 4 sites in Germany
- Volunteers
- 1,000 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
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
Symptomatic Aortic Valve Stenosis
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI
The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study.
- Trial name
- NCT01801098
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Persistent Atrial Fibrillation
Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation
Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.
- Trial name
- CAPAPAF-65 (NCT02528604)
- Testing
- Catheter ablation, Pacemaker and AV node ablation, DC Cardioversion
- Where
- 2 sites in United Kingdom
- Volunteers
- 75 people
- Sponsor
- East Sussex Healthcare NHS Trust
Pacemaker DDD
The Feasibility of Motivational Interviewing on Emotional Intelligence, Dispositional Optimism, and Adherence to Care Practices Among Patients With Permanent Pacemaker
A cardiac pacemaker is an artificial apparatus that stimulates the myocardium electrically to depolarize, to begin a contraction when the heart's natural pacemaker does not work properly.
- Trial name
- NCT05883514
- Testing
- Motivational interviewing
- Where
- Egypt
- Volunteers
- 70 people
- Sponsor
- Alexandria University
MRI
VAPORHCS/OHSU J: MRI and Devices
This is a database study of clinically indicated MRIs on patients with permanent pacemakers and implantable cardioverter defibrillators.
- Trial name
- NCT03915015
- Testing
- MRI
- Where
- 2 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- Oregon Health and Science University
Quality of Life, Pacemaker Ddd Permanent
Clinical Benefit of Rigourous AV Delay Optimization in Patients With a Dual Chamber Pacemaker
Though AV optimization has become a cornerstone in optimization of patients with a cardiac resynchronization therapy (CRT) device, surprisingly the use of AV optimization in patients with a dual chamber (bicameral (BIC))…
- Conditions
- Quality of Life, Pacemaker Ddd Permanent, Atrial Dysfunction
- Trial name
- CBRAVO (NCT01998256)
- Testing
- AV optimization
- Where
- Belgium
- Volunteers
- 28 people
- Sponsor
- Jessa Hospital
Fibrosis, Atrial Fibrillation
Myocardial Fibrosis in Patients With Permanent Pacemakers
Patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation will be included in the study.
- Conditions
- Fibrosis, Atrial Fibrillation, Atrial Flutter
- Trial name
- NCT05920226
- Testing
- pacemakers implantation and assessment of cardiac function and cardiac fibrosis, assessment of cardiac function and cardiac fibrosis
- Where
- Russia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Ryazan State Medical University
Pacemaker Complication
Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation
The insertion of a permanent pacemaker (PPM) is frequently a life-saving procedure. However, the implantation process could sometimes lead to a rare but serious infection.
- Trial name
- PACE-PRO (NCT06355115)
- Testing
- Cefazolin 1000 MG Injection
- Where
- Indonesia
- Volunteers
- 100 people
- Sponsor
- University of Brawijaya