Clinical trials: Pacemaker, open to volunteers
Cardiovascular Diseases, Arrhythmias, Cardiac
Multicenter Evaluation of Patients Using LATITUDE Monitoring System
The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.
- Conditions
- Cardiovascular Diseases, Arrhythmias, Cardiac, Heart Failure, Sudden Cardiac Death
- Trial name
- Multitude (NCT06311149)
- Where
- 3 sites in Italy
- Volunteers
- 20,000 people
- Sponsor
- University Hospital of Ferrara
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
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
Patient Safety
An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans
This study will evaluate if an intervention using academic detailing and audit and feedback impacts the specific pacemaker or implantable cardioverter-defibrillator (ICD) lead models implanted in Veterans.
- Trial name
- Veteran CIEDs (NCT05062434)
- Testing
- Academic detailing and audit and feedback intervention
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- VA Office of Research and Development
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
Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment…
- Conditions
- Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation, Right Ventricular Dysfunction
- Trial name
- LvL-PACE (NCT07534917)
- Testing
- Temporary left bundle branch area pacing, Temporary leadless right ventricular pacing
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Atrioventricular Synchrony by the Micra AV
French Cohort Evaluating the effectiveneSs of Atrioventricular Synchrony by the micRa AV
Transvenous cardiac pacemakers have pitfalls due to lead- and device pocket-related complications. Leadless pacemakers were developed and introduced into clinical practice to overcome the weaknesses of traditional transvenous…
- Trial name
- AV-CESAR (NCT05953558)
- Testing
- Patients implanted with Micra AV
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Paris Sudden Death Expertise Center
Bradycardia
Pacemaker-based Long-term Monitoring of Sleep Apnea
This is a prospective, non-interventional cohort study. It tests the hypothesis that Pacemaker-derived monitoring of sleep-related breathing disorders and/or daily physical activity predicts clinical outcome.
- Trial name
- ACaSA (NCT05127720)
- Where
- Austria
- Volunteers
- 1,000 people
- Sponsor
- Medical University Innsbruck
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 333 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
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
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
Leadless Pacemaker, Same-day Discharge
Vascular Access for Minimally-invasive Leadless Pacemaker Implantation Through the Right Jugular routE
Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g.
- Trial name
- VAMPIRE (NCT06455566)
- Testing
- Leadless pacemaker implantation through right internal jugular vein
- Where
- 13 sites in France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Caen
Scapular Dyskinesis, Posterior Shoulder Instability
Shoulder Pacemaker for Scapular Dyskinesia
The investigators purpose of this study is to determine patients-reported outcomes (VAS pain scores) in patients with Scapular Dyskinesis or Posterior Shoulder Instability who undergo rehabilitation with a shoulder pacemaker.
- Trial name
- NCT05116722
- Testing
- Shoulder Pacemaker
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Utah
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
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
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
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
Atrial Fibrillation, Atrial Septal Defect
Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach (Eight-Clover)
The purpose of this study is to evaluate the clinical efficacy and safety of the Perclose ProStyle™ Suture-Mediated Closure Device in patients undergoing cardiologic procedures via a femoral vein approach using a sheath size of 8…
- Conditions
- Atrial Fibrillation, Atrial Septal Defect, Vascular Closure Device
- Trial name
- Eight-CLOVER (NCT07827287)
- Testing
- Perclose ProStyle™ Suture-Mediated Closure System, Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Ewha Womans University Mokdong Hospital
Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines
AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of…
- Trial name
- NCT06782152
- Volunteers
- 1,698 people
- Sponsor
- King Fahad Armed Forces Hospital
Leadless Pacemaker
Aveir Leadless Pacemaker Japan PMS
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing.
- Trial name
- NCT07106788
- Testing
- Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients, Upgrades
- Where
- 14 sites in Japan
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices