Clinical trials: Pacemaker Therapy
Ischemic Mitral Regurgitation
Effect of Ranolazine on Valvular Disease in Patients With Pacemakers
The purpose of this study is to find out whether mitral regurgitation (or a leaky heart valve) caused by ischemic heart disease (decreased blood flow to heart muscle) will improve after administration of ranolazine.
- Trial name
- REIN-MR (NCT01979965)
- Testing
- Ranolazine (Active drug)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University Cardiology
Heart Failure
Targeted Left Ventricular Lead Placement, Comparison of Active Fixation Bipolar and Passive Quadripolar Pacemaker Leads
A prospective, randomized and patient-blinded trial comparing an active fixation left ventricular lead with quadripolar passive left ventricular leads.
- Trial name
- NCT04632472
- Testing
- Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy
- Where
- Norway
- Volunteers
- 62 people
- Sponsor
- Haukeland University Hospital
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
Heart Failure, Atrial Fibrillation
Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation
Atrial fibrillation and heart failure are two common heart conditions that are associated with an increase in death and suffering. When both of these two conditions occur in a patient the patient's prognosis is poor.
- Trial name
- RAFT-AF (NCT01420393)
- Testing
- Rhythm control, Rate Control
- Where
- 21 sites in Brazil, Canada and 2 more
- Volunteers
- 411 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Hypertrophic Cardiomyopathy
A Comparison of Two Treatments: Pacemaker and Percutaneous Transluminal Septal Ablation for Hypertrophic Cardiomyopathy
This study will compare two treatments: pacemaker implantation and percutaneous transluminal septal ablation (PTSA) for patients with hypertrophic cardiomyopathy (HCM), a condition in which the heart muscle thickens and obstructs…
- Trial name
- NCT00001894
- Testing
- pacemaker implantation, percutaneous transluminal septal ablation (PTSA)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Atrial Tachycardia
PVC Response ''Atrial Pace'' Inducing Atrial Tachycardias
Premature ventricular contractions (PVC) are common phenomenon and occasionally retrograde conduction from ventricle to atrium occurs and may cause pacemaker mediated tachycardia.
- Trial name
- NCT05344456
- Testing
- Change in the device PVC algorithm to ''Off''
- Where
- Finland
- Volunteers
- 16 people
- Sponsor
- Helsinki University Central Hospital
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
Hypertrophic Cardiomyopathy
Studying the Effectiveness of Pacemaker Therapy in Children Who Have Thickened Heart Muscle
A heart condition called hypertrophic cardiomyopathy (HCM) causes abnormal thickening of the heart muscle, which obstructs the flow of blood out of the heart.
- Trial name
- NCT00001960
- Testing
- Pacemaker therapy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and…
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree, Heart Failure
- Trial name
- CIED-CARE (NCT06652750)
- Testing
- Routine Management, 5G Cloud Follow-up
- Where
- 2 sites in China
- Volunteers
- 688 people
- Sponsor
- The Third People's Hospital of Chengdu
Arrhythmia, Sinus Node Disease
PANORAMA Observational Study
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy)…
- Conditions
- Arrhythmia, Sinus Node Disease, Heart Failure, Heart Block
- Trial name
- NCT00382525
- Testing
- Cardiac Rhythm Management device
- Where
- 27 sites in Belgium, India and 4 more
- Volunteers
- 8,586 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Congestive Heart Failure
PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Conditions
- Heart Failure, Congestive Heart Failure, Cardiomyopathy
- Trial name
- NCT00253357
- Where
- 28 sites in United States, Austria and 11 more
- Volunteers
- 450 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
ICD, Pacemaker DDD
Postcards to Improve Remote Monitoring Adherence Among Veterans
We tested the effect of informational postcards on improving remote monitoring adherence among Veterans with pacemakers and implantable cardioverter-defibrillators in a stepped-wedge randomized controlled trial.
- Conditions
- ICD, Pacemaker DDD, Adherence, Patient
- Trial name
- NCT06068699
- Testing
- Postcard
- Where
- United States
- Volunteers
- 6,351 people
- Sponsor
- US Department of Veterans Affairs
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
Heart Block, Aortic Stenosis
Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).
The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in…
- Conditions
- Heart Block, Aortic Stenosis, Bundle-Branch Block
- Trial name
- GLUCO-TAVR (NCT06076824)
- Testing
- Methylprednisolone
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital General Universitario de Alicante
Pacemaker DDD, His Bundle Pacing
Pacing to Maintain Physiologic Ventricular Activation
Right ventricular pacing causes ventricular dyssynchrony and may be associated with impaired outcome. In the last decade, several approaches for more physiological pacing became available and were implemented in the latest…
- Conditions
- Pacemaker DDD, His Bundle Pacing, LBB Area Pacing, Pacing-Induced Cardiomyopathy
- Trial name
- Pace-Conduct (NCT04416958)
- Testing
- cardiac implantable electronic device (CIED) implantation
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Klinikum-Fuerth
Atrial Arrhythmia, Atrial Tachycardia
ATrial Tachycardia PAcing Therapy in Congenital Heart
Congenital heart disease (CHD) affects approximately 1% of newborns in the US, with 25% of those affected having critical conditions requiring open heart surgery within one year of birth.
- Conditions
- Atrial Arrhythmia, Atrial Tachycardia, Congenital Heart Disease, Pacemaker Re-Entrant Tachycardia
- Trial name
- AT-PATCH (NCT03209583)
- Testing
- Medtronic
- Where
- 15 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- Ian Law
Chronic Heart Failure
Tailoring Pacemaker Output to Physiology in Chronic Heart Failure
Aims: To explore the clinical effect on exercise tolerance and quality of life, safety and tolerability of pacing at higher outputs in patients with chronic heart failure and a pacemaker.
- Trial name
- NCT03781427
- Testing
- Cardiac resynchronization therapy
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- University of Leeds
Pacemaker Ddd, ICD
Evaluation of CIED "Readers" for Disease Management
The purpose of this study is to evaluate the use of remote interrogation (readers) of CIEDs in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope.
- Trial name
- NCT03338946
- Testing
- CIED interrogation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Edward Hospital
Sinus Node Dysfunction, Sick Sinus Syndrome
Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction
Endocardial ganglion plexus ablation (cardioneuroablation) represents a promising therapeutic technique for the treatment of vasovagal syncope (VV), functional atrioventricular block (AVB) and sinus node dysfunction (SND) with a…
- Trial name
- DINERVAPACE (NCT05186220)
- Testing
- Cardioneuroablation, Permanent dual chamber pacemaker implantation
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Hospital Clinico Universitario de Santiago
Heart Failure, Pacemaker DDD
Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
Left bundle branch block (LBBB) exists in about 25% of patients with congestive heart failure and is associated with worsened prognosis.
- Conditions
- Heart Failure, Pacemaker DDD, Cardiomyopathies, Heart Diseases
- Trial name
- NIME-CRT (NCT05868616)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- Norway
- Volunteers
- 80 people
- Sponsor
- Oslo University Hospital