Clinical trials: Pacemakers
Stenoses, Aortic Valve, Aortic Insufficiency
Perceval Aortic Bioprostheses : Durability Study.
Aortic valve replacement is one of the most commonly performed procedures in adult cardiac surgery in France. Patients over the age of 65 most often receive a bioprosthetic aortic valve during an isolated aortic valve replacement…
- Conditions
- Stenoses, Aortic Valve, Aortic Insufficiency, Aortic Diseases
- Trial name
- NCT07116265
- Volunteers
- 192 people
- Sponsor
- University Hospital, Montpellier
Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
Registry Study of Clinical Application of MRI Compatible CIED
The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).
- Trial name
- NCT02380300
- Volunteers
- 2,067 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Atrial Fibrillation
Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden
The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent…
- Trial name
- NCT01356914
- Testing
- BMS-914392
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Bristol-Myers Squibb
TAVI
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
Pacemaker requirement in the immediate post procedure phase following TAVI is approximately 20% depending on device type and patient characteristics.
- Trial name
- NCT02700633
- Testing
- Pacemaker
- Volunteers
- 4,000 people
- Sponsor
- Royal Sussex County Hospital
Congenital Heart Disease
Subcostal Transverse Abdominis Plane Block for Epigastric Cardiac Pacemaker Operation
This prospective randomized controlled trial aims to examine the effect of subcostal transverse abdominis plane block on the postoperative pain and opioid consumption in patients (12y≤ age) who will undergo epigastric cardiac…
- Trial name
- NCT04570878
- Testing
- SC TAP, Control
- Where
- South Korea
- Volunteers
- 22 people
- Sponsor
- Seoul National University Hospital
Atrial Fibrillation
Predicting Development of SCAF in Device Patients
Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that are only detected by implanted pacemakers or defibrillators. Usually people don't know that they have these episodes.
- Trial name
- NCT02808260
- Where
- Canada
- Volunteers
- 500 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Atrial Fibrillation, Tachycardia, Supraventricular
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of…
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia
- Trial name
- NCT00289289
- Testing
- Intervention Pacing Features
- Where
- 38 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Pacemaker, Heartfailure
The Effect of CRT on the Frank Starling Mechanism
The investigators are examining a scientific principle called the Frank Starling Mechanism and how it relates to Cardiac Resynchronisation Therapy (CRT), a form of pacemaker therapy used in the treatment of heart failure.
- Trial name
- CRT (NCT05993585)
- Testing
- Test Of The Frank Starling Mechanism - Adjustment Of Av Delay And Measurement Of Pre-load -Control, Other: Test Of The Frank Starling Mechanism - Adjustment Of Av Delay And Measurement Of Pre-load -CRT
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Atrial Fibrillation, Arrythmia
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF).
- Trial name
- ABC (NCT05704426)
- Testing
- Impulse Dynamics Optimizer Device
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Hackensack Meridian Health
Bradycardia, Heart Failure
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy
LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant…
- Conditions
- Bradycardia, Heart Failure, Pacemaker-Induced Cardiomyopathy, Conduction Block, Atrioventricular
- Trial name
- LEAP-CAR (NCT05910866)
- Testing
- Left bundle branch area pacing (LBBAP), Right ventricular pacing (RVP)
- Where
- Italy
- Volunteers
- 130 people
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
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
Paroxysmal Atrial Fibrillation
Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP
The purpose of this study is 3 fold:- 1. To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation…
- Trial name
- LAAPITUP (NCT01095770)
- Testing
- AF Ablation with Ablation Frontiers Technology, AF Ablation with LASSO catheter, Reveal XT
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- East Sussex Healthcare NHS Trust
Cardiac Pacemaker, Arrythmia
AVEIR DR Coverage With Evidence Development (CED) Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05932602
- Testing
- Aveir DR Leadless Pacemaker System, Dual Chamber Transvenous Pacemaker
- Where
- United States
- Volunteers
- 2,812 people
- Sponsor
- Abbott Medical Devices
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
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
Infection
MAKE IT CLEAN, Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study
To determine the effect of scar tissue removal on the rate of infection and any other complications such as bleeding in patients with an ICD or pacemaker who have the device generator or leads replaced or repositioned.
- Trial name
- NCT00599261
- Testing
- ICD/pacemaker pocket revision
- Where
- United States
- Volunteers
- 265 people
- Sponsor
- Dhanunjaya Lakkireddy, MD, FACC
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
Pacemaker, TAVI
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI).
- Conditions
- Pacemaker, TAVI, Risk Score
- Trial name
- TAVI PACER (NCT06542380)
- Testing
- TAVI, pacemaker
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- German Heart Institute
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
Sinus Bradycardia
Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
This is a multicenter randomized controlled study. By comparing patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation and pacemaker therapy, and long-term follow-up to evaluate its safety and…
- Trial name
- NCT05021627
- Testing
- Cardiac autonomic nerve modification, Pacemaker implantation
- Volunteers
- 240 people
- Sponsor
- Shanghai Chest Hospital