Clinical trials: Pacemaker Malfunction
Device Malfunction, ICD
Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction
The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular…
- Conditions
- Device Malfunction, ICD, Pacemaker Lead Dysfunction
- Trial name
- ISEE (NCT04055740)
- Testing
- IVUS Imaging
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Chicago
Heart Failure, Congestive
RESynchronisation in Patients With Heart Failure and a Normal QRS Duration
Patients who have heart failure and have electrical evidence of delay in the contraction of the left ventricle on an ECG tracing of the heart are eligible for biventricular pacing.
- Trial name
- RESPOND (NCT00480051)
- Testing
- Cardiac Resynchronization Pacing
- Where
- 2 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- Heart of England NHS Trust
Atrial Fibrillation, Congestive Heart Failure
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing…
- Trial name
- AVAIL (NCT00356057)
- Testing
- Protos DR/CLS and Stratos LV CRT pacemakers
- Where
- 10 sites in United States
- Volunteers
- 153 people
- Sponsor
- Biotronik, Inc.
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
Myocardial Infarction (MI), Pacemaker Implantation
Augmented Reality as Discharge Information for Hospitalized Cardiology Patients
The goal of this clinical trial is to find out whether a simple augmented reality tool provided at hospital discharge can improve patients' understanding of their care, adherence to treatment, and health outcomes, compared with…
- Conditions
- Myocardial Infarction (MI), Pacemaker Implantation, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- RACAR (NCT07399379)
- Testing
- Augmented reality app
- Where
- Spain
- Volunteers
- 303 people
- Sponsor
- Hospital Universitario Getafe
Atrial Fibrillation, Heart Failure
AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with…
- Trial name
- PACIFIC (NCT00589303)
- Testing
- FDA approved rate and rhythm control drugs, AV Node ablation and device implant
- Where
- 6 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Mayo Clinic
Heart Failure, Dilated Cardiomyopathy
PITA-HF: Feasibility, Safety, and Tolerability
Heart failure affects over 25 million people worldwide and nearly 7 million adults in the United States alone. Nearly 25% of patients with heart failure have worsened disease burden from dyssynchronous ventricular contraction due…
- Trial name
- NCT04159454
- Testing
- PITA
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Johns Hopkins University
Cardiomyopathy, Cardiac Arrhythmia
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
If a surgical sponge is mistakenly left inside a patient's body after a surgical procedure, it can cause a serious infection. To prevent this from happening, a new device has been developed that uses radiofrequency (RF) signals…
- Conditions
- Cardiomyopathy, Cardiac Arrhythmia, Heart Failure, Chronic Thromboembolic Pulmonary Hypertension
- Trial name
- RF (NCT02111980)
- Testing
- RF Assure Scanning
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
Heart Failure, Cardiac Resynchronisation Pacemakers
Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
An evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers.
- Trial name
- CHOICE2 (NCT01055210)
- Testing
- Optimisation of VV delay
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- University of Dundee
Bradycardia, Heart Failure
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt…
- Trial name
- NCT06018818
- Testing
- Amvia/Solvia pacemaker family
- Where
- 3 sites in Austria, Germany
- Volunteers
- 129 people
- Sponsor
- Biotronik SE & Co. KG
Heart Disease, Cardiovascular Disease
Remote Device Interrogation In The Emergency Department
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REMEDY (NCT01871090)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
Pacemaker
Effects of Inspiratory Muscle and Endurance Training in Heart Failure Patients With Pacemaker
It is well-known that not only peripheral muscles, but also respiratory muscles muscle weakness and deconditioning play an important role in low exercise capacity of patients with Heart Failure (HF).
- Trial name
- NCT03501355
- Testing
- Inspiratory muscle strength training, Inspiratory muscle endurance training
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- Gazi University
Left Ventricular Dysfunction, Heart Failure, Systolic
Reprogramming to Prevent Progressive Pacemaker-induced Remodelling
The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.
- Conditions
- Left Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure, Pacemaker; Complication, Mechanical
- Trial name
- PPPR (NCT03627585)
- Testing
- Personalised programming
- Where
- 2 sites in United Kingdom
- Volunteers
- 91 people
- Sponsor
- University of Leeds
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
Periodic Breathing
Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.
To evaluate whether cardiac output manipulation via a cardiac pacemaker can stabilise ventilation.
- Trial name
- NCT01044407
- Testing
- Pacemaker manipulation
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Imperial College London
Heart Failure, Systolic, Left Bundle Branch Block
Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure
Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is indicated for patients with low ejection fraction and persistent symptoms of heart failure despite medical therapy and a wide QRS-complex, preferably with…
- Conditions
- Heart Failure, Systolic, Left Bundle Branch Block, Wide QRS Complex
- Trial name
- HEPA-His (NCT04701112)
- Testing
- Temporary His bundle pacing
- Where
- Sweden
- Volunteers
- 2 people
- Sponsor
- Region Skane
Bundle-Branch Block, Left, Cardiac Failure
Prognosis of Patients With Compete Left Bundle Branch Block
The investigators sought to evaluate the morphological and functional changes, risk stratification and prognosis of patients of participants with compete left bundle branch block (CLBBB).
- Conditions
- Bundle-Branch Block, Left, Cardiac Failure, ICD/Pacemaker Implantation, Cardiovascular Magnetic Resonance Imaging
- Trial name
- NCT03096678
- Testing
- Cardiac Magnetic Resonance Imaging
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Heart Failure, Systolic
Optimising Pacemaker Therapy Using Multi-point Pacing (the OPT-MPP Study)
Recently, the introduction of quadripolar left ventricular leads (one with four pacing poles) has allowed the opportunity to pace the lateral (back) of the heart from several points at once using a single lead (multi-point pacing…
- Trial name
- OPT-MPP (NCT03220659)
- Testing
- Multi-point pacing, Standard settings
- Where
- United Kingdom
- Volunteers
- 23 people
- Sponsor
- University of Leeds
Heart Failure, Bradycardia
Impact of Optimized Pacing Strategies on Clinical and Hemodynamic Outcomes in Heart Failure Patients With Pacemaker
This study aims to evaluate the clinical impact of an optimized pacing strategy in patients with heart failure. Intervention: Adjustment of the pacemaker lower rate limit to an individualized, hemodynamically optimized heart…
- Trial name
- OPTPACE-HF (NCT07563153)
- Testing
- Adjustment of the pacemaker/ICDs lower rate limit (LRL), Conventional lower rate (60bpm)
- Where
- South Korea
- Volunteers
- 106 people
- Sponsor
- Samsung Medical Center
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