Clinical trials: Cardiac Pacemaker Malfunction
Congenital Disorder
Pacemaker Therapy in Adults With Congenital Heart Defects
Review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications
- Trial name
- NCT00303511
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Emory University
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 Failure With Preserved Ejection Fraction, Atrial Dyssynchrony Syndrome
LEft Atrial Pacing in Diastolic Heart Failure
The purpose of this study is to assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction.
- Conditions
- Heart Failure With Preserved Ejection Fraction, Atrial Dyssynchrony Syndrome, Left Atrio-ventricular Asynchrony
- Trial name
- LEAD (NCT01618981)
- Testing
- pace make active/inactive cross over
- Where
- France
- Sponsor
- Centre Hospitalier Universitaire Dijon
Bradyarrhythmia, Pacemaker Syndrome
Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study
Study of the ventricular activation patterns during left bundle area pacing and compare it with baseline activation during normal sinus rhythm in patients with and without baseline bundle branch conduction disorder.
- Conditions
- Bradyarrhythmia, Pacemaker Syndrome, Biventricular Cardiac Pacemaker Malfunction
- Trial name
- LBBAP (NCT05401851)
- Testing
- Left Bundel Area Pacing
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- Universitair Ziekenhuis Brussel
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
Pacemaker Complication, Congestive Heart Failure
Optimised Pacing Program
Permanent pacemakers are a common treatment for slow heart beats. In the UK 300,000 people have a pacemaker, and each year another 36,000 receive them. All of these patients are usually seen yearly to have their device checked.
- Trial name
- OPT-pace (NCT01819662)
- Testing
- Enhanced standard management, Optimised heart failure management, Standard management
- Where
- 3 sites in United Kingdom
- Volunteers
- 1,793 people, healthy volunteers welcome
- Sponsor
- University of Leeds
Pacemaker Malfunction
Human Use Condition Study- Evaluation of Implanted Leads in Humans
The purpose of this study is to evaluate different types of leads (wires) that are connected to your pacemaker (an implanted device which assists your heart function) to understand how the shape and motion of your previously…
- Trial name
- HUCS (NCT04320849)
- Where
- 5 sites in United States
- Volunteers
- 117 people
- Sponsor
- Duke University
Any Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA Guidelines
Comparison of AAIsafeR and DDD Modes in Non-selected Patients
1 Purpose In patients with sinus node dysfunction (SND), the use of AAI mode is rare. In paroxysmal high-degree or complete atrio-ventricular (AV) block, paroxysmal vagally-mediated bradycardia, single chamber atrial pacemakers…
- Trial name
- CAN-SAVE R (NCT01219621)
- Testing
- Symphony Dual Chamber Rate Responsive Device
- Where
- 10 sites in Canada
- Volunteers
- 450 people
- Sponsor
- Sorin Group Canada
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
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
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
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
- 338 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
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
Cardiac Resynchronisation Therapy (CRT), Heart Failure
A Study Testing a New Heart Scan Method to Improve Pacemaker Treatment for Heart Failure
Cardiac resynchronization therapy (CRT) is a device treatment for patients with heart failure which cannot be managed by medications alone. CRT can help the heart contract more efficiently and improve the pumping function.
- Trial name
- EFFECT-CRT (NCT07084467)
- Testing
- EF1 guided CRT optimisation, Standard of Care (SOC)
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- King's College London
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
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
Heart Failure With Reduced Ejection Fraction
The Effect of Combined Upper and Lower Extremity Endurance Training in Patients With ICD
It was aimed to examine whether the arm endurance exercise training is effective in addition to the lower cycling training program in order to alleviate the negative functional results in heart failure patients with ICD.
- Trial name
- ICD (NCT04803968)
- Testing
- bicycle ergometer and arm ergometer exercise, bicycle ergometer exercise
- Where
- Turkey (Türkiye)
- Volunteers
- 45 people
- Sponsor
- Hitit University
Heart Failure
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.
- Trial name
- DANLOGIC-HF (NCT06099158)
- Testing
- HeartLogic
- Where
- 5 sites in Denmark
- Volunteers
- 1,428 people
- Sponsor
- Tor Biering-Sørensen
Cardiac Pacemaker Malfunction, ICD Malfunction
Perioperative Management Evaluation in Patients With CIED
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
- Conditions
- Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication
- Trial name
- EVINCE (NCT04331249)
- Testing
- surgery or catheter based cardiac procedure (catheter ablation)
- Where
- 2 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Klinikum-Fuerth
Heart Failure, Congestive
X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure
The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation (more than 80%); are eligible for the exchange of an old pacemaker or implantable…
- Trial name
- NCT00157846
- Testing
- CRT-P or CRT-D Device
- Where
- 10 sites in Germany
- Volunteers
- 36 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure