Clinical trials: Pacemaker Therapy
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, 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
ICD, Pacemaker
Postcards to Improve Remote Monitoring Connectivity Among Veterans With a Disconnected Monitor
We tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices who have lost continuous RM connectivity because of a disconnected home monitor.
- Conditions
- ICD, Pacemaker, Implanted Loop Recorder, Remote Monitoring
- Trial name
- NCT07464834
- Testing
- Tailored Postcard
- Where
- United States
- Volunteers
- 2,726 people
- Sponsor
- San Francisco VA Health Care System
Pacemaker Implantation, Pocket Hematoma and Bleeding
Pocket Haematoma Prevention in Patients Who Required Implantation/Replacement of a Pacemaker or Implantable Cardiac Defibrillator. The PHP Study.
The aim of this study is to demonstrate the efficacy of fibrin sealant (Tissucol-Baxter) in preventing pocket haematoma and subsequent complications in patients undergoing pacemaker or ICD implantation/replacement which cannot…
- Conditions
- Pacemaker Implantation, Pocket Hematoma and Bleeding, Antiplatelet Therapy or Oral Anticoagulants
- Trial name
- PHP (NCT01127984)
- Testing
- tissucol, drainage system
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Careggi Hospital
Hypertension
Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients
The purpose of this study is to test whether the A-V sequential pacing strategy shown to effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure acutely in patients with hypertension (systolic…
- Trial name
- NCT02382484
- Testing
- A dual chamber pacing system (BackBeat Medical)
- Where
- China
- Volunteers
- 19 people
- Sponsor
- BackBeat Medical Inc
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
Ventricular Tachyarrhythmias, ICD Shock Therapy
Sub-threshold Pacing to Prevent Pacemaker-induced Ventricular Tachycardia
Implantable cardioverter defibrillators (ICD) may have the capacity to provoke or worsen ventricular tachyarrhythmias (VT). It has been reported that ICD shocks by itself can increase mortality.
- Conditions
- Ventricular Tachyarrhythmias, ICD Shock Therapy, ICD Shock Burden
- Trial name
- NCT01906775
- Testing
- Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level
- Where
- Germany
- Volunteers
- 550 people
- Sponsor
- Johannes Gutenberg University Mainz
Post-operative Pain
A Trial Assessing The Association Between Type Of Local Anesthesia Treatment And Postoperative Pain In Patients In Having Undergone Arrhythmia Surgery
The goal of the proposed study is to investigate the relationship between two standard treatments, lidocaine or a mixture of lidocaine and bupivacaine, and 1) postoperative pain, and; 2) narcotic use following pacemaker or…
- Trial name
- NCT01300377
- Testing
- Bupivacaine / Lidocaine, Lidocaine
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Baylor Research Institute
Heart Failure and Reduced Ejection Fraction, Dyssynchrony
Comparing Three Types of Specialist Pacemakers to Improve Heart Function and Reduce Rhythm Problems in Heart Failure
The goal of this clinical trial is to find out which type of specialist pacemaker-known as cardiac resynchronisation therapy (CRT)-works best for people with heart failure and a delay in how the lower chambers of the heart beat…
- Trial name
- RIPCORD-CRT (NCT07430553)
- Testing
- Biventricular pacing, Conduction system pacing, Left bundle optimised cardiac resynchronisation therapy
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Imperial College London
Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.
Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
- Trial name
- ANSWER (NCT00562107)
- Testing
- Symphony DR 2550 and REPLY DR cardiac pacemakers
- Where
- 37 sites in United States, France and 4 more
- Volunteers
- 650 people
- Sponsor
- LivaNova
Pacing-Induced Cardiomyopathy, Heart Failure
Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing…
- Trial name
- PROTECT-UP (NCT06052475)
- Testing
- Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing), Continued RV Pacing (Right Ventricular Pacing)
- Where
- 12 sites in United Kingdom
- Volunteers
- 155 people
- Sponsor
- Imperial College London
Sick Sinus Syndrome
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.
- Trial name
- NCT00161538
- Testing
- Pacing leads to be implanted according randomization., Selection 9000 prevent AF an Diagnose AF
- Where
- 12 sites in Germany
- Volunteers
- 456 people
- Sponsor
- Medtronic BRC
Bradycardia, Brady-tachy Syndrome
ALPs Single ChambEr New Device
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Bradycardia, Brady-tachy Syndrome, AV Block, Atrial Fibrillation (AF)
- Trial name
- ASCEND (NCT07461935)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 10 people
- Sponsor
- Cairdac SA
Heart Failure, Systolic
R-wave Optimisation in Cardiac Resynchronisation Therapy Study
The aim of this study is to investigate whether the use of a simple feature on the 12 lead electrocardiogram (ECG) to optimise pacemaker device programming can have clinically relevant benefit to patient management.
- Trial name
- NCT02080000
- Testing
- Optimisation of V-V timing using R wave on surface ECG, Standard V-V timing settings
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- The Royal Bournemouth Hospital
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
Atrial Fibrillation, Bradycardia
Study for Atrial Fibrillation Reduction (SAFARI)
Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat.
- Trial name
- NCT00267137
- Testing
- Pacing Algorithms
- Where
- 34 sites in United States
- Volunteers
- 540 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
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
Cardiomyopathy
Sleep Apnea and CRT Upgrading
Cardiac resynchronization therapy may reduce central sleep apnea, but there is no prospective randomized study so far demonstrating such an effect in patients with conventional pacemaker undergoing upgrading to CRT because of…
- Trial name
- NCT01970423
- Testing
- CRT, conventional right ventricular stimulation
- Where
- 2 sites in Austria
- Volunteers
- 56 people
- Sponsor
- Medical University Innsbruck
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