Clinical trials: Cardiac Pacemaker Malfunction
Heart Failure With Reduced Ejection Fraction
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation.
- Trial name
- RSA-PACE (NCT06384963)
- Testing
- Atrial pacing with respiratory sinus arrhythmia (RSA) variability, Monotonic right atrial overdrive pacing
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 54 people
- Sponsor
- Ceryx Medical Australia
Heart Failure
Trial in Cardiac Resynchronization Therapy (CRT): Right Ventricular Apex Versus High Posterior Septum
In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker.
- Trial name
- NCT01035489
- Testing
- CRT in heart failure; Right ventricular apex v.s. high posterior septum
- Where
- Norway
- Volunteers
- 85 people
- Sponsor
- Haukeland University Hospital
Heart Failure, Congestive
HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
The literature shows that approximately 40% of individuals who receive a cardiac resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not have a clinical benefit from the device.
- Trial name
- NCT00370526
- Testing
- Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 100 people
- Sponsor
- Stereotaxis
Heart Failure
CareLink® Network Evaluation
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
- Trial name
- NCT01023022
- Testing
- Medtronic CareLink® Network
- Where
- 10 sites in Poland
- Volunteers
- 176 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Exercise Tolerance
Effects of Atrial Rate-adaptive Pacing on Exercise Capacity in Patients With Chronic Heart Failure Complicated by Chronotropic Incompetence
Chronotropic incompetence consists of an insufficient increase in heart rate during effort, and its presence is recognized as a common feature in patients with heart failure due to left ventricular systolic dysfunction…
- Trial name
- NCT01016431
- Testing
- Rate-adaptive pacemaker programming, VVI at 40 bpm
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Federico II University
Transcatheter Aortic Valve Replacement
Prognostic Factors in NOP-LBBB After TAVI
The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI).
- Trial name
- ProgNOP-LBBB (NCT05654792)
- Testing
- Transcatheter aortic valve implantation
- Volunteers
- 230 people
- Sponsor
- Central Hospital, Nancy, France
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
Congestive Heart Failure
Electrophysiological Optimization of Left Ventricular Lead Placement in CRT
The purpose of this study is to investigate if "optimal electrical resynchronization" achieved by targeting left ventricular lead placement to the myocardial region with the latest electrical activation combined with post-implant…
- Trial name
- ElectroCRT (NCT02346097)
- Testing
- Cardiac Resynchronization Therapy (St. Jude Qaudripolar LV lead)
- Where
- Denmark
- Volunteers
- 122 people
- Sponsor
- University of Aarhus
Left Bundle Branch Pacing, Heart Failure
Left Bundle Branch Area Pacing 3D Guidance System
The investigator's project proposes the development of a 3D hybrid guidance system which has the aim of avoidance of scar and septal perforation through targeted lead deployment via a personalised septal real time image overlay…
- Conditions
- Left Bundle Branch Pacing, Heart Failure, Bradycardia
- Trial name
- NCT06461715
- Testing
- Machine learning with artificial intelligence software program
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Sinus Node Disease
Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence…
- Trial name
- B3 (NCT02579889)
- Testing
- DDD+CLS, DDD(R)
- Where
- 54 sites in China, Hungary and 7 more
- Volunteers
- 1,390 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
- Trial name
- TLC-AU (NCT06561932)
- Testing
- WiSE CRT System
- Where
- 4 sites in Australia
- Volunteers
- 40 people
- Sponsor
- EBR Systems, Inc.
Dysrhythmia, Cardiac, Heart Failure
Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans
Particularly in CRT (Cardiac Resynchronisation Therapy), limited accessibility of the coronary sinus along with its branches and the mismatch between the region of latest left ventricular (LV) contraction and an adequate…
- Conditions
- Dysrhythmia, Cardiac, Heart Failure, Pacemaker Electrode Infection, Hemodialysis-Induced Symptom
- Trial name
- VAPS (NCT03387488)
- Testing
- StingrayTM, Medtronic®
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- RWTH Aachen University
Heart Failure
REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor
However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is…
- Trial name
- REMOTE-HEART (NCT06173089)
- Testing
- Remote monitoring
- Where
- Hungary
- Volunteers
- 800 people
- Sponsor
- Semmelweis University Heart and Vascular Center
Atrial Fibrillation (AF), Pacemaker Therapy
Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF
This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate…
- Conditions
- Atrial Fibrillation (AF), Pacemaker Therapy, Atrioventricular Block, Preserved Ejection Fraction
- Trial name
- LBBP-AHRE (NCT07250529)
- Testing
- Right Ventricular Pacing, Left Bundle Branch Pacing
- Where
- Greece
- Volunteers
- 244 people
- Sponsor
- University Hospital of Patras
Atrioventricular Block, Second and Third Degree, Pacemaker-Induced Cardiomyopathy
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular…
- Conditions
- Atrioventricular Block, Second and Third Degree, Pacemaker-Induced Cardiomyopathy, Heart Failure
- Trial name
- STAY (NCT06026683)
- Testing
- Pacemaker implant
- Where
- Spain
- Volunteers
- 75 people
- Sponsor
- Parc de Salut Mar
Heart Failure, Hypertension
Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals
This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.
- Trial name
- NCT02337790
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Baxter Healthcare Corporation
Atrial Fibrillation, Stroke
TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
The purpose of this study is to look at the heart rate and rhythm information collected daily in Medtronic implantable pulse generators (IPG), implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy…
- Conditions
- Atrial Fibrillation, Stroke, Heart Failure
- Trial name
- NCT00279981
- Testing
- Diagnostic
- Where
- 98 sites in United States, Australia and 1 more
- Volunteers
- 3,100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Cardiac Resynchronization in the Elderly
This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare…
- Trial name
- NCT03031847
- Testing
- Cardiac Resynchronization Therapy Pacemaker, Cardiac Resynchronization Therapy Defibrillator
- Where
- 6 sites in United States
- Volunteers
- 102 people
- Sponsor
- Samir Saba
Congestive Heart Failure
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
- Trial name
- NCT00158938
- Testing
- EASYTRAK 3 left ventricular pacing lead
- Volunteers
- 115 people
- Sponsor
- Boston Scientific Corporation
Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block
Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity.
- Conditions
- Congenital Complete Atrioventricular Heart Block, High Grade Atrioventricular Block, Postoperative Complete Heart Block
- Trial name
- NCT01477658
- Where
- Brazil
- Volunteers
- 140 people
- Sponsor
- University of Sao Paulo