Clinical trials: Cardiac Pacemaker Malfunction
Heart Failure
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4
- Trial name
- NCT02191696
- Testing
- IMED-4 recording
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Intersection Medical, Inc.
Permanent Atrial Fibrillation, Preserved Ejection Fraction
Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial
The goal of this clinical trial is to learn whether left bundle branch area pacing, a technique designed to activate the heart's natural electrical conduction system, is better than conventional right ventricular pacing in adults…
- Trial name
- BEAT (NCT07759700)
- Testing
- LBBA pacing, Conventional pacing
- Where
- France
- Volunteers
- 642 people
- Sponsor
- Poitiers University Hospital
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
Heart Failure With Preserved Ejection Fraction
SHort Of Pace - Heart Failure (SHOP-HF)
This study is designed as a multicenter, prospective, controlled, randomized, two-arms, cross-over, two parallel cohorts, efficacy Clinical research with CE-marked medical device .
- Trial name
- NCT06992089
- Testing
- Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
Chronic Heart Failure
Optimising Pacemaker Therapy for Contractility
The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF).
- Trial name
- OPT-C (NCT02964650)
- Testing
- Personalised rate-response settings
- Where
- United Kingdom
- Volunteers
- 83 people
- Sponsor
- University of Leeds
Heart Failure
One Day Implantation Program for Heart Failure Patients Implanted With CRT-P
This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis
- Trial name
- OEDIPE-CRT-P (NCT05142293)
- Testing
- Ambulatory procedure
- Where
- 19 sites in France
- Volunteers
- 354 people
- Sponsor
- Biotronik SE & Co. KG
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
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
Defibrillators, Implantable, Heart Failure With Reduced Ejection Fraction
Multi-centre Observational Registry on Patients With Implantable Devices Remotely Monitored
Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring.
- Conditions
- Defibrillators, Implantable, Heart Failure With Reduced Ejection Fraction, Arrythmia, Pacemaker
- Trial name
- IMPLANTED (NCT03061747)
- Testing
- Assesment of outcome of implantable device patients
- Where
- 6 sites in Italy
- Volunteers
- 1,000 people
- Sponsor
- Azienda Ospedaliera Cardinale G. Panico
Heart Failure
LV Dysfunction Following Pacemaker Placement
Several studies have confirmed the link between chronic RV apical pacing and the development of heart failure and LV systolic dysfunction in some patients 1,2.
- Trial name
- NCT03850808
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Oregon Health and Science University
Heart Failure, Systolic, Pacemaker
Optimising Pacing for Contractility 2
The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF).
- Trial name
- OPT-cont 2 (NCT04201015)
- Testing
- Heart rate optimisation using force frequency data
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- University of Leeds
Heart Failure
Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure
In this study we will select twenty patients with chronic atrial fibrillation and ventricular dysfunction with permanent cardiac pacemaker indication.
- Trial name
- NCT02186314
- Testing
- Pacemaker Biotronik: apical stimulation, Pacemaker Biotronik: bifocal stimulation
- Where
- Brazil
- Volunteers
- 20 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Atrial Fibrillation, Bradycardia
Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class
This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be…
- Conditions
- Atrial Fibrillation, Bradycardia, Heart Block, Sick Sinus Syndrome
- Trial name
- NCT00292539
- Testing
- Any pacemaker with right ventricular pacing option
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- Guidant Corporation
Congestive Heart Failure, Atrial Fibrillation
Study to Characterize Atrial Fibrillation in CHF Patients Indicated for CRT
The purpose of the study is to characterize atrial arrhythmias in patients indicated for Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while CRT is provided.
- Trial name
- NCT00156728
- Testing
- Vitatron biventricular pacemaker
- Where
- 23 sites in Czechia, France and 5 more
- Volunteers
- 172 people
- Sponsor
- Medtronic BRC
Aortic Valve Stenosis, Heart Failure
Conventional Versus Left Bundle Branch Pacing in TAVI
This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left…
- Conditions
- Aortic Valve Stenosis, Heart Failure, Pacemaker-Induced Cardiomyopathy, Transcatheter Aortic Valve Implantation
- Trial name
- NCT05895097
- Testing
- Left bundle branch pacemaker, Conventional pacing
- Where
- Slovenia
- Volunteers
- 50 people
- Sponsor
- University Medical Centre Ljubljana
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.
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
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
Atrial Fibrillation, Heart Failure
RAFT - Pace &Ablate
Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs.
- Conditions
- Atrial Fibrillation, Heart Failure, Pacemaker, Arrhythmia Atrial
- Trial name
- RAFT-P&A RCT (NCT06299514)
- Testing
- Pace and Ablate, Medication
- Where
- 12 sites in Canada
- Volunteers
- 600 people
- Sponsor
- Habib Khan
Cardiac Arrhythmia, Heart Failure
Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants
The study will include patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation.
- Conditions
- Cardiac Arrhythmia, Heart Failure, AV Block
- Trial name
- TUFF (NCT04867460)
- Testing
- Ultrasound guided venous access
- Where
- Sweden
- Volunteers
- 58 people
- Sponsor
- Region Skane