Clinical trials: Cardiac Resynchronization Therapy Devices
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
The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision
St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.
- Trial name
- REACT (NCT01090349)
- Testing
- Implantation of an ICD/CRT-D device, Merlin.NET PCN
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 220 people
- Sponsor
- Abbott Medical Devices
Cardiac Resynchronization Therapy
SonR Based Stimulation-VECtor OPTimisation in CRT Patients
The primary aim of the present study is to investigate whether the optimisation of LVSV in addition to the optimisation of AV-D and VV-D when using the device-based sensor technology mentioned above results in an improved…
- Trial name
- VECTOPT (NCT03092349)
- Testing
- Vector optimisation
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Heart Failure, Implantable Cardioverter Defibrillator (ICD)
Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices
The aim of this study is to evaluate in detail the factors that determine upper extremity function, determine its effect on prognosis, hospital admission, hospitalization, and mortality, and examine the results according to the…
- Conditions
- Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronisation Therapy (CRT), Reduced Ejection Fraction Heart Failure
- Trial name
- NCT07253909
- Testing
- Not applicable- observational study
- Where
- Turkey (Türkiye)
- Volunteers
- 72 people
- Sponsor
- Hacettepe University
Infection
Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics
Following previous positive experience with regulated CITA-RNPT of infected CIEDs, we suggest increasing the number of recruited patients and that CITA-RNPT can be administered prophylactically to patients prior to replacement of…
- Trial name
- NCT01770067
- Testing
- CITA-RNPT, Extraction of infected CIED
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Hillel Yaffe Medical Center
Postoperative Care After Cardiac Implantable Electronic Device Implantation
Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement
This randomized controlled trial will evaluate the effects of short-term medical arm sling use during the first 24 hours after cardiac implantable electronic device (CIED) implantation on patient comfort, pain, satisfaction, and…
- Trial name
- CIED-SLING24 (NCT07810426)
- Testing
- Medical Arm Sling
- Volunteers
- 104 people
- Sponsor
- Tugba Yorulmaz
Heart Failure, Left Bundle-Branch Block
Tailor-CRT: Better Application of Cardiac Resynchronization Therapy
Approximately one third of patients treated with cardiac resynchronization therapy (CRT) do not derive any clinical benefit. CRT response can be improved by tailoring LV lead placement and programming of atrio-ventricular (AV)…
- Trial name
- NCT02326493
- Testing
- Cardiac Resynchronization Therapy
- Where
- Netherlands
- Volunteers
- 28 people
- Sponsor
- Maastricht University Medical Center
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Left Bundle-Branch Block
Optimised MultiSite Pacing Vector Study
The objective of this clinical investigation is to evaluate the clinical benefits of an MultiSite pacing (MSP) with patient specific left ventricular vector optimization in patients receiving cardiac resynchronization therapy…
- Conditions
- Heart Failure, Left Bundle-Branch Block, Systolic Dysfunction
- Trial name
- NCT03938090
- Testing
- Optimised MultiSite Pacing, Standard biventricular pacing
- Where
- United Kingdom
- Sponsor
- Barts & The London NHS Trust
Heart Failure
CRT RENEWAL Registry
This registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decompensation, heart failure…
- Trial name
- NCT00146874
- Testing
- cardiac resynchronization therapy
- Volunteers
- 1,000 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
Deutsches Device Qualitätsregister
It is the aim of this register to document the development of therapies by implantation of Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.
- Trial name
- NCT01173783
- Where
- 7 sites in Germany
- Volunteers
- 4,008 people
- Sponsor
- Stiftung Institut fuer Herzinfarktforschung
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
Clinical Investigation of the Medtronic Concerto™ Device
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00268320
- Testing
- Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator
- Where
- 51 sites in United States, Austria and 10 more
- Volunteers
- 270 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study
The Cutaneous Heart Sounds Data Collection During CRT Optimization study is an acute, prospective, non-randomized multi-center feasibility clinical trial.
- Trial name
- NCT01609985
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Anxiety, Pain
Impact of Virtual Reality on Anxiety and Pain During Implantation of Cardiac Implantable Electronic Devices (CIED)
Purpose: This study aimed to evaluate whether virtual reality technology positively affects patients' pain and anxiety throughout the entire procedure of implantation of cardiac pacemakers, defibrillators, or cardiac…
- Trial name
- CIED (NCT07250282)
- Testing
- Virtual reality headset
- Where
- Germany
- Volunteers
- 111 people
- Sponsor
- Muhammed Kurt
Hematoma Postoperative, Cardiac Resynchronization Therapy Devices
Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices
As the number of implanted cardiovascular implanted electronic devices (CIEDs) increases, the incidence of their complications also grows.
- Conditions
- Hematoma Postoperative, Cardiac Resynchronization Therapy Devices, Compression Bandages
- Trial name
- NCT04389398
- Testing
- pocket compression fixation belt
- Volunteers
- 80 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Heart Failure With Intraventricular Conduction Delay
A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.
Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy.
- Trial name
- NCT02247817
- Testing
- Hybrid CRT-D/P implantation
- Volunteers
- 10 people
- Sponsor
- University Medical Center Groningen
LVAD (Left Ventricular Assist Device) Driveline Infection
Effect of Cardiac Resynchronization Therapy (CRT) on Left Ventricular Assist Device (LVAD) Function
Certain patients with congestive heart failure are treated both by implantation of an LVAD, as well as implantation with a biventricular pacemaker.
- Trial name
- NCT04153786
- Testing
- Temporary changes in an already-implanted medical device (biventricular pacemaker)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of California, Davis
Chronic Heart Failure
Interactive Patient's Assistant - LUCY
Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD).
- Trial name
- NCT03474315
- Testing
- Multivariate assessment
- Where
- Poland
- Volunteers
- 600 people
- Sponsor
- Medical University of Warsaw