Clinical trials: Cardiac Resynchronization Therapy Devices
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
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
Heart Failure
British Randomised Controlled Trial of Atrioventricular (AV) and Interventricular (VV) Optimisation (BRAVO)
Many patients who have cardiac resynchronisation therapy (a type of pacemaker) implanted for heart failure do not have the settings of their device optimised.
- Trial name
- BRAVO (NCT01258829)
- Testing
- Non-invasive haemodynamic optimisation, ECHO optimisation
- Where
- United Kingdom
- Volunteers
- 403 people
- Sponsor
- Imperial College London
Congestive Heart Failure
Multiparametric Heart Failure Evaluation in Internal Cardioverter Defibrillators (ICD) Patients
The Boston Scientific Energen family is capable of measuring the respiratory rate trend (RRT) on a daily basis and transmission of data via the Remote Monitoring technology.
- Trial name
- MULTITUDE-HF (NCT01501331)
- Testing
- CRTD or ICD (Energen)
- Where
- 2 sites in Italy
- Volunteers
- 180 people
- Sponsor
- University of Rome Tor Vergata
Congestive Heart Failure
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device.
- Trial name
- CLEPSYDRA (NCT00957541)
- Testing
- Paradym CRT + Physiological Diagnosis (PhD)
- Where
- United States
- Volunteers
- 520 people
- Sponsor
- ELA Medical, Inc.
Heart Failure, Arrhythmia
Nursing Therapeutics Education and Heart Failure (HF): a Study Protocol
Purpose: Heart Failure (HF) is a clinical multifactorial syndrome, it can cause arrhythmias for which international guidelines suggest the implantation of an implantable cardiac defibrillator (ICD).
- Trial name
- NEHF (NCT02425488)
- Testing
- Nursing therapeutics education
- Where
- 2 sites in Italy
- Volunteers
- 30 people
- Sponsor
- University of Turin, Italy
Heart Failure at NYHA Stage III or IV, Non Responders to Resynchronization
LVAD in Non Cardiac Transplant Candidates and Non Responders to Resynchronization
The prognosis for heart failure patients is bleak for the advanced stages of the disease, with a reported 6-month mortality rate of almost 50% in patients treated with chronic inotropic therapy.
- Conditions
- Heart Failure at NYHA Stage III or IV, Non Responders to Resynchronization, Non Candidates for Transplantation
- Trial name
- CHECKMATE (NCT01126944)
- Testing
- heart mate II
- Where
- 4 sites in France, Germany
- Sponsor
- Rennes University Hospital
Heart Failure, Cardiac Resynchronization Therapy
Comparative Study to Examine Whether Echocardiography Performed During Cardiac Resynchronization Therapy Device Implantation Can Improve the Response Rate
Empirical implantation of the left ventricular lead is the prevailing practice in cardiac resynchronization therapy device implantation.
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy, Echocardiography
- Trial name
- E-OPT (NCT01014000)
- Testing
- Empirical group, Echocardiography-guided approach
- Where
- China
- Sponsor
- Princess Margaret Hospital, Hong Kong
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
Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and…
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree, Heart Failure
- Trial name
- CIED-CARE (NCT06652750)
- Testing
- Routine Management, 5G Cloud Follow-up
- Where
- 2 sites in China
- Volunteers
- 688 people
- Sponsor
- The Third People's Hospital of Chengdu
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
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, ICD
Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds
Dr. Jonathan Hsu and Dr. Eric Adler are conducting a research study to find out more about how implantable cardiac defibrillator (ICD) settings can be adjusted to improve patient cardiovascular health and quality of life.
- Conditions
- Heart Failure, ICD, Chronotropic Incompetence
- Trial name
- CLASS (NCT02693262)
- Testing
- CLS Mode on Biotronik CRT-D, Accelerometer Mode on Biotronik CRT-D
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Cardiac Rhythm Disorder
3T MRI CIED Post-Approval Study
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure.
- Trial name
- NCT02969395
- Where
- 204 sites in United States, Belgium and 20 more
- Volunteers
- 41 people
- Sponsor
- Medtronic
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
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 Disease, Cardiovascular Disease
Remote Interrogation in Rural Emergency Departments
A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REM RED (NCT02421549)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Sponsor
- Abbott Medical Devices
Heart Failure With Reduced Ejection Fraction (HFrEF)
Correlation of Typical LBBB Mechanical Activation Pattern by 2D Strain Echocardiography With Acute GWE Improvement in Patients Receiving LBBp or Conventional BiVp for Cardiac Resynchronization Therapy (Echo LBBp)
The present study is a multicenter interventional non randomised study in patients requiring an implantable device for cardiac resynchronization therapy.
- Trial name
- ECHO-LBBp (NCT06689111)
- Testing
- Left bundle branch pacing lead, CRT with the standard method through cs
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- University Hospital of Patras
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
Heart Failure, Systolic
Effects of CRT Optimization as Assessed by Cardiac MR
Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical…
- Trial name
- NCT04763460
- Testing
- Programming of CRT device settings
- Where
- 2 sites in United States
- Sponsor
- Minneapolis Heart Institute Foundation