Clinical trials: Cardiac Resynchronization
Heart Failure
Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique
The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device.
- Trial name
- INTREPID (NCT00819117)
- Testing
- Cardiac Resynchronization Therapy implant
- Where
- 2 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Type 2 Diabetes Mellitus, Heart Failure
SGLT2i and Incretin and CRTd.
Incretin therapy and sodium-glucose- transporter2 inhibitors (SGLT2i) are a treatment for type 2 diabetes (T2DM) affected by heart failure (HF) and treated with cardiac resynchromization therapy (CRT).
- Trial name
- NCT03282136
- Testing
- Incretin Effect, Cardiac Resynchronization therapy defibrillator device, SGLT-2 inhibitor
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- University of Campania Luigi Vanvitelli
Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy
Electrical Resynchronization and Acute Hemodynamic Effects of Direct His Bundle Pacing Compared to Biventricular Pacing
The aims are to compare Direct His Bundle Pacing (DHBP) with biventricular pacing (BiV) in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using…
- Conditions
- Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy, Direct His Bundle Pacing
- Trial name
- NCT03452462
- Testing
- Pacing
- Where
- Switzerland
- Volunteers
- 19 people
- Sponsor
- University Hospital, Geneva
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
Ischemic Congestive Cardiomyopathy, Dilated Cardiomyopathy
Optimizing Left Ventricular Lead To Improve Cardiac Output
The purpose of this study is to determine if optimal lead placement, guided by the largest improvement in aortic flow measured by Doppler will: 1. Improve the way the heart's left ventricle functions 2.
- Conditions
- Ischemic Congestive Cardiomyopathy, Dilated Cardiomyopathy, Congestive Heart Failure
- Trial name
- CARE/VOLCANO (NCT01399801)
- Testing
- Doppler flow measurement, standard implantation of the LV lead
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Ann Marie Chikowski
Heart Failure
Sensor Optimization of Cardiac Resynchronization Therapy Response
The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a multicenter, prospective, non-randomized acute feasibility study that is being conducted to determine if subcutaneous heart sounds…
- Trial name
- SOCR (NCT01832493)
- Testing
- Cardiac Resynchronization Therapy
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates
The purpose of this study is to demonstrate that cardiac resynchronization therapy (CRT) responder rate can be improved by 3-dimensional (3D) echo-guided left ventricular (LV) lead placement compared to traditional LV lead…
- Trial name
- ENVISION (NCT01278030)
- Testing
- 3D echo-guided LV lead placement
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy
To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization…
- Trial name
- IRON-CRT (NCT03380520)
- Testing
- Ferric Carboxymaltose
- Where
- Belgium
- Volunteers
- 75 people
- Sponsor
- Hasselt University
Heart Failure, Branch Block, Bundle
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
Heart failure is a leading cause of morbidity and mortality. Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with symptomatic heart failure in spite of optimised medical treatment (OMT)…
- Trial name
- NCT03280862
- Testing
- Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator
- Where
- 5 sites in Denmark
- Volunteers
- 1,000 people
- Sponsor
- Aarhus University Hospital
Congenital Heart Defects
Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery
Malformations of the heart (congenital heart disease) are the most common congenital birth defects, occurring in about 1% of children.
- Trial name
- NCT00397514
- Testing
- Congenital Heart Surgery Patients
- Where
- Canada
- Volunteers
- 34 people
- Sponsor
- University of British Columbia
Heart Failure
Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.
- Trial name
- SMART CRT (NCT03089281)
- Testing
- CRT-D
- Where
- 72 sites in United States, Canada and 9 more
- Volunteers
- 699 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Systolic Heart Failure, Heart Failure With Reduced Ejection Fraction
Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-Response
This study aims to investigate whether the investigators can improve heart function in patients with heart failure who have undergone cardiac resynchronization therapy, but have not had an improvement in their heart function at…
- Conditions
- Systolic Heart Failure, Heart Failure With Reduced Ejection Fraction, CRT Non-Response, Left Bundle Branch Area Pacing
- Trial name
- NCT05884411
- Testing
- Left bundle branch area pacing, Cardiac MRI
- Where
- United States
- Sponsor
- VA Office of Research and Development
Heart Failure, Congestive
Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
Congestive heart failure (CHF) is a common health problem that leads to frequent hospitalizations and an increased death rate. In spite of advances in drug therapy, it remains a significant public health problem.
- Trial name
- RAFT (NCT00251251)
- Testing
- Optimal Medical Therapy plus ICD, Optimal Medical Therapy plus CRT/ICD
- Where
- 33 sites in Australia, Belgium and 5 more
- Volunteers
- 1,798 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Heart Failure, Atrial Arrhythmia
Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation (ReSync AF)
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
- NCT00268294
- Testing
- Cardiac Resynchronization Therapy
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure
The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device…
- Trial name
- NCT02698241
- Testing
- Diagnostic & Medication Management
- Where
- 8 sites in United States
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
CT Guided WiSE-CRT
This feasibility study will use CT scanning to identify the optimal location for placement of the WiSE-CRT system.
- Trial name
- NCT03495505
- Testing
- WiSE-CRT
- Where
- United Kingdom
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Heart Failure
Metabolic Mapping and Cardiac Resynchronization
The purpose of this study is to gather information on the safety and effectiveness of cardiac resynchronization therapy (CRT) in patients who have mild heart failure (HF) and left bundle branch block (LBBB).
- Trial name
- NCT03420833
- Testing
- Cardiac resynchronization therapy pacemaker (CRT-P)
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Yong-Mei Cha
Heart Failure
Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population.
- Trial name
- NCT00763698
- Testing
- QuickFlex Micro Model 1258T Left Heart Lead
- Where
- 13 sites in United States
- Volunteers
- 86 people
- Sponsor
- Abbott Medical Devices
Post Market Surveillance Study Following Clinical Routine
Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the performance of the Ingenio 2 CRT-P devices and to document that device-related events, device malfunctions or device deficiencies (DDs) do not…
- Trial name
- Rally CRT-P (NCT02488239)
- Testing
- CRT-P indicated patients
- Where
- 8 sites in Finland, Germany
- Volunteers
- 64 people
- Sponsor
- Boston Scientific Corporation
Cardiac Resynchronisation Therapy
AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
- Trial name
- AXONE-Acute-2 (NCT04156412)
- Testing
- Implant test procedure
- Where
- 7 sites in France, Spain
- Volunteers
- 39 people
- Sponsor
- University Hospital, Rouen