Clinical trials: Resynchronization Therapy, active
Heart Failure
Clinical Prospective ranDomized Trial to Evaluate the Non-inferiority of Left Bundle Branch Area Pacing Vs Cardiac ResynchronIzatioN Therapy With ECG guIded AV Optimization
Cardiac resynchronization therapy is the gold standard therapy for patients with advanced HF left ventricle dysfunction and large QRS.
- Trial name
- DA VINCI (NCT07107048)
- Testing
- Pacemaker and defibrillator
- Where
- Italy
- Volunteers
- 194 people
- Sponsor
- Leonardo Calò, MD
Atrial Fibrillation (AF)
Bachmann's Bundle Versus Right Atrial Appendage Pacing
Participants will be randomly assigned to one of two clinical treatment Arms, both of which are standard care procedures performed in the right atrium (RA): Arm A: Pacing from the Bachmann's Bundle (BB) in the right atrium (upper…
- Trial name
- BACH-RAP (NCT07874763)
- Testing
- Bachmann's Bundle Pacing, Right Atrial Appendage Pacing
- Where
- United States
- Volunteers
- 334 people
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Heart Failure
Image Supported Lead Placement in CRT
Cardiac resynchronization therapy (CRT) is an established pacemaker therapy for patients with symptomatic chronic heart failure, but is hampered by a non-response rate of 30-40%.
- Trial name
- ADVISE (NCT05053568)
- Testing
- CARTBox
- Where
- 7 sites in Netherlands
- Volunteers
- 130 people
- Sponsor
- UMC Utrecht
Heart Failure, Intraventricular Block
A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
BATTLE study has been designed as a prospective, multi-center, randomized, controlled trial. This study will enroll 83 patients with chronic heart failure accompanied by intraventricular block (NICD) over an estimated recruitment…
- Trial name
- BATTLE (NCT06061627)
- Testing
- LOT-CRT group, BiVP group
- Where
- China
- Volunteers
- 86 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Heart Failure, Cardiac Resynchronization Therapy
Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy
The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.
- Trial name
- ASTRAL-4LV (NCT04463641)
- Testing
- Implantation of the Axone 4LV Lead
- Where
- 21 sites in Austria, France and 5 more
- Volunteers
- 92 people
- Sponsor
- MicroPort CRM
Cardiac Resynchronization Therapy, Chronic Heart Failure
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from…
- Conditions
- Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block
- Trial name
- CRT-DRIVE (NCT05327062)
- Testing
- CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
- Where
- 13 sites in United States, Austria and 5 more
- Volunteers
- 150 people
- Sponsor
- XSpline S.p.A.
Arrhythmias, Cardiac, Atrioventricular Block
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical…
- Conditions
- Arrhythmias, Cardiac, Atrioventricular Block, Reduced Systolic Function, Atrial Fibrillation
- Trial name
- TREEBEARD (NCT06324682)
- Testing
- Cardiac pacing - Conventional RV pacing, Cardiac pacing - Conduction System Pacing, Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)
- Where
- 31 sites in Italy
- Volunteers
- 8,400 people
- Sponsor
- University Hospital of Ferrara
Left Bundle Branch Block, Left Bundle Branch Area Pacing
UHF ECG in LBBB and Response to CRT Prediction
The main objective of the project is to demonstrate that in patients with heart failure and QRS complex of nonRBBB morphology lasting over 130 ms, UHF-ECG can differentiate patients with trueLBBB from IVCD better than existing…
- Conditions
- Left Bundle Branch Block, Left Bundle Branch Area Pacing, Biventricular Pacing, Intraventricular Conduction Delay
- Trial name
- UHF BLOCK (NCT07057544)
- Testing
- LBBAP CRT device implantation, BVP-CRT
- Where
- Czechia
- Volunteers
- 200 people
- Sponsor
- Faculty Hospital Kralovske Vinohrady
Heart Failure With Reduced Ejection Fraction
Improving CRT Outcome With Non-Invasive Cardiac Mapping
The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement.
- Trial name
- ICONIC-M (NCT05564793)
- Testing
- Pre-implantation planning, Post-implantation assessment
- Where
- 11 sites in Netherlands, Portugal and 2 more
- Volunteers
- 330 people
- Sponsor
- EP Solutions SA
Heart Failure, Pacemaker DDD
Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
Left bundle branch block (LBBB) exists in about 25% of patients with congestive heart failure and is associated with worsened prognosis.
- Conditions
- Heart Failure, Pacemaker DDD, Cardiomyopathies, Heart Diseases
- Trial name
- NIME-CRT (NCT05868616)
- Testing
- Cardiac Resynchronization Therapy (CRT)
- Where
- Norway
- Volunteers
- 80 people
- Sponsor
- Oslo University Hospital
Atrial Fibrillation (AF), Heart Failure
LBBAP vs. CS Pacing for CRT in Permanent Atrial Fibrillation and Heart Failure (SYNC-AF)
This is a prospective, multicenter, randomized controlled trial comparing Left Bundle Branch Area Pacing (LBBAP)-based cardiac resynchronization therapy (CRT) with conventional coronary sinus (CS) lead-based CRT in patients with…
- Conditions
- Atrial Fibrillation (AF), Heart Failure, Cardiomyopathies
- Trial name
- SYNC-AF (NCT07560891)
- Testing
- Left Bundle Branch Area Pacing (LBBAP) for CRT, Coronary Sinus (CS) Lead-Based Biventricular CRT
- Volunteers
- 44 people
- Sponsor
- Yonsei University
Heart Failure
BBAP With CS Mapping Guidance
Study Title Efficacy and Safety of Coronary Sinus-Based Left Atrial Mapping for Guiding Atrial Lead Implantation Targeting Bachmann Bundle Capture in Cardiac Resynchronization Therapy Research Objectives This study intends to use…
- Trial name
- NCT07531368
- Testing
- CS mapping guidance, ECG guidance
- Volunteers
- 40 people
- Sponsor
- Shanghai Zhongshan Hospital
Non-ischemic Cardiomyopathy, Heart Failure
LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB
The present study will recruit 50 symptomatic non-ischemic cardiomyopathy (NICM) patients with left ventricular ejection fraction (LVEF) below 35% and complete left bundle branch block (CLBBB), who have not received complete…
- Conditions
- Non-ischemic Cardiomyopathy, Heart Failure, Left Bundle-Branch Block
- Trial name
- LIT-HF (NCT05572957)
- Testing
- Guideline-Directed Medical Therapy(GDMT), left bundle branch pacing combined with Guideline-Directed Medical Therapy(LBBP+GDMT)
- Where
- 6 sites in China
- Volunteers
- 50 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Heart Failure, Diabetes Mellitus, Type 2
BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure
The primary aim of the current study is a better understanding of the role of Type 2 Diabetes Mellitus (T2DM) in heart failure and, in particular, changes in cardiac metabolism, which may contribute to heart failure.
- Trial name
- BIO-2-HEART (NCT03323216)
- Testing
- 6-minute walk test, Study specific questionnaire, Blood collection
- Where
- Germany
- Volunteers
- 400 people
- Sponsor
- RWTH Aachen University
Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing
Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing
The recent development and market introduction of small diameter implantable defibrillation leads able to deliver left bundle branch area pacing (LBBAP) has opened the possibility of achieving cardiac resynchronization therapy…
- Trial name
- FORGE CSP (NCT07406737)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Caen
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
Non Ischemic Cardiomyopathy
Magnetic Resonance Imaging Based Risk Stratification for Defibrillator Implantation in Heart Failure Patients Requiring Cardiac Resynchronisation Therapy
This randomized study aimed to compare the efficacy of LBBP without defibrillator vs biventricular pacing with defibrillator (BiV-ICD/CRT-D) in patients with LB-NICM and left ventricular ejection fraction (LVEF) ≤35% risk…
- Trial name
- MADURAI CRT (NCT07791407)
- Testing
- left bundle branch pacing, Biventricular pacing with defibrillator
- Where
- India
- Volunteers
- 114 people
- Sponsor
- Velammal Medical College Hospital and Research Institute
CRT Non-Response, LBBB
Left Ventricular Myocardial Work for Predicting Response to CRT
This study aims to establish the normal reference values for left ventricular myocardial work in healthy Chinese adults and the influencing factors.
- Conditions
- CRT Non-Response, LBBB, HF - Heart Failure, Healthy Adult
- Trial name
- CARE-MW (NCT07319065)
- Testing
- Ultrasound machine
- Where
- 82 sites in China
- Volunteers
- 3,240 people, healthy volunteers welcome
- Sponsor
- First Hospital of China Medical University
Cardiac Resynchronization Therapy
WiCS-LV Post Market Surveillance Registry
This is an observational, prospective, non-randomized collection of defined clinical data under normal conditions of use for the WiCS-LV System, an implantable cardiac pacing system capable of delivering pacing energy to the left…
- Trial name
- NCT02610673
- Testing
- WiCS-LV System
- Where
- 3 sites in Denmark, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- EBR Systems, Inc.
Heart Failure, Block, Heart
Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or…
- Conditions
- Heart Failure, Block, Heart, Pacing-Induced Cardiomyopathy
- Trial name
- NCT06620705
- Testing
- Left bundle branch area pacing, Biventricular pacing
- Where
- 2 sites in Denmark, Netherlands
- Volunteers
- 34 people
- Sponsor
- srdpiers