Clinical trials: Left Bundle Branch Area Pacing
Heart Failure - NYHA II - IV, Left Bundle Branch Area Pacing
REstoration of SYNChronous Cardiac Function Due to Physiologic cArdiac Pacing Modalities With Clinical Endpoints
The goal of this observational study is to evaluate the long-term clinical outcomes of physiologic cardiac resynchronization therapy (CRT) using conduction system pacing strategies compared with conventional biventricular CRT in…
- Conditions
- Heart Failure - NYHA II - IV, Left Bundle Branch Area Pacing, Left Bundle Branch Block, Intraventricular Conduction Delay
- Trial name
- RESYNC-PACE (NCT07684547)
- Testing
- Physiologic cardiac resynchronization using conduction system pacing and selective LV lead optimization.
- Where
- Hungary
- Volunteers
- 50 people
- Sponsor
- University of Pecs
Pacemaker DDD, His Bundle Pacing
Pacing to Maintain Physiologic Ventricular Activation
Right ventricular pacing causes ventricular dyssynchrony and may be associated with impaired outcome. In the last decade, several approaches for more physiological pacing became available and were implemented in the latest…
- Conditions
- Pacemaker DDD, His Bundle Pacing, LBB Area Pacing, Pacing-Induced Cardiomyopathy
- Trial name
- Pace-Conduct (NCT04416958)
- Testing
- cardiac implantable electronic device (CIED) implantation
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Klinikum-Fuerth
Atrioventricular Block, Left Bunde Branch Area Pacing
Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fraction
Conventional right ventricular pacing (RVP) has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes.
- Conditions
- Atrioventricular Block, Left Bunde Branch Area Pacing, Conduction System Pacing
- Trial name
- NOVEL II (NCT07464041)
- Testing
- Left Bundle Branch Area Pacing, Right venticular pacing
- Where
- 4 sites in South Korea
- Volunteers
- 200 people
- Sponsor
- Samsung Medical Center
Bradycardia, Cardiac Resynchronization Therapy
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
- Conditions
- Bradycardia, Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Trial name
- POLARIS (NCT06453850)
- Testing
- Use of FLEXIGO delivery catheter
- Where
- 17 sites in France, Germany and 3 more
- Volunteers
- 216 people
- Sponsor
- MicroPort CRM
Atrioventricular Block, Cardiac Surgery
OPTImizing Lead Placement in Patients Requiring Pacemaker After Cardiac Surgery
Conventional right ventricular pacing has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes.
- Trial name
- OPTI-PACS (NCT07795541)
- Testing
- Left bundle branch area pacing, Conventional pacing strategy
- Volunteers
- 110 people
- Sponsor
- Sahlgrenska University Hospital
Symptomatic Bradycardia
Pacing Characteristics of a Conventional Bipolar
Study Title: Pacing characteristics of a conventional bipolar, active fixation pacing lead for left bundle branch area pacing in patients with symptomatic bradycardia Study Objectives: To characterize an approach for left bundle…
- Trial name
- NCT06011252
- Testing
- Solia S lead with any BIOTRONIK Pacemaker
- Where
- 5 sites in Taiwan
- Volunteers
- 134 people
- Sponsor
- Chang Gung Memorial Hospital
Heart Failure, CRT and/or ICD
Evaluation of Electrical and Hemodynamic Effects of Different Pacing Strategies in CRT Candidates
Heart failure patients with delayed electrical activation of the heart often benefit from cardiac resynchronization therapy (CRT). However, traditional CRT using biventricular pacing is not effective in all patients.
- Trial name
- NCT07032064
- Testing
- Sequential ventricular pacing at five sites
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Shanghai Zhongshan Hospital
Left Ventricular Ejection Fraction Less Then or Equal to 50percent
Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal
While cardiac resynchronization therapy remains the mainstay for advanced HF, it is not always feasible due to unfavorable anatomy of coronary sinus or pacing characteristics.
- Trial name
- NCT06148571
- Testing
- left bundle branch area pacing
- Where
- South Korea
- Volunteers
- 142 people
- Sponsor
- Seoul National University Hospital
Cardiac Pacing
Change of QRS Morphology and Electrophysiological Characteristics During Pacing Within the Interventricular Septum
Conduction system pacing (CSP), including His bundle pacing (HBP) and left bundle branch (LBB) pacing (LBBP), as a physiological pacing strategy, can achieve interventricular and/or intra-left ventricular mechanical…
- Trial name
- NCT05557006
- Testing
- left bundle branch pacing
- Where
- China
- Volunteers
- 50 people
- Sponsor
- General Hospital of Shenyang Military Region
Left Bundle Branch Area Pacing
Transesophageal Echocardiography in Conductive System Pacing in Pediatric Patients
The investigatorse will use the guidance of Intraprocedural three-dimensional transesophageal echocardiography (3D-TEE) for Left Bundle Branch Area Pacing (LBBAP) lead implantation in pediatric patients.
- Trial name
- NCT07882563
- Testing
- Left Bundle Branch Pacing
- Volunteers
- 56 people
- Sponsor
- Assiut 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
Atrioventricular Block, Left Bundle Branch Area Pacing
Left Bundle Branch Area Pacing in AVB Patients
Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony.
- Trial name
- NCT03851315
- Testing
- permanent left bundle branch area pacing
- Where
- China
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Fu Wai Hospital, Beijing, China
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
AV Block, Bundle-Branch Block
Outcomes and Safety of Various Conduction System Pacing Methods
The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.
- Conditions
- AV Block, Bundle-Branch Block, Atrial Fibrillation Rapid
- Trial name
- NCT04749836
- Testing
- His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing
- Where
- Slovenia
- Volunteers
- 150 people
- Sponsor
- University Medical Centre Ljubljana
Block Complete Heart, Atrial Fibrillation (AF)
Closed-Loop Stimulation in Left Bundle Branch Area Pacing
This prospective, single-center, crossover study evaluated the effects of closed-loop stimulation (CLS) compared with conventional accelerometer-based rate-adaptive pacing (VVIR) in patients with permanent atrial fibrillation…
- Conditions
- Block Complete Heart, Atrial Fibrillation (AF), Chronotropic Incompetence
- Trial name
- NCT07812935
- Testing
- Closed-Loop Stimulation, Accelerometer-Based VVIR Pacing
- Where
- Poland
- Volunteers
- 33 people
- Sponsor
- Bartlomiej Wrobel
Heart Failure, Left Bundle Branch Block
Clinical Efficacy and Safety of Left Bundle Branch Area Pacing Using Quantitative Guidance of Multimodal Data in the Treatment of Heart Failure
Heart failure is a common chronic cardiovascular disease that seriously impairs patients' quality of life and long-term prognosis.
- Conditions
- Heart Failure, Left Bundle Branch Block, Non-ischemic Cardiomyopathy
- Trial name
- NCT07814612
- Testing
- Apply multimodal data fusion for quantitative guidance of left bundle branch region pacing, Conventional Biventricular Pacing
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital of Nanchang University
Left Bundle-Branch Block, Heart Failure
The Left Bundle Cardiac Resynchronization Therapy Trial
Cardiac resynchronization therapy (CRT) via biventricular (BiV) pacing significantly reduces morbidity and mortality in patients with left bundle branch block (LBBB), impaired LV function and heart failure in spite of optimal…
- Conditions
- Left Bundle-Branch Block, Heart Failure, Impaired Left Ventricular Function
- Trial name
- NCT05434962
- Testing
- Cardiac resynchronization therapy
- Where
- 10 sites in Spain
- Volunteers
- 176 people
- Sponsor
- Óscar Cano Pérez
Tachyarrhythmia
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD…
- Trial name
- NCT04863664
- Testing
- Defibrillation (RV Implant), Defibrillation (LBBAP Implant)
- Where
- 55 sites in United States, Australia and 18 more
- Volunteers
- 998 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia, Left Bundle Branch Area Pacing
Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead…
- Conditions
- Bradycardia, Left Bundle Branch Area Pacing, Cardiac Resynchronisation Therapy (CRT), ECG
- Trial name
- LBBOT (NCT07254013)
- Testing
- LBBAP implant
- Where
- 4 sites in France
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
Bradycardia, Left Bundle Branch Area Pacing
Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.
- Conditions
- Bradycardia, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
- Trial name
- STARLIGHT (NCT07342608)
- Testing
- Use of LINEA cardiac pacing lead
- Where
- 14 sites in Belgium, France and 3 more
- Volunteers
- 450 people
- Sponsor
- MicroPort CRM