Clinical trials: Pacemaker-Induced Cardiomyopathy
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
Atrial Fibrillation (AF), Pacemaker Therapy
Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF
This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate…
- Conditions
- Atrial Fibrillation (AF), Pacemaker Therapy, Atrioventricular Block, Preserved Ejection Fraction
- Trial name
- LBBP-AHRE (NCT07250529)
- Testing
- Right Ventricular Pacing, Left Bundle Branch Pacing
- Where
- Greece
- Volunteers
- 244 people
- Sponsor
- University Hospital of Patras
Heart Failure, Dilated Cardiomyopathy
PITA-HF: Feasibility, Safety, and Tolerability
Heart failure affects over 25 million people worldwide and nearly 7 million adults in the United States alone. Nearly 25% of patients with heart failure have worsened disease burden from dyssynchronous ventricular contraction due…
- Trial name
- NCT04159454
- Testing
- PITA
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Johns Hopkins University
Conduction System Pacing, Conventional Ventricular Pacing
Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
The implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.
- Trial name
- PHYSPAVB (NCT05214365)
- Testing
- Pacemaker implantation and conventional cardiac pacing, Conduction system pacing implant
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- Hospital Clinic of Barcelona
Pacing-Induced Cardiomyopathy
Effect of Leadless Pacing on Heart Function
This prospective, un-blinded, randomized, noninferiority, single centre study with 12 month follow-up included patients who were scheduled for a single-chamber PM implant.
- Trial name
- NCT06100757
- Testing
- Micra Transcatheter Pacing System (TPS°, Conventional pacemaker type Medtronic Advisa ADSR03 or Azure XT VR
- Where
- Belgium
- Volunteers
- 51 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Pacemaker Complication
A Major Determinant Focused on the ECG or Echocardiogram for PICM and Its Clinical Outcome (PICM Syndrome)
Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM).
- Trial name
- NCT03475498
- Where
- 3 sites in South Korea
- Volunteers
- 1,000 people
- Sponsor
- Eulji University Hospital
Heart Failure, Pacemaker-Induced Cardiomyopathy
The PICM Risk Prediction Study - Application of AI to Pacing
Development of pacing induced cardiomyopathy (PICM) is correlated to a high morbidity as signified by an increase in heart failure admissions and mortality.
- Conditions
- Heart Failure, Pacemaker-Induced Cardiomyopathy, Pacemaker Complication
- Trial name
- NCT06449079
- Testing
- Machine learning
- Where
- 3 sites in United Kingdom
- Volunteers
- 10,000 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Pacemaker, Artificial, Cardiomyopathies
Genetic Basis of Pacing-induced Cardiomyopathy
The purpose of this study is to collect a saliva sample from patients with a pacemaker to study genes involved in cardiomyopathy, a condition where the heart muscle is abnormal.
- Trial name
- NCT03317964
- Testing
- Saliva sample
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- The Guthrie Clinic
Bradycardia, Heart Failure
LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy
LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant…
- Conditions
- Bradycardia, Heart Failure, Pacemaker-Induced Cardiomyopathy, Conduction Block, Atrioventricular
- Trial name
- LEAP-CAR (NCT05910866)
- Testing
- Left bundle branch area pacing (LBBAP), Right ventricular pacing (RVP)
- Where
- Italy
- Volunteers
- 130 people
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
Aortic Valve Stenosis, Heart Failure
Conventional Versus Left Bundle Branch Pacing in TAVI
This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left…
- Conditions
- Aortic Valve Stenosis, Heart Failure, Pacemaker-Induced Cardiomyopathy, Transcatheter Aortic Valve Implantation
- Trial name
- NCT05895097
- Testing
- Left bundle branch pacemaker, Conventional pacing
- Where
- Slovenia
- Volunteers
- 50 people
- Sponsor
- University Medical Centre Ljubljana
Atrioventricular Block, Second and Third Degree, Pacemaker-Induced Cardiomyopathy
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular…
- Conditions
- Atrioventricular Block, Second and Third Degree, Pacemaker-Induced Cardiomyopathy, Heart Failure
- Trial name
- STAY (NCT06026683)
- Testing
- Pacemaker implant
- Where
- Spain
- Volunteers
- 75 people
- Sponsor
- Parc de Salut Mar
Pacemaker DDD, Atrioventricular Block
Risk of Pacing-induced Cardiomyopathy
This study will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy.
- Conditions
- Pacemaker DDD, Atrioventricular Block, Pacing-Induced Cardiomyopathy
- Trial name
- NCT04269733
- Testing
- Right ventricular pacing
- Where
- Denmark
- Volunteers
- 153 people
- Sponsor
- Aalborg University Hospital
Pacing-Induced Cardiomyopathy, Heart Failure
Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing…
- Trial name
- PROTECT-UP (NCT06052475)
- Testing
- Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing), Continued RV Pacing (Right Ventricular Pacing)
- Where
- 12 sites in United Kingdom
- Volunteers
- 155 people
- Sponsor
- Imperial College London
Pacing-Induced Cardiomyopathy
Effect of Right Ventricle Lead Position on The Psychological Aspects of Patients With A Dual Chamber Pacemaker
The purpose of the current study was to determine the factors associated with increased levels of anxiety and depression both before and after pacemaker implantation and examine if changes in these symptoms occur during the first…
- Trial name
- NCT06008340
- Testing
- Dual chamber Pacemaker
- Where
- Egypt
- Volunteers
- 182 people
- Sponsor
- Kafrelsheikh University
Complete Heart Block, High Degree Second Degree Atrioventricular Block
Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement (Left Bundle BRAVE)
The purpose of the study is to investigate the superiority of chronic left bundle branch area pacing compared to traditional right ventricular (RV) septal pacing in patients with high-grade conduction disease after transcatheter…
- Conditions
- Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy, Aortic Valve Stenosis
- Trial name
- NCT05541679
- Testing
- Right ventricular septal pacing followed by left bundle branch area pacing, Left bundle branch area pacing followed by right ventricular septal pacing
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- Main Line Health
Cardiomyopathy, Hypertrophic
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most patients with hypertrophic cardiomyopathy (HCM).
- Trial name
- NCT00001530
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment…
- Conditions
- Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation, Right Ventricular Dysfunction
- Trial name
- LvL-PACE (NCT07534917)
- Testing
- Temporary left bundle branch area pacing, Temporary leadless right ventricular pacing
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
High Degree Second Degree Atrioventricular Block, Complete Heart Block
RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI
The RAFT-TAVR PACE study is a clinical trial designed to compare two types of heart pacing methods in patients who develop conduction problems after undergoing a transcatheter aortic valve replacement (TAVR) procedure.
- Conditions
- High Degree Second Degree Atrioventricular Block, Complete Heart Block, Heart Failure, Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- RAFT-TAVR PACE (NCT06857201)
- Testing
- Left Bundle Branch Area Pacing, Right Ventricular Pacing
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's