Clinical trials: Block, Heart
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrythmia
Aveir VR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05270499
- Testing
- Aveir VR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 3,427 people
- Sponsor
- Abbott Medical Devices
Cardiac Pacemaker, Arrythmia
Aveir DR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05935007
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 1,805 people
- Sponsor
- Abbott Medical Devices
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, 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
Left Ventricular Ejection Fraction, Heart Failure (HF)
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide…
- Conditions
- Left Ventricular Ejection Fraction, Heart Failure (HF), Left Bundle-Branch Block
- Trial name
- REINVENT (NCT05652218)
- Testing
- LB-CRT, BIV-CRT
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Inova Health Care Services
Cardiac Pacemaker, Arrhythmias, Cardiac
The Leadless AV Versus DDD Pacing Study
Cardiac pacemaker (PM) implantation is the established treatment for relevant bradyarrhythmias. Conventional PMs require 1-3 pacing leads to register the heart's intrinsic activity ("sensing") and to deliver the electrical…
- Conditions
- Cardiac Pacemaker, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
- Trial name
- LEAVE DDD (NCT05498376)
- Testing
- Conventional pacemaker DDD, Leadless pacemaker Micra AV
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
AV Block
Danish Randomized Trial on Leadless vs Transvenous Pacing
The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block.
- Trial name
- DANVERS (NCT05856799)
- Testing
- Leadless Micra AV Transcatheter Pacing System, Transvenous Azure XT DR dual chamber pacemaker
- Where
- 2 sites in Denmark
- Volunteers
- 80 people
- Sponsor
- University of Aarhus
Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Open-heart Surgery
Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Open-Heart Surgery
Postoperative pain following open-heart surgery is a significant challenge that may negatively affect recovery and overall clinical outcomes.
- Trial name
- NCT07232992
- Testing
- SPSIPB blcok, Parasternal blocks, Local Infiltration
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people
- Sponsor
- Bursa City Hospital
Heart Valvular Disease, Minimally Invasive Cardiac Surgery
SPSIP Block and Opioid Use After MICS
This prospective, randomized, controlled, single-center clinical study aims to evaluate the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in perioperative pain management among patients…
- Conditions
- Heart Valvular Disease, Minimally Invasive Cardiac Surgery, Postoperative Pain Management, Serratus Posterior Superior Intercostal Plane Block
- Trial name
- SPSIPB-MICS (NCT07259824)
- Testing
- Serratus Posterior Superior Intercostal Plane Block (SPSIPB)
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Ankara City Hospital Bilkent
Heart Failure and Reduced Ejection Fraction
Evaluation of Accelerated Bachmann Bundle Area Pacing in Heart Failure With Reduced ejectIon Fraction Who Have electrocarDioGraphic Evidence of Interatrial Block and Indicated for Implantable Cardioverter Defibrillator
To evaluate the effect of accelerated atrial resynchronization achieved through Bachmann bundle pacing at the time of implantable cardioverter-defibrillator implantation in patients with heart failure with reduced ejection…
- Trial name
- BRIDGE-HF (NCT07547306)
- Testing
- BBAP on, BBAP off, RAAP
- Volunteers
- 120 people
- Sponsor
- Seoul National University Hospital
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
TAVI(Transcatheter Aortic Valve Implantation), Remote Monitoring
Remote ECG Monitoring Post TAVI
The DRAGON TAVI study is a multicenter, prospective, open, randomised trial, which will enrol 250 patients, randomized 1:1 to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and standard…
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Remote Monitoring, Arrythmia, Atrial Fibrillation (AF)
- Trial name
- DRAGON-TAVI (NCT07521800)
- Testing
- Remote ECG monitoring, Standard Care (in control arm)
- Where
- 4 sites in Italy, Poland
- Volunteers
- 250 people
- Sponsor
- Medical University of Silesia
Pregnancy-Associated Heart Disease, Fetal Congenital Heart Disease
Maternal-Fetal Heart Sound/Electrocardiogram Monitoring and Cardiac Risk Early Warning
This is a prospective observational cohort study conducted at Beijing Anzhen Hospital. The study aims to establish reference ranges of heart sound and electrocardiogram (ECG) parameters for both mothers and fetuses.
- Conditions
- Pregnancy-Associated Heart Disease, Fetal Congenital Heart Disease, Autoimmune-Related Fetal Heart Block, Perinatal Adverse Events
- Trial name
- NCT07526662
- Where
- China
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Yihua He,MD
Fascial Plane Block, ICU Length of Stay
Postoperative Analgesia and Ventilation After Cardiac Surgery
Cardiac surgery performed via median sternotomy is associated with significant postoperative pain due to extensive tissue trauma, sternal bone healing, and mediastinal retraction.
- Conditions
- Fascial Plane Block, ICU Length of Stay, Mechanical Ventilation Duration, Oxygenation
- Trial name
- NCT07475884
- Testing
- conventional analgesic regimen, Fascial Plane Blocks
- Where
- Turkey (Türkiye)
- Volunteers
- 206 people
- Sponsor
- Bursa City Hospital
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
Hearth Failure With Reduced Ejection Fraction (HFrEF), Cardiac Resynchronisation Therapy (CRT)
THE RELATIONSHIP BETWEEN CARDIAC RESYNCHRONİZATION THERAPY RESPONSE IN HEART FAILURE PATIENTS AND YKL-40 LEVELS
Patients diagnosed with heart failure at our clinic who routinely undergo CRT implantation will be included in the study. This decision is independent of the study.
- Conditions
- Hearth Failure With Reduced Ejection Fraction (HFrEF), Cardiac Resynchronisation Therapy (CRT), Left Branch Bundle Block
- Trial name
- NCT07469137
- Where
- Turkey (Türkiye)
- Volunteers
- 51 people
- Sponsor
- Trakya University
Pacemaker DDD, Heart Block
Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF).
- Trial name
- NCT05015660
- Testing
- Left bundle branch pacing lead, Right ventricular active fixation lead
- Where
- Canada
- Volunteers
- 1,300 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Heart Failure, Left Bundle-Branch Block
Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With HFrEF and a Typical LBBB.
The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left…
- Trial name
- HIS-alt_2 (NCT04409119)
- Testing
- HIS/LBB pacing, LV pacing
- Where
- Denmark
- Volunteers
- 150 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Atrial Fibrillation, Atrioventricular Block, Second and Third Degree
Predicting Severe Cardiac Arrhythmias in the Perioperative Period Using AI-ECG
During the preoperative examination, in addition to the standard examination recommended before high-risk cardiac surgeries, a digital single-lead ECG is recorded using portable CardioQUARK devices.
- Conditions
- Atrial Fibrillation, Atrioventricular Block, Second and Third Degree, Sinus Node Dysfunction, Ventricular Tachycardia (VT)
- Trial name
- NCT07348991
- Testing
- digital single-channel ECG recording
- Volunteers
- 300 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University