Clinical trials: AV-Block
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
Bradyarrhythmias, AV Block Complete
Belgo-Luxembourg Leadless PM Registry
This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott.
- Conditions
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1, Pacemaker
- Trial name
- BELLA (NCT07879716)
- Testing
- CT scan heart, 24 hour ambulatory ECG monitoring
- Where
- 9 sites in Belgium, Luxembourg
- Volunteers
- 190 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Leadless Pacemaker, Bradycardia
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI/VDD) according…
- Conditions
- Leadless Pacemaker, Bradycardia, AV Block, Cardiac Rhythm Disorder
- Trial name
- BIO-LivIQ (NCT07118358)
- Testing
- LivIQ Leadless Pacemaker System
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 325 people
- Sponsor
- Biotronik, Inc.
Bradycardia Sinus, AV Block
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location.
- Conditions
- Bradycardia Sinus, AV Block, Atrial Fibrillation (AF)
- Trial name
- NCT06910059
- Testing
- Observational
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Transcatheter Aortic Valve Implantation, Physiological Pacing
Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI
Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF> 50%, that aims to study the percentage of patients who improve at 12 months in a combined…
- Conditions
- Transcatheter Aortic Valve Implantation, Physiological Pacing, Right Ventricular Pacing, AV Block
- Trial name
- PHYSTAVIII (NCT06197503)
- Testing
- Conduction system pacing, Right ventricular pacing
- Where
- Spain
- Volunteers
- 48 people
- Sponsor
- Hospital Clinic of Barcelona
Brady-tachy Syndrome, Brady Arrythmia
ALPs Single ChambEr New Device Study
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Brady-tachy Syndrome, Brady Arrythmia, Bradycardia, AV Block
- Trial name
- ASCEND (NCT07469579)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 15 people
- Sponsor
- Cairdac SA
Bradycardia, Brady-tachy Syndrome
ALPs Single ChambEr New Device
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
- Conditions
- Bradycardia, Brady-tachy Syndrome, AV Block, Atrial Fibrillation (AF)
- Trial name
- ASCEND (NCT07461935)
- Testing
- Leadless ventricular pacemaker implantation
- Volunteers
- 10 people
- Sponsor
- Cairdac SA
AV Block Complete, AV Block-2Nd Degree-Type 1
Efficacy and Safety of Micra AV2 Transcatheter Pacing System
A third generation, Micra AV2 is now available and proposes increased automaticity and improved AV synchrony algorithms based on computing model.
- Conditions
- AV Block Complete, AV Block-2Nd Degree-Type 1, AV Block
- Trial name
- EMAV2 (NCT07356505)
- Testing
- Implant procedure of a Micra AV2 leadless pacemaker (Medtronic)
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Heart Failure, Heart Failure With Reduced Ejection Fraction
Left vs Left Randomized Clinical Trial
The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality)…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, AV Block, LBBB
- Trial name
- NCT05650658
- Testing
- His/LBBP, BiVP
- Where
- 71 sites in United States, Canada
- Volunteers
- 2,136 people
- Sponsor
- Baylor College of Medicine
Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS
POLish Registry of CArdioneuroablation and CArdioneuromodulation
The multicentre observational study POL-CA involves a wide spectrum of patients with a history of syncopy. The study recruits patients with diagnosed vasovagal syndrome, cardioinhibitory carotid sinus syndrome, symptomatic sinus…
- Conditions
- Vasovagal Syndrome VVS, Cardioinhibitory Carotid Sinus Syndrome CSS, Symptomatic Sinus Bradycardia SB or Atrioventricular Block AV, Postural Orthostatic Tachycardia Syndrome POTS
- Trial name
- POL-CA (NCT07196397)
- Testing
- cardioneuroablation, SN sparing hybrid ablation, Cardiac sympathetic denervation
- Where
- Poland
- Volunteers
- 1,000 people
- Sponsor
- SABAMED Medical Center Ltd.
Vasovagal Syncope, AV Block-2Nd Degree-Type 1
Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry
The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency…
- Conditions
- Vasovagal Syncope, AV Block-2Nd Degree-Type 1, Sinus Pause
- Trial name
- CNA-FWRD (NCT06166277)
- Testing
- Ablation procedure
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Rush University Medical Center
Cardiac Arrhythmia, Heart Failure
Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants
The study will include patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation.
- Conditions
- Cardiac Arrhythmia, Heart Failure, AV Block
- Trial name
- TUFF (NCT04867460)
- Testing
- Ultrasound guided venous access
- Where
- Sweden
- Volunteers
- 58 people
- Sponsor
- Region Skane
Sinus Node Dysfunction, Heart Block AV
The Fluoroless-CSP Trial Using Electroanatomic Mapping
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster…
- Conditions
- Sinus Node Dysfunction, Heart Block AV, LBBB, Heart Failure, Systolic
- Trial name
- NCT03903107
- Testing
- Conventional fluoroscopy guided Conduction System Pacing(CSP), Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Rush University Medical Center
Heart Failure, AV Block
Synchrony in Cardiac Conduction: Assessing the Effects of Pacing on Cardiac Performance Through Magnetic Resonance Imaging and Advanced ECG-imaging
Rationale Right ventricular pacing (RVP) is an established and effective therapy for patients with atrioventricular (AV) block. However, frequent RVP has been associated with left ventricular (LV) dyssynchrony and may progess…
- Trial name
- HARMONY (NCT06843135)
- Testing
- Ventricular pacing
- Volunteers
- 88 people
- Sponsor
- Amsterdam UMC, location VUmc
AV Block
Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction
Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block.
- Trial name
- STAY II (NCT06707662)
- Testing
- Pacemaker and defibrillator
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Parc de Salut Mar
AV Block Complete, Tricuspid Regurgitation (TR)
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear.
- Trial name
- NCT06814574
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Heart Block AV
Micra AV Tracking During Exercise Testing
The purpose of this study is to determine the effectiveness of the Micra AV 2.0 device during exercise or elevated heart rates. Participation in research studies is voluntary.
- Trial name
- NCT05966168
- Testing
- Medtronic Micra AV Device
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Duke University
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
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