Clinical trials: Pacemaker Implantation
Tunisian Patients Already Implanted With a TAVI
Tunisian Registry of Trans Catheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement.
- Trial name
- TAVI-TN (NCT06503965)
- Where
- Tunisia
- Volunteers
- 300 people
- Sponsor
- Les Laboratoires des Médicaments Stériles
Aortic Valve Stenosis, AV Block
Edwards SAPIEN 3 PPI Registry
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct (NCT03497611)
- Testing
- transcatheter valve implantation
- Where
- 4 sites in Germany
- Volunteers
- 1,000 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Heart Block, Aortic Stenosis
Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).
The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in…
- Conditions
- Heart Block, Aortic Stenosis, Bundle-Branch Block
- Trial name
- GLUCO-TAVR (NCT06076824)
- Testing
- Methylprednisolone
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital General Universitario de Alicante
Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System
Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.
- Conditions
- Complication of Cardiac Defibrillator, Disorder of Cardiac Pacemaker System, Venous Occlusion
- Trial name
- NCT02331511
- Testing
- Aspirin 80 mg daily, Clopidogrel 75 mg daily
- Where
- Iran
- Volunteers
- 100 people
- Sponsor
- Shahid Beheshti University of Medical Sciences
Pacemaker, Pain Management
Effect of Clinical Pharmacist Consultation on Pain Management
This study aims to evaluate the effects of clinical pharmacists' consultation on patients' pain management following Pacemaker implantation surgery.
- Trial name
- NCT06748482
- Testing
- Counseling
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Anwar Mohsen Naji Bin Ali Alhaj
Pacemaker, TAVI
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI).
- Conditions
- Pacemaker, TAVI, Risk Score
- Trial name
- TAVI PACER (NCT06542380)
- Testing
- TAVI, pacemaker
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- German Heart Institute
Pacemaker Implantation, Pain
Effect of Local Anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) Cream and Reduction in Dose, Pain and Intravenous Analgesic During Permanent Pacemaker Implantation
The investigators believe that the local anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) cream will lessen pain and reduce the need for anesthesia and analgesia, when implanting a permanent pacemaker.
- Trial name
- NCT02016976
- Testing
- EMLA Analgesic Cream, Dormicum 2.5 mg and Pethidine 25 mg
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Hillel Yaffe Medical Center
Cardiac Arrhythmias, Hemorrhage
Tapered Warfarin or Interrupted Warfarin With Heparin Bridging for Pacemaker or Defibrillator Implantation
Approximately 2 million patients in North America are currently treated with the blood thinner warfarin. These patients have every year more than 200,000 invasive procedures, for which warfarin must be stopped to avoid bleeding…
- Conditions
- Cardiac Arrhythmias, Hemorrhage, Thromboembolism
- Trial name
- PACEBRIDGE (NCT02094157)
- Testing
- Tapered warfarin regimen, Bridged regimen Low-molecular-weight heparin
- Where
- 2 sites in Canada
- Volunteers
- 173 people
- Sponsor
- McMaster University
Cardiac Pacing, Permanent Pacemaker Implantation
Ultrasound-Guided PECS II Block for Permanent Pacemaker Implantation
This single-center, prospective, randomized, controlled clinical trial aims to evaluate whether ultrasound-guided PECS II block, when added to standard local infiltration anesthesia, improves perioperative analgesia in patients…
- Conditions
- Cardiac Pacing, Permanent Pacemaker Implantation, Postoperative Pain
- Trial name
- PACE-PECS (NCT07739407)
- Testing
- Ultrasound-Guided PECS II Block, Standard Local Infiltration Anesthesia
- Volunteers
- 72 people
- Sponsor
- ferdi gülaştı
Amyloid Cardiomyopathy, Block, AV
Screening of ATTRwt in Patient With Advanced AV-Block Undergoing Pacemaker Implantation
The investigators will nationally investigate the prevalence of Transthyretin Amyloidosis wildtype (ATTRwt) in patients of ≥ 65 years with left ventricular hypertrophy who present with high degree atrioventricular block…
- Trial name
- ATTRAB (NCT05699044)
- Testing
- Amyloidosis screening (bloodtest, DPD-scintigraphy, potentially endomyocardial biopsy)
- Where
- Denmark
- Volunteers
- 170 people
- Sponsor
- Steen Hvitfeldt Poulsen
Atrial Arrhythmia, Atrial Fibrillation (AF)
Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.
This prospective observational study evaluates the burden of Atrial High-Rate Episodes (AHRE) in patients without a prior history of atrial fibrillation who undergo concurrent Bachmann Bundle Area Pacing (BBAP) and Left Bundle…
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation (AF), Pacemaker Implantation, Left Bundle Branch Pacing
- Trial name
- AHRE-BLAST (NCT07305194)
- Where
- Greece
- Volunteers
- 460 people
- Sponsor
- University Hospital of Patras
Hypertension
Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients
The purpose of this study is to test whether the A-V sequential pacing strategy shown to effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure acutely in patients with hypertension (systolic…
- Trial name
- NCT02382484
- Testing
- A dual chamber pacing system (BackBeat Medical)
- Where
- China
- Volunteers
- 19 people
- Sponsor
- BackBeat Medical Inc
Atrial Fibrillation, Congestive Heart Failure
His Bundle Recording From Subclavian Vein
His bundle pacing has been proposed as a superior alternative to standard right ventricular pacing. The purpose of this study is to investigate whether obtaining a His Bundle recording from the subclavian vein using a stylet…
- Trial name
- NCT04115735
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- TriHealth Inc.
Dysrhythmia, Cardiac, Heart Failure
Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans
Particularly in CRT (Cardiac Resynchronisation Therapy), limited accessibility of the coronary sinus along with its branches and the mismatch between the region of latest left ventricular (LV) contraction and an adequate…
- Conditions
- Dysrhythmia, Cardiac, Heart Failure, Pacemaker Electrode Infection, Hemodialysis-Induced Symptom
- Trial name
- VAPS (NCT03387488)
- Testing
- StingrayTM, Medtronic®
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- RWTH Aachen University
Congestive Heart Failure
Electrophysiological Optimization of Left Ventricular Lead Placement in CRT
The purpose of this study is to investigate if "optimal electrical resynchronization" achieved by targeting left ventricular lead placement to the myocardial region with the latest electrical activation combined with post-implant…
- Trial name
- ElectroCRT (NCT02346097)
- Testing
- Cardiac Resynchronization Therapy (St. Jude Qaudripolar LV lead)
- Where
- Denmark
- Volunteers
- 122 people
- Sponsor
- University of Aarhus
Aortic Valve Stenosis
Impact of Beta Blockers on TAVI (BETA-TAVI)
The BETA-TAVI trial is a prospective, investigator-initiated, multicenter, randomized, open-label, non-inferiority trial designed to evaluate the safety of continuing versus temporarily interrupting chronic beta-blocker therapy…
- Trial name
- BETA-TAVI (NCT05721170)
- Testing
- Beta blocker
- Where
- 2 sites in Cyprus, Greece
- Volunteers
- 348 people
- Sponsor
- National and Kapodistrian University of Athens
Conduction Disturbances, Transcatheter Aortic Valve Replacement
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients.
- Conditions
- Conduction Disturbances, Transcatheter Aortic Valve Replacement, Permanent Pacemaker Implantation
- Trial name
- PROMOTE (NCT04139616)
- Where
- Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Bradyarrhythmias, Arrhythmias
Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias
Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects.
- Conditions
- Bradyarrhythmias, Arrhythmias, Atrioventricular Block, Ventricular Dysfunction
- Trial name
- SAFE-LVPACE (NCT01717469)
- Testing
- Left ventricular pacing through coronary sinus tributaries (Attain StarFix), Right ventricular pacing (Medtronic)
- Where
- Brazil
- Volunteers
- 12 people
- Sponsor
- University of Sao Paulo
Aortic Stenosis
Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients
During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted. The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).
- Trial name
- PAMIT (NCT02768064)
- Testing
- temporary pacemaker insertion
- Volunteers
- 120 people
- Sponsor
- Hadassah Medical Organization
Left Bundle-Branch Block, Aortic Stenosis
Study on Heart Block Risks Using Outcome-Based Modeling
This study developed a prediction model for high-grade atrioventricular block (AVB) and complete left bundle branch block (CLBBB) following transcatheter aortic valve replacement (TAVR) in Chinese patients with aortic stenosis…
- Trial name
- SAVIOR (NCT07065123)
- Testing
- The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
- Volunteers
- 112 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University