Clinical trials: Pacemaker, open to volunteers
Tricuspid Regurgitation, CIED Implantation
3D Transthoracic Echocardiographic Evaluation on Tricuspid Regurgitation Progression and Clinical Outcomes in Patients With Cardiac Implantable Electronic Device
The goal of this observational study is to learn about the development and worsening of tricuspid regurgitation (TR) in patients who have cardiac implantable electronic devices (CIEDs).
- Conditions
- Tricuspid Regurgitation, CIED Implantation, Leadless Pacemaker, Pacemaker
- Trial name
- 3DECHO-TR (NCT07793916)
- Testing
- 3D Transthoracic echocardiographic evaluation
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Samsung Medical Center
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
Leadless Pacemaker
Aveir Leadless Pacemaker Japan PMS
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing.
- Trial name
- NCT07106788
- Testing
- Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients, Upgrades
- Where
- 14 sites in Japan
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices
Cardiac Amyloidosis, Pacemaker
Increased Pacemaker Lower Rate in ATTR Cardiac Amyloidosis
In cardiac amyloidosis, the heart muscle becomes thick and stiff, making it difficult to pump enough blood with each beat. The heart also often cannot increase its stroke volume, making patients with cardiac amyloidosis more…
- Trial name
- PACE-ATTR (NCT07413081)
- Testing
- Increasing the pacemaker lower rate, Standard setting
- Where
- 9 sites in Denmark, Sweden
- Volunteers
- 34 people
- Sponsor
- Region Skane
Vascular Closure, Pacemaker Implantation
Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.
The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker…
- Conditions
- Vascular Closure, Pacemaker Implantation, Leadless Pacemaker
- Trial name
- PERCLOSE-LP (NCT06837870)
- Testing
- percutaneous suture mediated closure, Figure of Eight Suture
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Massachusetts, Worcester
Atrial Arrhythmia, Atrial Tachycardia
ATrial Tachycardia PAcing Therapy in Congenital Heart
Congenital heart disease (CHD) affects approximately 1% of newborns in the US, with 25% of those affected having critical conditions requiring open heart surgery within one year of birth.
- Conditions
- Atrial Arrhythmia, Atrial Tachycardia, Congenital Heart Disease, Pacemaker Re-Entrant Tachycardia
- Trial name
- AT-PATCH (NCT03209583)
- Testing
- Medtronic
- Where
- 15 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- Ian Law
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
Shoulder Injuries
Rehabilitation With the Shoulder Pacemaker
The investigators purpose of the proposed study is to use the FDA approved Shoulder Pacemaker device in patients undergoing reverse shoulder arthroplasty and study the functional outcomes compared to a standard post-operative…
- Trial name
- NCT06501859
- Testing
- Standard of care physical therapy, Shoulder pacemaker with physical therapy
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Utah
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
Tricuspid Regurgitation, Pacemaker
Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes
Tricuspid regurgitation (TR) is a common complication following cardiac implantable electronic device (CIED) implantation, with severe TR being associated with increased rates of heart failure hospitalization and all-cause…
- Trial name
- NCT06922526
- Testing
- Pacemaker implantation
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Haiyan Wang
Syncope, Pacemaker
Syncope-Asystole Latency Time in Tilt Table Test: The SALT-TILT Study
Syncope is a common presenting condition. Pacemaker implantation can significantly reduce syncope recurrences in reflex syncope.
- Conditions
- Syncope, Pacemaker, Asystole, Neurally Mediated Syncope
- Trial name
- SALT-TILT (NCT06356207)
- Testing
- Tilt Table Test
- Where
- Italy
- Volunteers
- 64 people
- Sponsor
- Azienda Ospedaliera di Bolzano
Atrioventricular Block, Second and Third Degree
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic…
- Trial name
- PACE-4-TAVI (NCT05966675)
- Testing
- conduction system pacing, right ventricular or biventricular pacing
- Where
- Poland
- Volunteers
- 500 people
- Sponsor
- Medical University of Silesia
Patients Above 18 Years, Patient Discharge
One Year Pacing Dependency After TAVR
Pace maker implantation after the procedure of TAVR can be estimated at 15% of patients. However, some studies have shown that the conduction disturbances after TAVR could resolve over time, and that roughly between one- and…
- Conditions
- Patients Above 18 Years, Patient Discharge, Pacing Therapy, Aortic Stenosis (Treated With TAVI)
- Trial name
- PACETAVI (NCT06756282)
- Testing
- Pacemaker and defibrillator
- Where
- France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Montpellier
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.
Leadless Pacemaker, Transthoracic Echocardiography
Ultrasound Guided Leadless Pacemaker Implantation
The leadless pacemaker is a novel pacing technology that has emerged in recent years. Compared with conventional lead pacemakers, its design avoids many complications associated with leads and pacemaker pockets, including lead…
- Trial name
- NCT07857330
- Testing
- Transthoracic echocardiography-guided, Conventional fluoroscopy-guided, Leadless pacemkaer
- Volunteers
- 288 people
- Sponsor
- China National Center for Cardiovascular Diseases
Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and…
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree, Heart Failure
- Trial name
- CIED-CARE (NCT06652750)
- Testing
- Routine Management, 5G Cloud Follow-up
- Where
- 2 sites in China
- Volunteers
- 688 people
- Sponsor
- The Third People's Hospital of Chengdu
Pacemaker, Conduction System Pacing
Fluoroless Conduction System Implant
Conduction system pacing is a new way of stimulating the heart using pacemaker wires. Traditional pacemakers stimulate the heart muscle which causes disordered heart beats: the walls of the heart move at different times.
- Trial name
- NCT07094217
- Volunteers
- 75 people
- Sponsor
- Imperial College London
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
Heart Failure
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.
- Trial name
- DANLOGIC-HF (NCT06099158)
- Testing
- HeartLogic
- Where
- Denmark
- Volunteers
- 1,428 people
- Sponsor
- Tor Biering-Sørensen
Atrial Fibrillation, Heart Failure
RAFT - Pace &Ablate
Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs.
- Conditions
- Atrial Fibrillation, Heart Failure, Pacemaker, Arrhythmia Atrial
- Trial name
- RAFT-P&A RCT (NCT06299514)
- Testing
- Pace and Ablate, Medication
- Where
- 12 sites in Canada
- Volunteers
- 600 people
- Sponsor
- Habib Khan