Clinical trials: Pacemakers, Heart Failure
Left Ventricular Function Systolic Dysfunction
Pacemaker Upgrade to Cardiac Resynchronisation Therapy in Patients With Left Ventricular Dysfunction Dependant Upon Right Ventricular Pacing
Patients with pacemakers often have undiagnosed heart muscle weakness. When a pacemaker battery has run down, it is easily replaced by a short procedure.
- Trial name
- PRE-Empt (NCT01652248)
- Testing
- Cardiac resynchronisation therapy
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- University of Leeds
Heart Failure
Trial in Cardiac Resynchronization Therapy (CRT): Right Ventricular Apex Versus High Posterior Septum
In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker.
- Trial name
- NCT01035489
- Testing
- CRT in heart failure; Right ventricular apex v.s. high posterior septum
- Where
- Norway
- Volunteers
- 85 people
- Sponsor
- Haukeland University Hospital
Atrial Fibrillation (AF), Heart Failure - NYHA II - IV
Cardiovascular Performance and Exercise Response in Patients With Persistent or Permanent Atrial Fibrillation and Heart Failure Pre and Post Cardioversion or Pace and Ablate
Heart Failure (HF) and Atrial Fibrillation (AF) are two conditions that commonly occur together. Clinical guidelines consider a resting heart rate of 100-110 beats per minute (bpm) acceptable for patients with HF and AF while 72…
- Conditions
- Atrial Fibrillation (AF), Heart Failure - NYHA II - IV, Pacemaker, Cardioversion
- Trial name
- CPEX-CPA (NCT07205679)
- Volunteers
- 40 people
- Sponsor
- Habib Khan
Heart Failure
Cardiac Resynchronization in the Elderly
This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State University, and the VA Pittsburgh Healthcare…
- Trial name
- NCT03031847
- Testing
- Cardiac Resynchronization Therapy Pacemaker, Cardiac Resynchronization Therapy Defibrillator
- Where
- 6 sites in United States
- Volunteers
- 102 people
- Sponsor
- Samir Saba
Left Bundle Branch Pacing, Heart Failure
Left Bundle Branch Area Pacing 3D Guidance System
The investigator's project proposes the development of a 3D hybrid guidance system which has the aim of avoidance of scar and septal perforation through targeted lead deployment via a personalised septal real time image overlay…
- Conditions
- Left Bundle Branch Pacing, Heart Failure, Bradycardia
- Trial name
- NCT06461715
- Testing
- Machine learning with artificial intelligence software program
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Heart Failure, Congestive, Cardiac Pacemaker, Artificial
Optivol Diagnostic Data for Discharge in Heart Failure
The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance recorded by implantable cardiac devices can be used in conjunction with other traditional clinical…
- Trial name
- 3DHF (NCT00420108)
- Where
- 5 sites in United States
- Volunteers
- 23 people
- Sponsor
- Thomas Jefferson University
Heart Failure
Effect of Right Bifocal Ventricular Cardiac Pacing on Serum Level Natriuretic Peptides in Patients With Heart Failure
In this study we will select twenty patients with chronic atrial fibrillation and ventricular dysfunction with permanent cardiac pacemaker indication.
- Trial name
- NCT02186314
- Testing
- Pacemaker Biotronik: apical stimulation, Pacemaker Biotronik: bifocal stimulation
- Where
- Brazil
- Volunteers
- 20 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Cardiac Pacemaker Malfunction, ICD Malfunction
Perioperative Management Evaluation in Patients With CIED
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
- Conditions
- Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication
- Trial name
- EVINCE (NCT04331249)
- Testing
- surgery or catheter based cardiac procedure (catheter ablation)
- Where
- 2 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Klinikum-Fuerth
Congestive Heart Failure, Medical Device
Use of Defibrillator Information in the Emergency Department
This is a study to determine the feasibility of obtaining information stored in existing Medtronic internal defibrillators in patients who present to the Emergency Department(ED) for any reason.
- Trial name
- NCT00708058
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Ohio State University
Pacemaker, Diastolic Dysfunction
Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
Recent exploratory studies suggest that pacemaker patients with diastolic dysfunction (DD) or heart failure with preserved ejection fraction (HFpEF) may benefit from a higher backup heart rate (HR) setting than the factory…
- Conditions
- Pacemaker, Diastolic Dysfunction, Diastolic Heart Failure
- Trial name
- myPACE (NCT04721314)
- Testing
- Adjustment of lower rate limit, Maintenance of lower rate limit
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- University of Vermont
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
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
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
Bradycardia, Heart Failure
Eluna Family / Sentus BP Master Study
The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna pacemaker family and the Sentus BP (bipolar) left ventricular lead.
- Trial name
- NCT02059629
- Testing
- Eluna pacemaker family, Sentus BP lead
- Where
- 17 sites in Austria, Belgium and 3 more
- Volunteers
- 167 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT.
- Trial name
- TLC-AU (NCT06561932)
- Testing
- WiSE CRT System
- Where
- 4 sites in Australia
- Volunteers
- 40 people
- Sponsor
- EBR Systems, Inc.
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
- 5 sites in Denmark
- Volunteers
- 1,428 people
- Sponsor
- Tor Biering-Sørensen
Heart Failure
REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor
However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is…
- Trial name
- REMOTE-HEART (NCT06173089)
- Testing
- Remote monitoring
- Where
- Hungary
- Volunteers
- 800 people
- Sponsor
- Semmelweis University Heart and Vascular Center
Heart Failure, Congestive
HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
The literature shows that approximately 40% of individuals who receive a cardiac resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not have a clinical benefit from the device.
- Trial name
- NCT00370526
- Testing
- Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 100 people
- Sponsor
- Stereotaxis
Left Ventricular Dysfunction, Heart Failure, Systolic
Reprogramming to Prevent Progressive Pacemaker-induced Remodelling
The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.
- Conditions
- Left Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure, Pacemaker; Complication, Mechanical
- Trial name
- PPPR (NCT03627585)
- Testing
- Personalised programming
- Where
- 2 sites in United Kingdom
- Volunteers
- 91 people
- Sponsor
- University of Leeds
Heart Failure, Congestive
X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure
The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation (more than 80%); are eligible for the exchange of an old pacemaker or implantable…
- Trial name
- NCT00157846
- Testing
- CRT-P or CRT-D Device
- Where
- 10 sites in Germany
- Volunteers
- 36 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure