Clinical trials: Pacemaker Therapy
Heart Failure
One Day Implantation Program for Heart Failure Patients Implanted With CRT-P
This study has been implemented to evaluate cardiac resynchronization therapy pacemaker (CRT-P) implantations on a same-day basis
- Trial name
- OEDIPE-CRT-P (NCT05142293)
- Testing
- Ambulatory procedure
- Where
- 19 sites in France
- Volunteers
- 354 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Congestive
Home Monitoring in Cardiac Resynchronisation Therapy
In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem.
- Trial name
- HomeCARE (NCT00376116)
- Testing
- Cardiac resynchronisation therapy, Implantable cardioverter-defibrillator
- Where
- 82 sites in Austria, Czechia and 8 more
- Volunteers
- 513 people
- Sponsor
- Biotronik SE & Co. KG
Heart Disease, Cardiovascular Disease
Remote Device Interrogation In The Emergency Department
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REMEDY (NCT01871090)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Congestive Heart Failure
PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Conditions
- Heart Failure, Congestive Heart Failure, Cardiomyopathy
- Trial name
- NCT00253357
- Where
- 28 sites in United States, Austria and 11 more
- Volunteers
- 450 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachyarrhythmia
APART: Prevention and Automatic Therapy of Atrial Arrhythmias in Patients With Paroxysmal Supraventricular Tachycardias
The goal of APART is the assessment of the therapeutic and preventive stimulation algorithms of the Medtronic AT500 and following devices in patients with atrial tachyarrhythmias and an indication for cardiac pacing according to…
- Trial name
- NCT00170274
- Testing
- Activation of preventive and therapeutic algorithms for treatment of AF, AF Prevention and Therapy Algorithms On
- Where
- 6 sites in Germany
- Volunteers
- 156 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Assess the Benefits From the AAISafeR/SafeR Algorithm of Symphony 2550 or REPLYTM DR in a Wide Range of Pacemaker Patients.
Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.
- Trial name
- ANSWER (NCT00562107)
- Testing
- Symphony DR 2550 and REPLY DR cardiac pacemakers
- Where
- 37 sites in United States, France and 4 more
- Volunteers
- 650 people
- Sponsor
- LivaNova
Sick Sinus Syndrome
Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation
The purpose of this study is to determine which of 4 lead positions is most effective for pacemaker patients with Sick Sinus Syndrome in order to avoid development of atrial fibrillation.
- Trial name
- NCT00161538
- Testing
- Pacing leads to be implanted according randomization., Selection 9000 prevent AF an Diagnose AF
- Where
- 12 sites in Germany
- Volunteers
- 456 people
- Sponsor
- Medtronic BRC
Atrial Fibrillation, Bradycardia
Study for Atrial Fibrillation Reduction (SAFARI)
Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat.
- Trial name
- NCT00267137
- Testing
- Pacing Algorithms
- Where
- 34 sites in United States
- Volunteers
- 540 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Indication for Cardiac Resynchronization Therapy (CRT)
Evia/Entovis HF-T Master Study
The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers.
- Trial name
- NCT01545739
- Testing
- Evia/Entovis HF-T pacemaker for CRT therapy
- Where
- Hungary
- Volunteers
- 122 people
- Sponsor
- Biotronik SE & Co. KG
Heart Disease, Cardiovascular Disease
Remote Interrogation in Rural Emergency Departments
A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REM RED (NCT02421549)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure
Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure
The purpose of this study is to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optimal pharmacologic therapy and 1)…
- Trial name
- NCT00180258
- Testing
- Cardiac Resynchronization Therapy with & without defibrillator
- Where
- United States
- Volunteers
- 2,200 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Congestive Heart Failure
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing…
- Trial name
- AVAIL (NCT00356057)
- Testing
- Protos DR/CLS and Stratos LV CRT pacemakers
- Where
- 10 sites in United States
- Volunteers
- 153 people
- Sponsor
- Biotronik, Inc.
Arrhythmia, Sinus Node Disease
PANORAMA Observational Study
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy)…
- Conditions
- Arrhythmia, Sinus Node Disease, Heart Failure, Heart Block
- Trial name
- NCT00382525
- Testing
- Cardiac Rhythm Management device
- Where
- 27 sites in Belgium, India and 4 more
- Volunteers
- 8,586 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hypertension, Hypertension, Systolic
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure…
- Conditions
- Hypertension, Hypertension, Systolic, Hypertension, Essential
- Trial name
- BACKBEAT (NCT06059638)
- Testing
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated, Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
- Where
- 131 sites in United States, Australia and 13 more
- Volunteers
- 316 people
- Sponsor
- Orchestra BioMed, Inc
Syncope
ISSUE3: International Study on Syncope of Uncertain Etiology 3
ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.
- Trial name
- NCT00359203
- Testing
- Dual chamber pacemeker
- Where
- Italy
- Volunteers
- 511 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Arrythmia, Bradycardia
Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
Temporary cardiac pacing with active-fixation leads (TPAFL) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation.
- Trial name
- TEMPACE (NCT05351658)
- Testing
- KronoSafe® System
- Where
- 2 sites in Spain
- Volunteers
- 30 people
- Sponsor
- ICU Medical Technologies S.L.
Atrial Fibrillation, Atrial Flutter
Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
- Trial name
- SETAM (NCT01108692)
- Testing
- Telecardiology
- Where
- 57 sites in France
- Volunteers
- 602 people
- Sponsor
- Biotronik France
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