Clinical trials: Pacemaker Therapy
Right Ventricular Failure, Chronic Thromboembolic Pulmonary Hypertension
Right Ventricular Resynchronization Therapy
The purpose of this study is to determine whether cardiac resynchronization therapy with the use of an implanted electronic pacemaker reduces morbidity associated with chronic thromboembolic pulmonary hypertension
- Conditions
- Right Ventricular Failure, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension
- Trial name
- RVRT (NCT01163422)
- Testing
- Implantation of 3-chamber pacemaker
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Anxiety, Pain
Impact of Virtual Reality on Anxiety and Pain During Implantation of Cardiac Implantable Electronic Devices (CIED)
Purpose: This study aimed to evaluate whether virtual reality technology positively affects patients' pain and anxiety throughout the entire procedure of implantation of cardiac pacemakers, defibrillators, or cardiac…
- Trial name
- CIED (NCT07250282)
- Testing
- Virtual reality headset
- Where
- Germany
- Volunteers
- 111 people
- Sponsor
- Muhammed Kurt
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
Heart Failure, Cardiac Resynchronisation Pacemakers
Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
An evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers.
- Trial name
- CHOICE2 (NCT01055210)
- Testing
- Optimisation of VV delay
- Where
- United Kingdom
- Volunteers
- 31 people
- Sponsor
- University of Dundee
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.
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
Rehabilitation
Effects of Different Physical Therapy Programs on Pulmonary Rehabilitation in Patients With Lung Cancer
This study applies external diaphragm pacemaker and positive expiratory pressure therapy to patients who received thoracic surgeries, in order to explore the effects of different physical therapy programs on pulmonary…
- Trial name
- NCT04914624
- Testing
- ACBT training, acpella®PEP, EDP-type II external diaphragm pacemaker
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Sun Yat-sen University
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
Atrial Fibrillation, Left Atrial Dilatation
His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation
Objective To investigate if conduction system pacing ((CSP) i.e. atrioventricular node ablation + His bundle pacing or Left Bundle Branch pacing) is as good as (or better than) atrial fibrillation ablation with pulmonary vein…
- Trial name
- His-PAAF (NCT04512586)
- Testing
- Conduction System pacing and AV node ablation, Atrial fibrillation ablation by pulmonary vein isolation
- Where
- 4 sites in Sweden
- Volunteers
- 45 people
- Sponsor
- Region Skane
Pacemaker Ddd, ICD
Evaluation of CIED "Readers" for Disease Management
The purpose of this study is to evaluate the use of remote interrogation (readers) of CIEDs in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope.
- Trial name
- NCT03338946
- Testing
- CIED interrogation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Edward Hospital
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
Hemorrhage, Thrombosis
Anticoagulant Therapy During Pacemaker Implantation
There are no established guidelines regarding interruption of warfarin anticoagulant therapy prior to surgical implantation of cardiac pacemakers.
- Conditions
- Hemorrhage, Thrombosis, Embolism
- Trial name
- FINPAC (NCT00479362)
- Testing
- Warfarin, Aspirin, Permanent pacemaker
- Where
- Finland
- Volunteers
- 447 people
- Sponsor
- University of Turku
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
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Reflex Syncope
Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
Reflex syncope is the most common form of syncope. It can lead to injuries and affect quality of life. Nonpharmacological and medical therapies have limited effectiveness.
- Trial name
- PANACEA (NCT05855603)
- Testing
- Cardioneuroablation, Permanent pacemaker therapy
- Where
- 10 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
Postoperative Care After Cardiac Implantable Electronic Device Implantation
Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement
This randomized controlled trial will evaluate the effects of short-term medical arm sling use during the first 24 hours after cardiac implantable electronic device (CIED) implantation on patient comfort, pain, satisfaction, and…
- Trial name
- CIED-SLING24 (NCT07810426)
- Testing
- Medical Arm Sling
- Volunteers
- 104 people
- Sponsor
- Tugba Yorulmaz
Sick Sinus Syndrome
RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome
Background: Potential negative effects of pacing in the RV-apex are well documented However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial.
- Trial name
- VOTE (NCT01477138)
- Testing
- pacemaker implantation, AAI(R)-DDD(R) versus DDD(R)
- Where
- Germany
- Volunteers
- 126 people
- Sponsor
- Klinikum Nürnberg
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