Clinical trials: Resynchronization Therapy
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Atrial Fibrillation
Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System
The purpose of the BIO-AffectDX Study is to prospectively evaluate improvement from baseline in heart failure subjects with atrial fibrillation (AF) implanted with a two-lead CRT-DX system, with emphasis on a comparison of…
- Conditions
- Heart Failure, Atrial Fibrillation, Cardiac Resynchronization Therapy
- Trial name
- BIO-AffectDX (NCT04870281)
- Testing
- CRT-DX
- Where
- 23 sites in United States
- Volunteers
- 13 people
- Sponsor
- Biotronik, Inc.
Heart Failure, Cardiac Pacing, Artificial
Acute Effects of LBBP Versus BVP for CRT
The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) <=35% with left bundle branch block (LBBB).
- Conditions
- Heart Failure, Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy
- Trial name
- NCT04505384
- Testing
- left bundle branch pacing, biventricular pacing
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Shanghai Zhongshan Hospital
Systolic Heart Failure, Ventricular Premature Complexes
Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure.
- Conditions
- Systolic Heart Failure, Ventricular Premature Complexes, Ventricular Tachycardia, Cardiac Resynchronization Therapy
- Trial name
- NCT04065893
- Testing
- Catheter ablation of ventricular arrhythmia, Intensified medical therapy
- Where
- Germany
- Volunteers
- 65 people
- Sponsor
- Universitätsklinikum Köln
Heart Failure, Cardiac Resynchronization Therapy
Narrow QRS HF Patients Assessed by ECG Belt
The purpose of this study is to quantitate electrical dyssynchrony in heart failure (HF) patients with a narrow QRS complexes (≤ 130 ms) using the ECG Belt.
- Trial name
- NCT03367104
- Testing
- ECG Belt
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Allina Health System
Heart Failure, Cardiac Resynchronization Therapy
Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality.
- Trial name
- OPTIREG (NCT03789487)
- Testing
- Device programming of CRT pacemaker or defibrillator
- Where
- 3 sites in France
- Volunteers
- 27 people
- Sponsor
- CMC Ambroise Paré
Cardiac Resynchronization Therapy
Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads
The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety, performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT™ ventricular defibrillation…
- Trial name
- NAVIGATE X4 (NCT02071173)
- Testing
- ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead
- Where
- 96 sites in United States
- Volunteers
- 2,244 people
- Sponsor
- Boston Scientific Corporation
Systolic Heart Failure, Cardiac Resynchronization Therapy
ECG for Programming in CRT
Patients with heart failure and left bundle branch block benefit from Cardiac Resynchronization Therapy (CRT) that delivers pacing from right ventricle (RV) and left ventricle (LV) synchronously, resulting in electrical…
- Conditions
- Systolic Heart Failure, Cardiac Resynchronization Therapy, Electrocardiography
- Trial name
- EPIC (NCT03936608)
- Testing
- Programming individualized RV-LV pacing offset to optimize ECG, Nominally programming CRT device without RV-LV offset
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Washington University School of Medicine
Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy
Electrical Resynchronization and Acute Hemodynamic Effects of Direct His Bundle Pacing Compared to Biventricular Pacing
The aims are to compare Direct His Bundle Pacing (DHBP) with biventricular pacing (BiV) in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using…
- Conditions
- Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy, Direct His Bundle Pacing
- Trial name
- NCT03452462
- Testing
- Pacing
- Where
- Switzerland
- Volunteers
- 19 people
- Sponsor
- University Hospital, Geneva
Cardiac Resynchronization Therapy
Acute Evaluation of the Safety of Left Ventricular-left Ventricular (LV-LV) Delays and Its Effects on Mechanical Dyssynchrony
The purpose of this study is to evaluate the effects of various LV-LV delays during multi-site left ventricular (MSLV) pacing on mechanical dyssynchrony in cardiac resynchronization therapy (CRT) patients post-implant.
- Trial name
- NCT01044784
- Where
- Germany
- Volunteers
- 73 people
- Sponsor
- Abbott Medical Devices
Hematoma Postoperative, Cardiac Resynchronization Therapy Devices
Prevention of Pocket Hematoma After Implantation Cardiovascular Implanted Electronic Devices
As the number of implanted cardiovascular implanted electronic devices (CIEDs) increases, the incidence of their complications also grows.
- Conditions
- Hematoma Postoperative, Cardiac Resynchronization Therapy Devices, Compression Bandages
- Trial name
- NCT04389398
- Testing
- pocket compression fixation belt
- Volunteers
- 80 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Pacemaker Therapy, Cardiac Resynchronization Therapy
BIO|MASTER.Edora Family Study
This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions.
- Trial name
- NCT03091322
- Testing
- Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
- Where
- 11 sites in Austria, Germany and 2 more
- Volunteers
- 120 people
- Sponsor
- Biotronik SE & Co. KG
Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy
Multi Point Pacing vs. Conventional STUDY PROTOCOL
The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy
- Trial name
- CRT-MPP (NCT04334018)
- Testing
- conventional CRT, MPP CRT
- Where
- 6 sites in France, Monaco
- Sponsor
- CMC Ambroise Paré
Cardiac Resynchronization Therapy
Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay
Observational, retrospective and perspective study with acute and chronic endpoints
- Trial name
- IMAGE-CRT (NCT02713308)
- Where
- 2 sites in Italy
- Volunteers
- 248 people
- Sponsor
- Monaldi Hospital
Cardiac Resynchronization Therapy
Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment
Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment
- Trial name
- COMPACT-MPP (NCT04299360)
- Testing
- Cardiac Resynchronization Therapy device programming
- Where
- 3 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Heart Failure, Left Ventricular Dysfunction
Use of 3-D Blood Pool Scintigraphy to Guide Left Ventricular Pacing Lead Placement in Patients Requiring Cardiac Resynchronization Therapy
The purpose of this study is to determine whether multiple gated acquisition (MUGA) guided lead placement improves clinical outcomes for patients needing cardiac resynchronization therapy (CRT) compared to traditional…
- Conditions
- Heart Failure, Left Ventricular Dysfunction, Cardiac Resynchronization Therapy
- Trial name
- MUGA CRT (NCT02669290)
- Testing
- Guided, Non-guided
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Francisco
Cardiac Resynchronization Therapy, Non-LBBB, QRS Area
MARC-2: MARKERS AND RESPONSE TO CRT in Non-LBBB
The purpose of the MARC-2 study is to investigate the relation of the QRS area, determined by vectorcardiography, and response to Cardiac Resynchronization Therapy (CRT) in patients with a wide QRS complex and without a typical…
- Trial name
- MARC-2 (NCT04120909)
- Testing
- Cardiac resynchronization therapy
- Where
- Netherlands
- Volunteers
- 800 people
- Sponsor
- Maastricht University Medical Center
Cardiac Resynchronization Therapy, Chronic Heart Failure
Exercise Training Following Cardiac Resynchronization Therapy in Patients With Chronic Heart Failure
Cardiac resynchronization therapy(CRT) is recommended to reduce mortality and morbidity in chronic heart failure(CHF) patients New York Heart Association(NYHA) class III-IV who are symptomatic despite optimal medical therapy…
- Trial name
- NCT02413151
- Testing
- Exercise training program, Cardiac resynchronization therapy (CRT)
- Where
- Portugal
- Volunteers
- 62 people
- Sponsor
- University of Lisbon
Cardiac Resynchronization Therapy
SonR Based Stimulation-VECtor OPTimisation in CRT Patients
The primary aim of the present study is to investigate whether the optimisation of LVSV in addition to the optimisation of AV-D and VV-D when using the device-based sensor technology mentioned above results in an improved…
- Trial name
- VECTOPT (NCT03092349)
- Testing
- Vector optimisation
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision
St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.
- Trial name
- REACT (NCT01090349)
- Testing
- Implantation of an ICD/CRT-D device, Merlin.NET PCN
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 220 people
- Sponsor
- Abbott Medical Devices