- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065893
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. Most effective mortality reduction was seen with a BiV pacing above 98%.
Reduced BiV pacing is a common phenomenon with potential impact on CRT-response and pts' prognosis. Frequent ventricular ectopy may be associated with attenuated benefit from CRT. The investigators sought to systematically assess the effect of ventricular arrhythmia treatment on BiV pacing.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
NRW
-
Cologne, NRW, Germany, 50937
- University Hospital Cologne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- reduced biventricular pacing <98% due to ventricular arrhythmia
Exclusion Criteria:
- reduced biventricular pacing <98% due to other cause
- age <18
- pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Catheter ablation group
Patients with reduced biventricular pacing due to PVC or VT receiving catheter ablation of PVC/VT according to guidelines and clinical practices
|
PVC or VT ablation
|
Medical treatment group
Patients with reduced biventricular pacing due to PVC or VT receiving intensified medical therapy (antiarrhythmics/betablocker) according to guidelines and clinical practices
|
Dosage increase / new onset of Betablocker / medical antiarrhythmic medication according to guideline and clinical practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Biventricular pacing
Time Frame: 3 month after intervention biventricular pacing (%) is routinely monitored
|
Influence of intervention (Ablation/medical treatment) on previously reduced biventricular pacing percentage (<98%).
Biventricular pacing is measured in percentage of stimulation and is monitored at routine device interrogation.
|
3 month after intervention biventricular pacing (%) is routinely monitored
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRT-Bivent.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventricular Tachycardia
-
University of PretoriaCompletedSupra-ventricular TachycardiaSouth Africa
-
Ottawa Heart Institute Research CorporationNot yet recruitingVentricular Fibrillation | Ventricular Tachycardia | Ventricular Arrhythmias | Recurrent Ventricular Tachycardia
-
Armgo Pharma, Inc.Food and Drug Administration (FDA)RecruitingCatecholaminergic Polymorphic Ventricular Tachycardia Type 1United States, Netherlands
-
University of Turin, ItalyAzienda Unità Sanitaria Locale Reggio Emilia; IRCCS Sacro Cuore Don Calabria... and other collaboratorsRecruitingRefractory Ventricular TachycardiaItaly
-
Thermedical, Inc.Not yet recruitingRefractory Ventricular TachycardiaUnited States, Canada
-
John SappCompleted
-
University of California, Los AngelesCompletedRefractory Ventricular TachycardiaUnited States
-
Hospital General Universitario Gregorio MarañonCompletedMonomorphic Ventricular TachycardiaSpain
-
Abbott Medical DevicesTerminatedMonomorphic Ventricular TachycardiaUnited States, United Kingdom, France, Australia, Italy
-
Abbott Medical DevicesWithdrawn
Clinical Trials on Catheter ablation of ventricular arrhythmia
-
Field MedicalNot yet recruitingVentricular Tachycardia | Ventricular Arrythmia | Ventricular Tachyarrhythmia | PVC - Premature Ventricular Complex | PVC - Premature Ventricular ContractionCzechia
-
University Medical Centre LjubljanaCompletedVentricular Tachycardia | Ischemic CardiomyopathySlovenia, Croatia
-
Royal Brompton & Harefield NHS Foundation TrustCompletedHeart Failure | Atrial FibrillationUnited Kingdom
-
Universitätsklinikum Hamburg-EppendorfMedtronicTerminatedVentricular Tachycardia | CardiomyopathyGermany
-
IRCCS San RaffaeleUnknownVentricular TachycardiasBelgium, Czechia, France, Germany, Italy, Portugal, Switzerland
-
University of California, San DiegoCatheter Robotics, Inc.CompletedAtrial Fibrillation | Atrial FlutterUnited States
-
Rush University Medical CenterMedical University of South Carolina; University of Michigan; The Cleveland Clinic and other collaboratorsNot yet recruitingVentricular Tachycardia | Ischemic CardiomyopathyUnited States
-
Central Hospital, Nancy, FranceRecruitingVentricular Tachycardia | Ischemic CardiomyopathyFrance
-
University Hospital, ToulouseUnknownVentricular TachycardiaFrance
-
Yuksek Ihtisas HospitalUnknownVentricular Tachycardia | Ischemic Cardiomyopathy | ICD ShockTurkey