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NCT04065893 Clinical Trial

Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy

Ventricular Tachycardia Clinical Trial

Official title:
Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04065893
Other study ID # CRT-Bivent.
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date August 1, 2021

Study information
Verified date November 2021
Source Universitätsklinikum Köln
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date August 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - reduced biventricular pacing <98% due to ventricular arrhythmia Exclusion Criteria: - reduced biventricular pacing <98% due to other cause - age <18 - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Catheter ablation of ventricular arrhythmia
PVC or VT ablation
Drug:
• Intensified medical therapy
Dosage increase / new onset of Betablocker / medical antiarrhythmic medication according to guideline and clinical practice

Locations
Country Name City State
Germany University Hospital Cologne Cologne NRW

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Biventricular pacing 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
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