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

• Sponsor: Universitätsklinikum Köln (Other)
• Overall Status: Completed
• CT.gov ID: NCT04065893
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Actual Duration (Months): 11
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Systolic Heart Failure; Ventricular Premature Complexes; Ventricular Tachycardia; Cardiac Resynchronization Therapy; Reduced Biventricular Pacing	Procedure: Catheter ablation of ventricular arrhythmia; Drug: Intensified medical therapy

Study Design

• Study Type: Observational
• Actual Enrollment: 65 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Aug 1, 2021
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Biventricular pacing [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• reduced biventricular pacing <98% due to ventricular arrhythmia

Exclusion Criteria:

• reduced biventricular pacing <98% due to other cause

• age <18

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Cologne	Cologne	NRW	Germany	50937

Sponsors and Collaborators

• Universitätsklinikum Köln

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitätsklinikum Köln
• ClinicalTrials.gov Identifier: NCT04065893
• Other Study ID Numbers: CRT-Bivent.
• First Posted: Aug 22, 2019
• Last Update Posted: Nov 15, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular; Heart Failure, Systolic; Ventricular Premature Complexes

Study Results

No Results Posted as of Nov 15, 2021