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

NCT04065893 | Completed

• 1 other identifier: CRT-Bivent.
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Systolic Heart Failure; Ventricular Premature Complexes; Ventricular Tachycardia; Cardiac Resynchronization Therapy; Reduced Biventricular Pacing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Catheter ablation of ventricular arrhythmia PROCEDURE

PVC or VT ablation

Catheter ablation group

Intensified medical therapy DRUG

Dosage increase / new onset of Betablocker / medical antiarrhythmic medication according to guideline and clinical practice

Medical treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pts. with systolic heart failure, wide QRS complex and CRT with reduced biventricular pacing due to ventricular arrhythmia (PVC/VT)

You may qualify if:

• reduced biventricular pacing \<98% due to ventricular arrhythmia

You may not qualify if:

• reduced biventricular pacing \<98% due to other cause
• age \<18
• pregnancy

Sponsors & Collaborators

• Universitätsklinikum Köln: lead

Study Sites (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (1)

• van den Bruck JH, Middeldorp M, Sultan A, Scheurlen C, Seuthe K, Wormann J, Filipovic K, Kadhim K, Sanders P, Steven D, Luker J. Impact of ventricular arrhythmia management on suboptimal biventricular pacing in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2023 Mar;66(2):353-361. doi: 10.1007/s10840-022-01259-0. Epub 2022 Jun 14.

  PMID: 35697890 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic; Ventricular Premature Complexes; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Cardiac Complexes, Premature; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 22, 2019
• Study Start: September 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)