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

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ClinicalTrials.gov Identifier: NCT04065893
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Köln

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
Systolic Heart Failure Ventricular Premature Complexes Ventricular Tachycardia Cardiac Resynchronization Therapy Reduced Biventricular Pacing Procedure: Catheter ablation of ventricular arrhythmia Drug: Intensified medical therapy

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Criteria

Inclusion Criteria:

  • reduced biventricular pacing <98% due to ventricular arrhythmia

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065893


Contacts
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Contact: Jakob Lüker, MD +4922147832396 jakob.lueker@uk-koeln.de
Contact: Jan-Hendrik van den Bruck, MD +4922147884895 jan-hendrik.van-den-bruck@uk-koeln.de

Sponsors and Collaborators
Universitätsklinikum Köln

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Responsible Party: Universitätsklinikum Köln
ClinicalTrials.gov Identifier: NCT04065893     History of Changes
Other Study ID Numbers: CRT-Bivent.
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Heart Failure, Systolic
Ventricular Premature Complexes
Heart Failure
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes
Cardiac Complexes, Premature