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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

Tracking Information
First Submitted Date August 16, 2019
First Posted Date August 22, 2019
Last Update Posted Date September 5, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 3, 2019)
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.
Original Primary Outcome Measures
 (submitted: August 21, 2019)
Impact on 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.
Change History Complete list of historical versions of study NCT04065893 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Official Title Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition
  • Systolic Heart Failure
  • Ventricular Premature Complexes
  • Ventricular Tachycardia
  • Cardiac Resynchronization Therapy
  • Reduced Biventricular Pacing
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
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Drug: Intensified medical therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 21, 2019)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • reduced biventricular pacing <98% due to ventricular arrhythmia

Exclusion Criteria:

  • reduced biventricular pacing <98% due to other cause
  • age <18
  • pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
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
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04065893
Other Study ID Numbers CRT-Bivent.
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Universitätsklinikum Köln
Study Sponsor Universitätsklinikum Köln
Collaborators Not Provided
Investigators Not Provided
PRS Account Universitätsklinikum Köln
Verification Date September 2019