Catheter Ablation of Arrhythmias to Improve CRT Response

Phase 4

Terminated

• Conditions: Arrhythmia, Cardiac
• Interventions: Procedure: Catheter Ablation; Drug: Anti-Arrhythmics

• Registration Number: NCT03035227
• Lead Sponsor: Kansas City Heart Rhythm Institute

Brief Summary

The purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-23
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Status Verified: 2020-04
• Results First Submitted: 2020-04-16
• Results First Submitted QC: 2022-08-17
• Last Update Submitted: 2022-08-17
• Results First Posted: 2022-09-10
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Heart failure patients with CRT-D or CRT-P greater than 3 months
• Bi-ventricular pacing less than 94% of the time
• 3 months after CRT-D or CRT-P implantation an EF improvement less than 5%
• Presence of one of the following arrhythmias and eligible for catheter ablation:
• Atrial fibrillation
• Atrial flutter
• Supraventricular tachycardia
• Premature ventricular contraction burden greater than 30% in a 24-hour period
• Ventricular tachycardia

Exclusion Criteria

• Estimated survival less than one year
• Patient unable to make scheduled follow up visits at treating center
• Participating in another investigational study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter Ablation	Catheter Ablation	Catheter ablation procedure of atrial and/or ventricular arrhythmias.
Medical Therapy	Anti-Arrhythmics	Medical management using antiarrhythmic drugs per standard of care of treating physician.

Primary Outcome Measures

Name	Time	Method
Change in Ejection Fraction (EF)	90 Days	Change in Ejection Fraction (EF)
Bi-ventricular Pacing Improvement	90 Days	data not analyzed
Cardiovascular Mortality	365Days	data not analyzed

Secondary Outcome Measures

Name	Time	Method
All-cause Mortality	365 Days	data was not analyzed
Hospital Admissions for Heart Failure Exacerbation	365 Days	data not analyzed
New York Heart Association (NYHA) Class Change	30 Days
Change in 6 Minute Walk Test	30 Days	data not analyzed
Change in Quality of Life - SF-36	30 Days	data not analyzed
Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)	30 Days	data not analyzed

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States