Catheter Ablation of Arrhythmias to Improve CRT Response

Arrhythmia, Cardiac Clinical Trial

— ABLATE-CRT  

Official title:

Catheter Ablation of Arrhythmias to Improve CRT Response

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03035227
• Other study ID #: STUDY00003861
• Status: Terminated
• Phase: Phase 4
• Start date: January 23, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: April 2020
• Source: Kansas City Heart Rhythm Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia, Cardiac
• Arrhythmias, Cardiac

Intervention

Procedure:
• Catheter Ablation
Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists.

Drug:
• Anti-Arrhythmics
Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Institute	Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ejection Fraction (EF)	Change in Ejection Fraction (EF)	90 Days
Primary	Bi-ventricular Pacing Improvement	data not analyzed	90 Days
Primary	Cardiovascular Mortality	data not analyzed	365Days
Secondary	All-cause Mortality	data was not analyzed	365 Days
Secondary	Hospital Admissions for Heart Failure Exacerbation	data not analyzed	365 Days
Secondary	New York Heart Association (NYHA) Class Change		30 Days
Secondary	Change in 6 Minute Walk Test	data not analyzed	30 Days
Secondary	Change in Quality of Life - SF-36	data not analyzed	30 Days
Secondary	Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)	data not analyzed	30 Days