Back to resultsCatheter Ablation of Arrhythmias to Improve CRT Response (ABLATE-CRT)
Primary Purpose
Arrhythmia, Cardiac
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Catheter Ablation
Anti-Arrhythmics
Sponsored by
About this trial
This is an interventional prevention trial for Arrhythmia, Cardiac
Eligibility Criteria
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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Catheter Ablation
Medical Therapy
Arm Description
Catheter ablation procedure of atrial and/or ventricular arrhythmias.
Medical management using antiarrhythmic drugs per standard of care of treating physician.
Outcomes
Primary Outcome Measures
Change in Ejection Fraction (EF)
Change in Ejection Fraction (EF)
Bi-ventricular Pacing Improvement
data not analyzed
Cardiovascular Mortality
data not analyzed
Secondary Outcome Measures
All-cause Mortality
data was not analyzed
Hospital Admissions for Heart Failure Exacerbation
data not analyzed
New York Heart Association (NYHA) Class Change
Change in 6 Minute Walk Test
data not analyzed
Change in Quality of Life - SF-36
data not analyzed
Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)
data not analyzed
Full Information
NCT ID
NCT03035227
First Posted
January 25, 2017
Last Updated
August 17, 2022
Sponsor
Kansas City Heart Rhythm Institute
Collaborators
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03035227
Brief Title
Catheter Ablation of Arrhythmias to Improve CRT Response
Acronym
ABLATE-CRT
Official Title
Catheter Ablation of Arrhythmias to Improve CRT Response
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Investigator left Institution.
Study Start Date
January 23, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kansas City Heart Rhythm Institute
Collaborators
Biosense Webster, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, Cardiac
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Catheter Ablation
Arm Type
Active Comparator
Arm Description
Catheter ablation procedure of atrial and/or ventricular arrhythmias.
Arm Title
Medical Therapy
Arm Type
Active Comparator
Arm Description
Medical management using antiarrhythmic drugs per standard of care of treating physician.
Intervention Type
Procedure
Intervention Name(s)
Catheter Ablation
Intervention Description
Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists.
Intervention Type
Drug
Intervention Name(s)
Anti-Arrhythmics
Intervention Description
Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.
Primary Outcome Measure Information:
Title
Change in Ejection Fraction (EF)
Description
Change in Ejection Fraction (EF)
Time Frame
90 Days
Title
Bi-ventricular Pacing Improvement
Description
data not analyzed
Time Frame
90 Days
Title
Cardiovascular Mortality
Description
data not analyzed
Time Frame
365Days
Secondary Outcome Measure Information:
Title
All-cause Mortality
Description
data was not analyzed
Time Frame
365 Days
Title
Hospital Admissions for Heart Failure Exacerbation
Description
data not analyzed
Time Frame
365 Days
Title
New York Heart Association (NYHA) Class Change
Time Frame
30 Days
Title
Change in 6 Minute Walk Test
Description
data not analyzed
Time Frame
30 Days
Title
Change in Quality of Life - SF-36
Description
data not analyzed
Time Frame
30 Days
Title
Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
data not analyzed
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD
Organizational Affiliation
Kansas City Heart Rhythm Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Catheter Ablation of Arrhythmias to Improve CRT Response
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