Catheter Ablation of Arrhythmias to Improve CRT Response (ABLATE-CRT)

August 17, 2022 updated by: Kansas City Heart Rhythm Institute
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Catheter Ablation
Catheter ablation procedure of atrial and/or ventricular arrhythmias.
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.
Active Comparator: Medical Therapy
Medical management using antiarrhythmic drugs per standard of care of treating physician.
Drug: Anti-Arrhythmics
Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ejection Fraction (EF)
Time Frame: 90 Days
Change in Ejection Fraction (EF)
90 Days
Bi-ventricular Pacing Improvement
Time Frame: 90 Days
data not analyzed
90 Days
Cardiovascular Mortality
Time Frame: 365Days
data not analyzed
365Days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Institute

Collaborators

Biosense Webster, Inc.

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

January 25, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003861

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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