ABLATE-CRT: Catheter Ablation of Arrhythmias to Improve CRT Response

• Sponsor: Kansas City Heart Rhythm Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03035227
• Collaborator: Biosense Webster, Inc. (Industry)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.2
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia, Cardiac	Procedure: Catheter Ablation; Drug: Anti-Arrhythmics	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Catheter Ablation of Arrhythmias to Improve CRT Response
• Actual Study Start Date: Jan 23, 2017
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Ejection Fraction (EF) [90 Days]

2. Bi-ventricular pacing improvement [90 Days]

3. Cardiovascular mortality [365Days]

Secondary Outcome Measures

1. All-cause mortality [365 Days]

2. Hospital admissions for heart failure exacerbation [365 Days]

3. New York Heart Association (NYHA) class change [30 Days]

4. Change in 6 minute walk test [30 Days]

5. Change in Quality of Life - SF-36 [30 Days]

6. Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ) [30 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• Kansas City Heart Rhythm Institute
• Biosense Webster, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kansas City Heart Rhythm Institute
• ClinicalTrials.gov Identifier: NCT03035227
• Other Study ID Numbers: STUDY00003861
• First Posted: Jan 27, 2017
• Last Update Posted: Sep 30, 2019
• Last Verified: Sep 1, 2019

• 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
• Additional relevant MeSH terms: Arrhythmias, Cardiac; Anti-Arrhythmia Agents

Study Results

No Results Posted as of Sep 30, 2019