ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03035227
Recruitment Status : Terminated (Investigator left Institution.)
First Posted : January 27, 2017
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
University of Kansas Medical Center

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 Type : Interventional  (Clinical Trial)
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 : January 23, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

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.




Primary Outcome Measures :
  1. Change in Ejection Fraction (EF) [ Time Frame: 90 Days ]
  2. Bi-ventricular pacing improvement [ Time Frame: 90 Days ]
  3. Cardiovascular mortality [ Time Frame: 365Days ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 365 Days ]
  2. Hospital admissions for heart failure exacerbation [ Time Frame: 365 Days ]
  3. New York Heart Association (NYHA) class change [ Time Frame: 30 Days ]
  4. Change in 6 minute walk test [ Time Frame: 30 Days ]
  5. Change in Quality of Life - SF-36 [ Time Frame: 30 Days ]
  6. Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 30 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035227


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Biosense Webster, Inc.
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03035227     History of Changes
Other Study ID Numbers: STUDY00003861
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents