NCT03035227

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

September 10, 2022

Completed
Last Updated

September 10, 2022

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

January 25, 2017

Results QC Date

April 16, 2020

Last Update Submit

August 17, 2022

Conditions

Arrhythmia, Cardiac

Outcome Measures

Primary Outcomes (3)

  • Change in Ejection Fraction (EF)

    Change in Ejection Fraction (EF)

    90 Days

  • Bi-ventricular Pacing Improvement

    data not analyzed

    90 Days

  • Cardiovascular Mortality

    data not analyzed

    365Days

Secondary Outcomes (6)

  • All-cause Mortality

    365 Days

  • Hospital Admissions for Heart Failure Exacerbation

    365 Days

  • New York Heart Association (NYHA) Class Change

    30 Days

  • Change in 6 Minute Walk Test

    30 Days

  • Change in Quality of Life - SF-36

    30 Days

  • +1 more secondary outcomes

Study Arms (2)

Catheter Ablation

ACTIVE COMPARATOR

Catheter ablation procedure of atrial and/or ventricular arrhythmias.

Procedure: Catheter Ablation

Medical Therapy

ACTIVE COMPARATOR

Medical management using antiarrhythmic drugs per standard of care of treating physician.

Drug: Anti-Arrhythmics

Interventions

Catheter AblationPROCEDURE

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

Catheter Ablation
Anti-ArrhythmicsDRUG

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

Medical Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure patients with CRT-D or CRT-P greater than 3 months
  • Bi-ventricular pacing less than 94% of the time
  • 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

You may not qualify if:

  • Estimated survival less than one year
  • Patient unable to make scheduled follow up visits at treating center
  • Participating in another investigational study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Catheter AblationAnti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Dr. Dhanunjaya Lakkireddy
Organization
Kansas City Heart Rhythm Institute
dhanunjaya.lakkireddy@hcahealthcare.com
913-449-1297

Study Officials

  • Dhanunjaya Lakkireddy, MD

    Kansas City Heart Rhythm Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 27, 2017

Study Start

January 23, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 10, 2022

Results First Posted

September 10, 2022

Record last verified: 2020-04

Locations

US(1)