Catheter Ablation of Arrhythmias to Improve CRT Response

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-23

Study Completion Date

2018-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Arrhythmia, Cardiac

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Catheter Ablation

Catheter ablation procedure of atrial and/or ventricular arrhythmias.

Group Type ACTIVE_COMPARATOR

Catheter Ablation

Intervention Type PROCEDURE

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

Medical Therapy

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

Group Type ACTIVE_COMPARATOR

Anti-Arrhythmics

Intervention Type DRUG

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

Interventions

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Catheter Ablation

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

Intervention Type PROCEDURE

Anti-Arrhythmics

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No