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Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD

Primary Purpose

Heart Failure

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Atrial Fibrillation ablation

Amiodarone

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Atrial fibrillation Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with an dual chamber ICD or CRTD (with an existing functional atrial lead) with remote monitoring capabilities and EF <= 40% within the last 3 months by echocardiogram, nuclear imaging, MRI or cardiac catheterization,
Persistent or chronic symptomatic AF resistant to anti-arrhythmic medication other than Amiodarone. Resistant defined as recurrent AF of greater than 5 minutes duration at least once per month.
Therapeutic anticoagulation for at least three weeks prior to initiation of therapy
Ability to complete 6 minute walk test.
Age >= 18 years old. (Females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control [defined as injectable or implantable hormonal contraceptives, oral contraceptives, intrauterine device, diaphragm plus spermicide], or have had a hysterectomy, bilateral oophorectomy, or tubal ligation performed at least 6 months prior to enrollment).
All patients optimized on CHF medications including beta-blocker and ace-inhibitor or angiotensin-receptor blocker.
patients receiving low dose amiodarone- <200 mg for 2 or less months

Exclusion Criteria:

The exclusion criteria are:

Reversible causes of AF such as pericarditis, hyperthyroidism,
Presently with Valvular Heart disease requiring surgical intervention
Presently with coronary artery disease requiring surgical intervention
Early Post-operative AF (within three months of surgery)
Previous MAZE or left atrial instrumentation
Prolonged QT interval
Hypothyroidism
Liver Failure
Life expectancy <= 2 years
Social factors that would preclude follow up or make compliance difficult.
Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin
Enrollment in another investigational drug or device study.
Patients with severe pulmonary disease i.e. COPD or asthma
Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction
Any ophthalmologic disorders (other than requiring glasses for vision correction)

Sites / Locations

Texas Cardiac Arrhythmia Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

AF ablation

Amiodarone

Arm Description

Subjects assigned to the catheter ablation strategy will undergo catheter based AF ablation. The goal of the procedure is to achieve isolation of all 4 pulmonary veins. Subjects assigned to receive Amiodarone will have the oral medication initiated in an clinic setting.

Amiodarone is taken orally on a daily basis.

Outcomes

Primary Outcome Measures

Time to Recurrence of AF lasting longer than 15 seconds

Secondary Outcome Measures

Change in distance walked in 6-minute walk test

Total number of hospitalizations during the trial period for each group

Change in MLHF Quality of Life during trial period

Change in EF during trial period

Full Information

NCT ID

NCT00729911

First Posted

August 6, 2008

Last Updated

April 8, 2019

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Collaborators

Casa Sollievo della Sofferenza IRCCS, Catholic University, Italy, Southlake Regional Health Centre, Stanford University, University of Kansas, The University of Texas Medical Branch, Galveston, University of Foggia, Sutter Health

1. Study Identification

Unique Protocol Identification Number

NCT00729911

Brief Title

Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD

Official Title

Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas Cardiac Arrhythmia Research Foundation

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To determine if catheter-based atrial fibrillation (AF) ablation is superior to Amiodarone treatment for symptomatic persistent/permanent AF in ICD/CRTD patients with an impaired left ventricular function. Hypothesis: AF ablation is better than Amiodarone for subjects with symptomatic persistent or permanent AF and impaired LV function in terms of recurrence of AF, quality of life, 6-minute walk distance, EF and total number of hospitalizations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Atrial fibrillation Ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AF ablation

Arm Type

Active Comparator

Arm Description

Arm Title

Amiodarone

Arm Type

Active Comparator

Arm Description

Amiodarone is taken orally on a daily basis.

Intervention Type

Procedure

Intervention Name(s)

Atrial Fibrillation ablation

Intervention Description

Radio-frequency catheter ablation of atrial fibrillation

Intervention Type

Drug

Intervention Name(s)

Amiodarone

Intervention Description

Taken orally on a daily basis.

Primary Outcome Measure Information:

Title

Time to Recurrence of AF lasting longer than 15 seconds

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Change in distance walked in 6-minute walk test

Time Frame

1 year

Title

Total number of hospitalizations during the trial period for each group

Time Frame

1 year

Title

Change in MLHF Quality of Life during trial period

Time Frame

1 year

Title

Change in EF during trial period

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with an dual chamber ICD or CRTD (with an existing functional atrial lead) with remote monitoring capabilities and EF <= 40% within the last 3 months by echocardiogram, nuclear imaging, MRI or cardiac catheterization, Persistent or chronic symptomatic AF resistant to anti-arrhythmic medication other than Amiodarone. Resistant defined as recurrent AF of greater than 5 minutes duration at least once per month. Therapeutic anticoagulation for at least three weeks prior to initiation of therapy Ability to complete 6 minute walk test. Age >= 18 years old. (Females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control [defined as injectable or implantable hormonal contraceptives, oral contraceptives, intrauterine device, diaphragm plus spermicide], or have had a hysterectomy, bilateral oophorectomy, or tubal ligation performed at least 6 months prior to enrollment). All patients optimized on CHF medications including beta-blocker and ace-inhibitor or angiotensin-receptor blocker. patients receiving low dose amiodarone- <200 mg for 2 or less months Exclusion Criteria: The exclusion criteria are: Reversible causes of AF such as pericarditis, hyperthyroidism, Presently with Valvular Heart disease requiring surgical intervention Presently with coronary artery disease requiring surgical intervention Early Post-operative AF (within three months of surgery) Previous MAZE or left atrial instrumentation Prolonged QT interval Hypothyroidism Liver Failure Life expectancy <= 2 years Social factors that would preclude follow up or make compliance difficult. Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin Enrollment in another investigational drug or device study. Patients with severe pulmonary disease i.e. COPD or asthma Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction Any ophthalmologic disorders (other than requiring glasses for vision correction)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Natale, MD

Organizational Affiliation

Texas Cardiac Arrhythmia Research Foundation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luigi Di Biase, MD, PhD

Organizational Affiliation

Texas Cardiac Arrhythmia Research Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Cardiac Arrhythmia Research Foundation

City

Austin

State/Province

Texas

ZIP/Postal Code

78758

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27029350

Citation

Di Biase L, Mohanty P, Mohanty S, Santangeli P, Trivedi C, Lakkireddy D, Reddy M, Jais P, Themistoclakis S, Dello Russo A, Casella M, Pelargonio G, Narducci ML, Schweikert R, Neuzil P, Sanchez J, Horton R, Beheiry S, Hongo R, Hao S, Rossillo A, Forleo G, Tondo C, Burkhardt JD, Haissaguerre M, Natale A. Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device: Results From the AATAC Multicenter Randomized Trial. Circulation. 2016 Apr 26;133(17):1637-44. doi: 10.1161/CIRCULATIONAHA.115.019406. Epub 2016 Mar 30.

Results Reference

derived

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Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD

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