Heart FailurePhase 4NCT00729911
Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
A Phase 4 study testing Atrial Fibrillation ablation and Amiodarone in people with Heart Failure, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
Trial summary
1. 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. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Atrial Fibrillation ablation and Amiodarone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78758
About this study
Official title: Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD
- 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.
- Conditions
- Heart Failure
- Being tested
- Atrial Fibrillation ablation, Amiodarone
- Keywords
- Atrial fibrillation Ablation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial Fibrillation ablationProcedure or surgery
Radio-frequency catheter ablation of atrial fibrillation
AmiodaroneDrug
Taken orally on a daily basis.
| Study group | Role | What they receive |
|---|---|---|
| AF ablation | Active comparator | 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. Receives: Procedure: Atrial Fibrillation ablation |
| Amiodarone | Active comparator | Amiodarone is taken orally on a daily basis. Receives: Drug: Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recurrence of AF lasting longer than 15 seconds
Measured: 1 year
Secondary outcomes (4)
Change in distance walked in 6-minute walk test
Measured: 1 year
Total number of hospitalizations during the trial period for each group
Measured: 1 year
Change in MLHF Quality of Life during trial period
Measured: 1 year
Change in EF during trial period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Casa Sollievo della Sofferenza IRCCS, Catholic University, Italy, Southlake Health, Stanford University, University of Kansas, The University of Texas Medical Branch, Galveston, University of Foggia, Sutter Health
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Andrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Research FoundationLuigi Di Biase, MD, PhD, Principal investigator, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729911
- Sponsor's protocol ID
- AATAC-AF
- Status last verified
- Apr 2019
- First submitted
- 6 Aug 2008
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27029350
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD
- ClinicalTrials.gov ID
- NCT00729911
- Acronym / sponsor ID
- AATAC-AF
- Conditions
- Heart Failure
- Keywords
- Atrial fibrillation Ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Collaborators
- Casa Sollievo della Sofferenza IRCCS, Catholic University, Italy, Southlake Health, Stanford University, University of Kansas, The University of Texas Medical Branch, Galveston, University of Foggia, Sutter Health
- Study start
- Oct 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF ablation | Active comparator | Procedure: Atrial Fibrillation ablationSubjects 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 | Active comparator | Drug: AmiodaroneAmiodarone is taken orally on a daily basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial Fibrillation ablationRadio-frequency catheter ablation of atrial fibrillation | Procedure or surgery | AF ablation |
| AmiodaroneTaken orally on a daily basis. | Drug | Amiodarone |
Primary outcome
Time to Recurrence of AF lasting longer than 15 seconds
Time frame: 1 year
4 secondary outcomes
Change in distance walked in 6-minute walk test
Time frame: 1 year
Total number of hospitalizations during the trial period for each group
Time frame: 1 year
Change in MLHF Quality of Life during trial period
Time frame: 1 year
Change in EF during trial period
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Derived from this study: PubMed 27029350Di 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natale, MD principal investigator
Texas Cardiac Arrhythmia Research Foundation
Luigi Di Biase, MD, PhD principal investigator
Texas Cardiac Arrhythmia Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atrial Fibrillation ablation and Amiodarone in people with Heart Failure, run by Texas Cardiac Arrhythmia Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Recurrence of AF lasting longer than 15 seconds (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00729911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.