Clinical trial NCT00514735: Tailored Treatment of Permanent Atrial Fibrillation
Official title: Tailored Treatment of Permanent Atrial Fibrillation - TTOP-AF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2007-08-10
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.


Eligibility criteria: INCLUSION CRITERIA:

* History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days.
* Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance
* Age between 18 and 70 years
* Failure of at least one Class I or III rhythm control drug
* Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.

EXCLUSION CRITERIA:

* Structural heart disease of clinical significance including:

  * Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair)
  * Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction \<40% measured by acceptable cardiac testing
  * Left atrial diameter \>55 mm
  * Moderate to severe mitral or aortic valvular heart disease
  * Stable/unstable angina or ongoing myocardial ischemia
  * Myocardial infarction (MI) within 3 months of enrollment
  * Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
  * Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach
  * Hypertrophic cardiomyopathy (left ventricular septal wall thickness \>1.5 cm)
  * Pulmonary hypertension (mean or systolic pulmonary artery pressure \>50 mm Hg on Doppler echo)
* Any prior ablation for atrial fibrillation
* Enrollment in any other ongoing arrhythmia study
* Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
* Active infection or sepsis
* Any history of cerebral vascular disease including stroke or transient ischemic attacks
* Pregnancy or lactation
* Left atrial thrombus at the time of ablation
* Untreatable allergy to contrast media
* Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
* History of blood clotting (bleeding or thrombotic) abnormalities
* Known sensitivities to heparin or warfarin
* Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) \<1)
* Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate

Primary outcomes:
measure: Chronic Effectiveness
timeFrame: 6 months
measure: Acute Safety
timeFrame: 7 days
measure: Chronic Safety
timeFrame: 6 months
Secondary outcomes:
measure: Acute Efficacy
timeFrame: Procedure conclusion
measure: Improvement of Left Atrial Size at 6 Months Compared to Baseline.
timeFrame: 6 months
measure: Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.
timeFrame: 6 months
measure: Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.
timeFrame: 6 months
measure: Improved Quality of Life Over 6 Months Compared to Baseline.
timeFrame: 6 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Cardiac Arrhythmia Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Emory Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cardiac Arrhythmia
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Research Department
state: Michigan
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Erie
country: United States
facility: Consultants in Cardiovascular Diseases
state: Pennsylvania
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute at St. Luke's Episcopal
state: Texas
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
Study officials:
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