Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF)
17 settembre 2018 aggiornato da: Medtronic Cardiac Rhythm and Heart Failure
Tailored Treatment of Permanent Atrial Fibrillation - TTOP-AF
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
210
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Nieuwegein, Olanda
- St. Antonius Ziekenhuis
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85251
- Arizona Arrhythmia Research Center
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California
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Los Angeles, California, Stati Uniti, 90095
- UCLA Cardiac Arrhythmia Center
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Florida
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Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic Jacksonville
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Georgia
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Atlanta, Georgia, Stati Uniti, 30309
- Piedmont Hospital
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Atlanta, Georgia, Stati Uniti, 30308
- Emory Crawford Long Hospital
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Illinois
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Chicago, Illinois, Stati Uniti, 60637
- University of Chicago
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202
- Krannert Institute of Cardiology
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Iowa
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Davenport, Iowa, Stati Uniti, 52803
- Genesis Medical Center
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Des Moines, Iowa, Stati Uniti, 50309
- Iowa Heart Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins Hospital
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Takoma Park, Maryland, Stati Uniti, 20912
- Washington Adventist Hospital
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital Cardiac Arrhythmia
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Burlington, Massachusetts, Stati Uniti, 01805
- Lahey Clinic
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan
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Grand Rapids, Michigan, Stati Uniti, 49503
- Spectrum Health Research Department
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New York
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Rochester, New York, Stati Uniti, 14642
- University of Rochester
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North Carolina
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Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest University
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Ohio
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Columbus, Ohio, Stati Uniti, 43210
- The Ohio State University
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Pennsylvania
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Erie, Pennsylvania, Stati Uniti, 16502
- Consultants in Cardiovascular Diseases
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Texas
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Austin, Texas, Stati Uniti, 78756
- Austin Heart
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Houston, Texas, Stati Uniti, 77030
- Texas Heart Institute at St. Luke's Episcopal
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Virginia
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Norfolk, Virginia, Stati Uniti, 23507
- Sentara Cardiovascular Research Institute
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 70 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 1
Ablation Management
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Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium.
Cardioversion could be used to restore sinus rhythm if needed.
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Comparatore attivo: 2
Medical Management
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Arm 2 (Medical Management): Class I or III antiarrhythmic drugs.
Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed.
Direct current cardioversions were also allowed at the discretion of the investigator.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Chronic Effectiveness
Lasso di tempo: 6 months
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The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:
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6 months
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Acute Safety
Lasso di tempo: 7 days
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The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point.
Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.
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7 days
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Chronic Safety
Lasso di tempo: 6 months
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The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months.
Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure.
Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint.
Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.
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6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Acute Efficacy
Lasso di tempo: Procedure conclusion
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A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:
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Procedure conclusion
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Improvement of Left Atrial Size at 6 Months Compared to Baseline.
Lasso di tempo: 6 months
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Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms.
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6 months
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Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.
Lasso di tempo: 6 months
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Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.
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6 months
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Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.
Lasso di tempo: 6 months
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The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe).
The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise.
The scores were tabulated at the 1, 3 and 6 month follow-up visits.
Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic.
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6 months
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Improved Quality of Life Over 6 Months Compared to Baseline.
Lasso di tempo: 6 months
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The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits.
The SF-36 is a multi-purpose, short-form health survey with only 36 questions.
It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score.
The possible range for Physical Component Score and Mental Component Score is 0 to 100.
The higher score, the better quality of life.
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6 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Hindricks G, Piorkowski C, Tanner H, Kobza R, Gerds-Li JH, Carbucicchio C, Kottkamp H. Perception of atrial fibrillation before and after radiofrequency catheter ablation: relevance of asymptomatic arrhythmia recurrence. Circulation. 2005 Jul 19;112(3):307-13. doi: 10.1161/CIRCULATIONAHA.104.518837. Epub 2005 Jul 11.
- Vasamreddy CR, Dalal D, Dong J, Cheng A, Spragg D, Lamiy SZ, Meininger G, Henrikson CA, Marine JE, Berger R, Calkins H. Symptomatic and asymptomatic atrial fibrillation in patients undergoing radiofrequency catheter ablation. J Cardiovasc Electrophysiol. 2006 Feb;17(2):134-9. doi: 10.1111/j.1540-8167.2006.00359.x.
- Marrouche NF, Martin DO, Wazni O, Gillinov AM, Klein A, Bhargava M, Saad E, Bash D, Yamada H, Jaber W, Schweikert R, Tchou P, Abdul-Karim A, Saliba W, Natale A. Phased-array intracardiac echocardiography monitoring during pulmonary vein isolation in patients with atrial fibrillation: impact on outcome and complications. Circulation. 2003 Jun 3;107(21):2710-6. doi: 10.1161/01.CIR.0000070541.83326.15. Epub 2003 May 19.
- Wazni OM, Marrouche NF, Martin DO, Verma A, Bhargava M, Saliba W, Bash D, Schweikert R, Brachmann J, Gunther J, Gutleben K, Pisano E, Potenza D, Fanelli R, Raviele A, Themistoclakis S, Rossillo A, Bonso A, Natale A. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA. 2005 Jun 1;293(21):2634-40. doi: 10.1001/jama.293.21.2634.
- Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.
- Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Aug 15;114(7):e257-354. doi: 10.1161/CIRCULATIONAHA.106.177292. No abstract available. Erratum In: Circulation. 2007 Aug 7;116(6):e138.
- Oral H, Pappone C, Chugh A, Good E, Bogun F, Pelosi F Jr, Bates ER, Lehmann MH, Vicedomini G, Augello G, Agricola E, Sala S, Santinelli V, Morady F. Circumferential pulmonary-vein ablation for chronic atrial fibrillation. N Engl J Med. 2006 Mar 2;354(9):934-41. doi: 10.1056/NEJMoa050955.
- Saad EB, Rossillo A, Saad CP, Martin DO, Bhargava M, Erciyes D, Bash D, Williams-Andrews M, Beheiry S, Marrouche NF, Adams J, Pisano E, Fanelli R, Potenza D, Raviele A, Bonso A, Themistoclakis S, Brachmann J, Saliba WI, Schweikert RA, Natale A. Pulmonary vein stenosis after radiofrequency ablation of atrial fibrillation: functional characterization, evolution, and influence of the ablation strategy. Circulation. 2003 Dec 23;108(25):3102-7. doi: 10.1161/01.CIR.0000104569.96907.7F. Epub 2003 Nov 17.
- Pappone C, Rosanio S, Augello G, Gallus G, Vicedomini G, Mazzone P, Gulletta S, Gugliotta F, Pappone A, Santinelli V, Tortoriello V, Sala S, Zangrillo A, Crescenzi G, Benussi S, Alfieri O. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol. 2003 Jul 16;42(2):185-97. doi: 10.1016/s0735-1097(03)00577-1.
- Fuster V, Ryden LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Levy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC, Klein WW, Alonso-Garcia A, Blomstrom-Lundqvist C, De Backer G, Flather M, Hradec J, Oto A, Parkhomenko A, Silber S, Torbicki A; American College of Cardiology/American Heart Association/European Society of Cardiology Board. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: executive summary. A Report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation): developed in Collaboration With the North American Society of Pacing and Electrophysiology. J Am Coll Cardiol. 2001 Oct;38(4):1231-66. doi: 10.1016/s0735-1097(01)01587-x. No abstract available.
- Benussi S, Nascimbene S, Calori G, Denti P, Ziskind Z, Kassem S, La Canna G, Pappone C, Alfieri O. Surgical ablation of atrial fibrillation with a novel bipolar radiofrequency device. J Thorac Cardiovasc Surg. 2005 Aug;130(2):491-7. doi: 10.1016/j.jtcvs.2005.01.009.
- Dill T, Neumann T, Ekinci O, Breidenbach C, John A, Erdogan A, Bachmann G, Hamm CW, Pitschner HF. Pulmonary vein diameter reduction after radiofrequency catheter ablation for paroxysmal atrial fibrillation evaluated by contrast-enhanced three-dimensional magnetic resonance imaging. Circulation. 2003 Feb 18;107(6):845-50. doi: 10.1161/01.cir.0000048146.81336.1d.
- Dong J, Vasamreddy CR, Jayam V, Dalal D, Dickfeld T, Eldadah Z, Meininger G, Halperin HR, Berger R, Bluemke DA, Calkins H. Incidence and predictors of pulmonary vein stenosis following catheter ablation of atrial fibrillation using the anatomic pulmonary vein ablation approach: results from paired magnetic resonance imaging. J Cardiovasc Electrophysiol. 2005 Aug;16(8):845-52. doi: 10.1111/j.1540-8167.2005.40680.x.
- Food and Drug Administration Guidance for Industry and FDA Staff: Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation, January 9, 2004.
- Abreu Filho CA, Lisboa LA, Dallan LA, Spina GS, Grinberg M, Scanavacca M, Sosa EA, Ramires JA, Oliveira SA. Effectiveness of the maze procedure using cooled-tip radiofrequency ablation in patients with permanent atrial fibrillation and rheumatic mitral valve disease. Circulation. 2005 Aug 30;112(9 Suppl):I20-5. doi: 10.1161/CIRCULATIONAHA.104.526301.
- Fisher JD, Spinelli MA, Mookherjee D, Krumerman AK, Palma EC. Atrial fibrillation ablation: reaching the mainstream. Pacing Clin Electrophysiol. 2006 May;29(5):523-37. doi: 10.1111/j.1540-8159.2006.00388.x.
- Gajewski J, Singer RB. Mortality in an insured population with atrial fibrillation. JAMA. 1981 Apr 17;245(15):1540-4.
- de Lima GG, Kalil RA, Leiria TL, Hatem DM, Kruse CL, Abrahao R, Sant'anna JR, Prates PR, Nesralla IA. Randomized study of surgery for patients with permanent atrial fibrillation as a result of mitral valve disease. Ann Thorac Surg. 2004 Jun;77(6):2089-94; discussion 2094-5. doi: 10.1016/j.athoracsur.2003.11.018.
- Hornero F, Rodriguez I, Bueno M, Buendia J, Dalmau MJ, Canovas S, Gil O, Garcia R, Montero JA. Surgical ablation of permanent atrial fibrillation by means of maze radiofrequency: mid-term results. J Card Surg. 2004 Sep-Oct;19(5):383-8. doi: 10.1111/j.0886-0440.2004.04077.x.
- Kerr CR, Humphries KH, Talajic M, Klein GJ, Connolly SJ, Green M, Boone J, Sheldon R, Dorian P, Newman D. Progression to chronic atrial fibrillation after the initial diagnosis of paroxysmal atrial fibrillation: results from the Canadian Registry of Atrial Fibrillation. Am Heart J. 2005 Mar;149(3):489-96. doi: 10.1016/j.ahj.2004.09.053.
- Packer DL, Asirvatham S, Munger TM. Progress in nonpharmacologic therapy of atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Dec;14(12 Suppl):S296-309. doi: 10.1046/j.1540-8167.2003.90403.x. No abstract available.
- PMA P020025 - Summary of Safety and Effectiveness Data: Boston Scientific Corporation Blazer II XP™ Cardiac Ablation Catheter, August 25, 2003.
- PMA P030031 - Summary of Safety and Effectiveness Data: Biosense Webster Navistar™/Celsius™ThermoCool® Diagnostic/Ablation Deflectable Tip Catheters, November 5, 2004.
- PMA P040042 - Summary of Safety and Effectiveness Data: Irvine Biomedical, Inc. IBI Therapy™ Dual 8™ Ablation Catheter, November 18, 2005.
- Saad EB, Cole CR, Marrouche NF, Dresing TJ, Perez-Lugones A, Saliba WI, Schweikert RA, Klein A, Rodriguez L, Grimm R, Tchou P, Natale A. Use of intracardiac echocardiography for prediction of chronic pulmonary vein stenosis after ablation of atrial fibrillation. J Cardiovasc Electrophysiol. 2002 Oct;13(10):986-9. doi: 10.1046/j.1540-8167.2002.00986.x.
- Scardi S, Mazzone C, Pandullo C, Goldstein D, Poletti A, Humar F. Lone atrial fibrillation: prognostic differences between paroxysmal and chronic forms after 10 years of follow-up. Am Heart J. 1999 Apr;137(4 Pt 1):686-91. doi: 10.1016/s0002-8703(99)70224-3.
- Vasamreddy CR, Dalal D, Eldadah Z, Dickfeld T, Jayam VK, Henrickson C, Meininger G, Dong J, Lickfett L, Berger R, Calkins H. Safety and efficacy of circumferential pulmonary vein catheter ablation of atrial fibrillation. Heart Rhythm. 2005 Jan;2(1):42-8. doi: 10.1016/j.hrthm.2004.10.027.
- Chen YJ, Chen SA, Tai CT, Wen ZC, Feng AN, Ding YA, Chang MS. Role of atrial electrophysiology and autonomic nervous system in patients with supraventricular tachycardia and paroxysmal atrial fibrillation. J Am Coll Cardiol. 1998 Sep;32(3):732-8. doi: 10.1016/s0735-1097(98)00305-2.
- Haissaguerre M, Sanders P, Hocini M, Hsu LF, Shah DC, Scavee C, Takahashi Y, Rotter M, Pasquie JL, Garrigue S, Clementy J, Jais P. Changes in atrial fibrillation cycle length and inducibility during catheter ablation and their relation to outcome. Circulation. 2004 Jun 22;109(24):3007-13. doi: 10.1161/01.CIR.0000130645.95357.97. Epub 2004 Jun 7.
- Sanders P, Nalliah CJ, Dubois R, Takahashi Y, Hocini M, Rotter M, Rostock T, Sacher F, Hsu LF, Jonsson A, O'Neill MD, Jais P, Haissaguerre M. Frequency mapping of the pulmonary veins in paroxysmal versus permanent atrial fibrillation. J Cardiovasc Electrophysiol. 2006 Sep;17(9):965-72. doi: 10.1111/j.1540-8167.2006.00546.x.
- Jais P, Hocini M, Sanders P, Hsu LF, Takahashi Y, Rotter M, Rostock T, Sacher F, Clementy J, Haissaguerre M. Long-term evaluation of atrial fibrillation ablation guided by noninducibility. Heart Rhythm. 2006 Feb;3(2):140-5. doi: 10.1016/j.hrthm.2005.11.012.
- Earley MJ, Abrams DJ, Staniforth AD, Sporton SC, Schilling RJ. Catheter ablation of permanent atrial fibrillation: medium term results. Heart. 2006 Feb;92(2):233-8. doi: 10.1136/hrt.2005.066969. Epub 2005 Aug 23.
- Nilsson B, Chen X, Pehrson S, Kober L, Hilden J, Svendsen JH. Recurrence of pulmonary vein conduction and atrial fibrillation after pulmonary vein isolation for atrial fibrillation: a randomized trial of the ostial versus the extraostial ablation strategy. Am Heart J. 2006 Sep;152(3):537.e1-8. doi: 10.1016/j.ahj.2006.05.029.
- Rotter M, Takahashi Y, Sanders P, Haissaguerre M, Jais P, Hsu LF, Sacher F, Pasquie JL, Clementy J, Hocini M. Reduction of fluoroscopy exposure and procedure duration during ablation of atrial fibrillation using a novel anatomical navigation system. Eur Heart J. 2005 Jul;26(14):1415-21. doi: 10.1093/eurheartj/ehi172. Epub 2005 Mar 1.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2007
Completamento primario (Effettivo)
1 novembre 2010
Completamento dello studio (Effettivo)
1 novembre 2010
Date di iscrizione allo studio
Primo inviato
8 agosto 2007
Primo inviato che soddisfa i criteri di controllo qualità
8 agosto 2007
Primo Inserito (Stima)
10 agosto 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
16 ottobre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 settembre 2018
Ultimo verificato
1 settembre 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AFI-30
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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