Ablation of the Pulmonary Veins for Paroxysmal Afib (MAP-PAF)
17 de septiembre de 2018 actualizado por: Medtronic Cardiac Rhythm and Heart Failure
Multi-Array Ablation of the Pulmonary Veins for Paroxysmal Atrial Fibrillation
The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal atrial fibrillation.
(PAF)
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This trial was a non-randomized, multi-center, prospective study of subjects with symptomatic, paroxysmal atrial fibrillation (PAF).
The purpose of this study was to investigate and confirm the safety, efficacy and efficiency of the Medtronic Ablation Frontiers® Cardiac Ablation System when used for the treatment of paroxysmal AF.
The trial was conducted over a 2 year period with enrollment occurring between 4 October 2007 and 1 December 2008.
Tipo de estudio
Intervencionista
Inscripción (Actual)
55
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bad Berka, Alemania
- Zentralklinik
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Copenhagen, Dinamarca
- Rigshospitalet
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Varde, Dinamarca
- Hjertecenter Varde
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Nieuwegein, Países Bajos
- St. Antonius Ziekenhuis
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Zurich, Suiza
- Klinik im Park
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
History of symptomatic paroxysmal atrial fibrillation defined as:
- Self terminating AF lasting no more than 7 days
- AF events demostrating spontaneous conversion back to sinus rhythm
- Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year
- AF symptoms defined as the manisfestation of any of the following: Palpitations, Fatigue, Exertional dyspnea, effort intolerance
- Age between 18 and 70
- 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
- Prior ablation for arrhythmias other than AF within the past three months
- Prior left sided AF ablation
- Enrollment in any other ongoing arrhythmia study protocol
- Any ventricular tachyarrhythmias 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 TIAs
- Pregnancy or lactation
- 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 COPD (identified by an FEV1 < 1)
- Severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Ablated Patients
Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.
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Patients with a history of symptomatic paroxysmal (self-terminating) AF and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Successful Pulmonary Vein Isolation
Periodo de tiempo: 6 months
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Acute effectiveness was defined as successful isolation of all pulmonary veins.
Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.
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6 months
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Chronic Effectiveness
Periodo de tiempo: 6 months
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The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit.
In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months.
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6 months
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Acute Safety
Periodo de tiempo: 7 days post procedure
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The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure.
The relatedness of each event was assessed by the investigator at each site.
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7 days post procedure
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Chronic Safety
Periodo de tiempo: 7 day post procedure to 6 months
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The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation.
The relatedness of each event was assessed by the investigator at each site.
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7 day post procedure to 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months
Periodo de tiempo: 6 Months
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Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study.
Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise.
Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe).
Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic).
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6 Months
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The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline
Periodo de tiempo: 6 months
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The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures.
In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit.
The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest).
The subscales are averaged together for a total score between 0 to 100.
A higher score represents a better outcome when compared to a lower score.
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6 months
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Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins
Periodo de tiempo: After Procedure
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Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation
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After Procedure
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Total Procedure Time
Periodo de tiempo: End of Procedure
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Measurement of total procedure time defined as "skin to skin" and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)
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End of Procedure
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Total Fluoroscopy Time
Periodo de tiempo: Post Ablation Procedure
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Total time that flouroscopy was used during the ablation procedure.
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Post Ablation Procedure
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2007
Finalización primaria (Actual)
1 de septiembre de 2009
Finalización del estudio (Actual)
1 de julio de 2011
Fechas de registro del estudio
Enviado por primera vez
28 de agosto de 2008
Primero enviado que cumplió con los criterios de control de calidad
29 de agosto de 2008
Publicado por primera vez (Estimar)
1 de septiembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
17 de septiembre de 2018
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AFI-40
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