Ablation of the Pulmonary Veins for Paroxysmal Afib (MAP-PAF)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT00744874
First received: August 28, 2008
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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)


Condition Intervention Phase
Paroxysmal Atrial Fibrillation
Procedure: RF Ablation procedure
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Array Ablation of the Pulmonary Veins for Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:
  • Number of Participants With Successful Pulmonary Vein Isolation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Chronic Effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Acute Safety [ Time Frame: 7 days post procedure ] [ Designated as safety issue: Yes ]
    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.

  • Chronic Safety [ Time Frame: 7 day post procedure to 6 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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).

  • The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins [ Time Frame: After Procedure ] [ Designated as safety issue: No ]
    Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation

  • Total Procedure Time [ Time Frame: End of Procedure ] [ Designated as safety issue: No ]
    Measurement of total procedure time defined as "skin to skin" and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)

  • Total Fluoroscopy Time [ Time Frame: Post Ablation Procedure ] [ Designated as safety issue: No ]
    Total time that flouroscopy was used during the ablation procedure.


Enrollment: 55
Study Start Date: October 2007
Study Completion Date: July 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: RF Ablation procedure
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.
Other Name: Radio Frequency Ablation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744874

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark
Hjertecenter Varde
Varde, Denmark
Germany
Zentralklinik
Bad Berka, Germany
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Switzerland
Klinik im Park
Zurich, Switzerland
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Medtronic
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT00744874     History of Changes
Other Study ID Numbers: AFI-40
Study First Received: August 28, 2008
Results First Received: July 25, 2012
Last Updated: December 11, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Medtronic Atrial Fibrillation Solutions:
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014