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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
RF Ablation procedure
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring atrial fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Rigshospitalet
  • Hjertecenter Varde
  • Zentralklinik
  • St. Antonius Ziekenhuis
  • Klinik im Park

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ablated Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Successful Pulmonary Vein Isolation
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
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
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
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
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
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
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
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
Total time that flouroscopy was used during the ablation procedure.

Full Information

First Posted
August 28, 2008
Last Updated
September 17, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00744874
Brief Title
Ablation of the Pulmonary Veins for Paroxysmal Afib
Acronym
MAP-PAF
Official Title
Multi-Array Ablation of the Pulmonary Veins for Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ablated Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
RF Ablation procedure
Other Intervention Name(s)
Radio Frequency Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Successful Pulmonary Vein Isolation
Description
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.
Time Frame
6 months
Title
Chronic Effectiveness
Description
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.
Time Frame
6 months
Title
Acute Safety
Description
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.
Time Frame
7 days post procedure
Title
Chronic Safety
Description
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.
Time Frame
7 day post procedure to 6 months
Secondary Outcome Measure Information:
Title
Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months
Description
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).
Time Frame
6 Months
Title
The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline
Description
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.
Time Frame
6 months
Title
Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins
Description
Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation
Time Frame
After Procedure
Title
Total Procedure Time
Description
Measurement of total procedure time defined as "skin to skin" and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)
Time Frame
End of Procedure
Title
Total Fluoroscopy Time
Description
Total time that flouroscopy was used during the ablation procedure.
Time Frame
Post Ablation Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Hjertecenter Varde
City
Varde
Country
Denmark
Facility Name
Zentralklinik
City
Bad Berka
Country
Germany
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Klinik im Park
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.ablationfrontiers.com
Description
Company website

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Ablation of the Pulmonary Veins for Paroxysmal Afib

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