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TerminatedNCT00111488Updated Jan 6, 2016

Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation

A Phase 3 interventional study of Flex 4 and Generator in Atrial Fibrillation, sponsored by Boston Scientific Corporation. Terminated at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-06.

Sponsored by Boston Scientific Corporation · Phase 3, Interventional, and Treatment

Why this study was terminated
Slow enrollment
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the Randomized Study of Surgical Ablation with Microwave Energy for the Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and effectiveness of the Guidant FLEX® Microwave Surgical Ablation System in the treatment of permanent atrial fibrillation (AF).

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • atrial fibrillation
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 200 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 527 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient age >= 18 years
  • Documented permanent AF (for at least three months)
  • Scheduled for an open chest cardiac surgery for the primary indication of mitral valve repair or replacement
  • Has been informed of the nature of the study, agrees to its provisions, and provided written informed consent, which was approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site

Exclusion criteria

Exclusion Criteria:

  • Cerebral vascular accident (CVA, stroke) or transient ischemic attack (TIA) within the previous 6 months
  • Myocardial infarction within the previous 6 weeks
  • Documented history of pulmonary vein stenosis
  • Previous ablation attempt for AF
  • Previous thoracic procedures
  • Left atrial size > 7.0 cm
  • Left ventricular ejection fraction \< 30%
  • Presence of left atrial or left atrial appendage thrombi
  • Esophageal fistula or other stricture, untreated esophagitis, varices, dysphagia or odynophagia contraindicating transesophageal echocardiography
  • Known allergy or contraindication to warfarin therapy
  • Known allergy or contraindication to antiarrhythmic (Classes IA, IC, III) therapy
  • Other comorbidity with reduced life expectancy of less than 1 year or protocol noncompliance that would limit follow-up
  • Geographically remote or unable to return for follow-up examinations
  • Pregnant or planning to become pregnant during the study
  • Enrolled in any concurrent study, without Guidant written approval, that may confound the results of the study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single
Enrollment
200 participants

Interventions

  • DeviceFlex 4 and Generator
06

What researchers measure

Primary outcomes

  1. Freedom from atrial fibrillation at six months

  2. Composite major adverse event at one month

    Time frame: One month

Secondary outcomes

  1. Composite Majour Adverse Events at three and 6 months

    Time frame: 3 months and 6 months

  2. Restoration of normal sinus rhythm at discharge

    Time frame: Hospital discharge

  3. Change in cardiac function at six month

    Time frame: 6 month

  4. Change in Quality of Life at six months

    Time frame: 6 months

07

Study locations

21 sites
  • Scripps Memorial/ Kaiser Permanente
    La Jolla, California 92037, United States
  • Long Beach Memorial Medical Center
    Long Beach, California 90806, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • Mercy General Hospital
    Sacramento, California 95819, United States
  • Piedmont Hospital
    Atlanta, Georgia 30309, United States
  • Methodist Hospital
    Indianapolis, Indiana 46202, United States
  • St. Francis Hospital and Health Center
    Indianapolis, Indiana 46237, United States
  • Alegent Health
    Omaha, Nebraska 48910, United States
  • St. Michael's Medical Center
    Newark, New Jersey 07102, United States
  • Valley Hospital
    Ridgewood, New Jersey 07450, United States
  • Lenox Hill Hospital
    New York, New York 10021, United States
  • Univesity of Rochester Medical
    Rochester, New York 14642, United States
  • Providence St. Vincent Medical Center
    Portland, Oregon 97225, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Cardiopulmonary Research Science and Technology Institute
    Dallas, Texas 75230, United States
  • Baylor University
    Dallas, Texas 75246, United States
  • Plaza Medical Center
    Fort Worth, Texas 76104, United States
  • University of VIrginia Health System
    Charlottesville, Virginia 22908, United States
  • Virginia Masonic Clinic
    Seattle, Washington 98111, United States
  • Wisconsin Heart Hospital
    Milwaukee, Wisconsin 53210, United States
  • Wausau Heart and Lung Surgeons
    Wausau, Wisconsin 54401, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00111488
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
May 23, 2005
Start date
Jun 2005
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Jan 6, 2016

Study contacts

Michael Mack, MD
principal investigator · Cardiopulmonary Research Science and Technology Institute
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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