Atrial FibrillationNCT00415558
Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of PAF in the MIS Procedure
A study testing Microwave Ablation System in people with Atrial Fibrillation, run by Maquet Cardiovascular at 5 sites in United States.
Trial summary
The purpose of this prospective, single-arm, un-blinded, multi-site clinical study is to assess the safety and efficacy of the Microwave Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) in the minimally invasive surgical (MIS) procedure in approximately 30 patients at 6… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Microwave Ablation System
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- May 2007to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patient is greater than or = 18 years of age
- Patient has documented symptomatic paroxysmal atrial fibrillation (PAF) refractory to at least 1 antiarrhythmic (Class IA, IC, III) drug.
- Patient has episodes of symptomatic AF including, but not limited to, palpitations, lightheadedness, fatigue, dyspnea, and/or chest pain.
- A minimum of a 6-month history of symptomatic paroxysmal AF (documented by patient report in the medical record).
- A minimum of 2 discrete symptomatic paroxysmal AF episodes in the month prior to study entry. Paroxysmal AF rhythm must be documented by objective evidence (12-lead electrocardiogram [ECG], Holter monitor, event monitor, or other telemetry rhythm strip) with the presence of sinus rhythm and/or underlying rhythm between episodes.
- Patient has been informed of the nature of the study, agreed to its provisions, and provided written informed consent.
Who cannot join
- Patient had a cerebral vascular accident or transient ischemic attack within the previous 6 months.
- Patient had a myocardial infarction within the previous 6 weeks.
- Patient has underlying metabolic etiology related to AF (e.g., hyperthyroidism, metabolic disorder).
- Patient has significant underlying structural heart disease (e.g., valvular disease, presence of aneurysm, left ventricular hypertrophy) requiring surgical or procedural intervention.
- Patient with prior catheter ablation procedure for the treatment of AF within the previous 6 months.
- Patient has evidence of, or history of, 50% or more stenosis in any pulmonary vein.
Show all 19Show fewer
- Patient had a previous thoracic procedure resulting in sternal opening and/or pericardial opening (e.g., surgical ablation, coronary artery bypass graft [CABG], or valve repair).
- Patient has a left atrial size > 6.0 cm measured on echocardiogram.
- Patient has a left ventricular ejection fraction (LVEF) < 35%.
- Patient requires treatment for CAD (coronary artery disease) or has untreated unstable angina.
- Patient has a presence of esophageal fistula or esophageal stricture, untreated esophagitis, varices, dysphagia, or odynophagia caused by anatomical abnormality or other diseases contraindicating transesophageal echocardiography.
- Patient has severe chronic obstructive pulmonary disease.
- Patient has a known allergy or contraindication to Coumadin (warfarin) therapy, or inability to comply with Coumadin (warfarin) therapy.
- Patient has a known allergy or contraindication to complying with antiarrhythmic (Class IA, IC, III) therapy.
- Patient has an acute illness or active systemic infection or sepsis.
- Patient has a co-morbidity with life expectancy of less than one year or protocol non-compliance that would limit follow-up.
- Patient is geographically remote and/or unable to return for follow-up examinations.
- Patient is pregnant or is planning to become pregnant during the study.
- Patient is enrolled in any concurrent study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Chico, California
Study site
Long Beach, California
Study site
Madison, Wisconsin
Study site
Mesa, Arizona
Study site
Saginaw, Michigan
About this study
Official title: Prospective, Multicenter, Un-Blinded, Single Arm, Clinical Study Using the Guidant Microwave Ablation System Comprised of the Flex 10 Ablation Probe and Microwave Generator for Patients With Symptomatic Paroxysmal Atrial Fibrillation
The purpose of this prospective, single-arm, un-blinded, multi-site clinical study is to assess the safety and efficacy of the Microwave Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) in the minimally invasive surgical (MIS) procedure in approximately 30 patients at 6 investigational sites in the United States.
Read the detailed description
The study population for this study will be comprised of patients who have been diagnosed with symptomatic (PAF) for at least 6 months prior to study entry. Patients will be qualified for the study if they meet stringent inclusion/exclusion criteria, signing an informed consent and agreeing to return for followup visits at 1, 3, 6, 9 and 12 months. All study patients will receive microwave ablation to treat their symptomatic PAF. The Microwave Ablation System will be used during a MIS procedure on a beating heart in order to ablate a specified lesion pattern.
- Conditions
- Atrial Fibrillation
- Being tested
- Microwave Ablation System
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave Ablation SystemDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startMay 2007
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Maquet Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Li Poa, MD, Principal investigator, Enloe Medical CenterDudley Hudspeth, MD, Principal investigator, Banner Desert Medical CenterDaniel Bethencourt, MD, Principal investigator, Long Beach Memorial Medical CenterNiloo Edwards, MD, Principal investigator, University of Wisconsin Hospitals and ClinicsNorbert Baumgartner, MD, Principal investigator, Covenant Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415558
- Sponsor's protocol ID
- VR2049541
- Status last verified
- Jun 2009
- First submitted
- 20 Dec 2006
- Last updated
- 9 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Un-Blinded, Single Arm, Clinical Study Using the Guidant Microwave Ablation System Comprised of the Flex 10 Ablation Probe and Microwave Generator for Patients With Symptomatic Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00415558
- Acronym / sponsor ID
- VR2049541
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Lead sponsor
- Maquet CardiovascularIndustry (pharma, biotech, devices)
- Study start
- May 2007
- First posted
- 25 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective, single-arm, un-blinded, multi-site clinical study is to assess the safety and efficacy of the Microwave Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) in the minimally invasive surgical (MIS) procedure in approximately 30 patients at 6 investigational sites in the United States.
Detailed description
The study population for this study will be comprised of patients who have been diagnosed with symptomatic (PAF) for at least 6 months prior to study entry. Patients will be qualified for the study if they meet stringent inclusion/exclusion criteria, signing an informed consent and agreeing to return for followup visits at 1, 3, 6, 9 and 12 months. All study patients will receive microwave ablation to treat their symptomatic PAF. The Microwave Ablation System will be used during a MIS procedure on a beating heart in order to ablate a specified lesion pattern.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is greater than or = 18 years of age
- Patient has documented symptomatic paroxysmal atrial fibrillation (PAF) refractory to at least 1 antiarrhythmic (Class IA, IC, III) drug.
- Patient has episodes of symptomatic AF including, but not limited to, palpitations, lightheadedness, fatigue, dyspnea, and/or chest pain.
- A minimum of a 6-month history of symptomatic paroxysmal AF (documented by patient report in the medical record).
- A minimum of 2 discrete symptomatic paroxysmal AF episodes in the month prior to study entry. Paroxysmal AF rhythm must be documented by objective evidence (12-lead electrocardiogram [ECG], Holter monitor, event monitor, or other telemetry rhythm strip) with the presence of sinus rhythm and/or underlying rhythm between episodes.
Key exclusion criteria (19 listed)
- Patient had a cerebral vascular accident or transient ischemic attack within the previous 6 months.
- Patient had a myocardial infarction within the previous 6 weeks.
- Patient has underlying metabolic etiology related to AF (e.g., hyperthyroidism, metabolic disorder).
- Patient has significant underlying structural heart disease (e.g., valvular disease, presence of aneurysm, left ventricular hypertrophy) requiring surgical or procedural intervention.
- Patient with prior catheter ablation procedure for the treatment of AF within the previous 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave Ablation System | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2009.
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Poa, MD principal investigator
Enloe Medical Center
Dudley Hudspeth, MD principal investigator
Banner Desert Medical Center
Daniel Bethencourt, MD principal investigator
Long Beach Memorial Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave Ablation System in people with Atrial Fibrillation, run by Maquet Cardiovascular at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2009.