PVAC GOLD Versus Irrigated RF Single Tip Catheter With Contact FORCE Ablation of the Pulmonary Veins for Treatment of Drug Refractory Symptomatic Paroxysmal and Persistent Atrial Fibrillation
NCT ID: NCT02463851
Last Updated: 2021-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
212 participants
INTERVENTIONAL
2015-06-30
2021-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AF-Ablation with Multi-electrode catheter
Regular AF-ablation with a multi-electrode ablation catheter
PVAC GOLD multielectrode catheter
Cardiac ablation for Atrial Fibrillation
AF-Ablation with Contact Force single-tip electrode
Regular AF-ablation with a regular Contact Force single-tip ablation catheter
Contact Force single-tip ablation catheter
Interventions
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PVAC GOLD multielectrode catheter
Cardiac ablation for Atrial Fibrillation
Contact Force single-tip ablation catheter
Eligibility Criteria
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Inclusion Criteria
* Self-terminating AF with episodes lasting no more than seven consecutive days before 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 manifestation of any of the following:
* Palpitations
* Fatigue
* Exertional dyspnea
* Effort intolerance
2. 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
* Previous cardiac surgery (excluding CABG)
* Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction \< 40% measured by acceptable cardiac testing
* Left atrial diameter of \> 45mm as measured in the parasternal long axis on transthoracic echocardiogram
* LA volume\>40 ml/m2
* Stable/unstable angina or ongoing myocardial ischemia
* Myocardial infarction (MI) within three months of enrollment
* Aortic or mitral valve disease \> Grade II
* Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
* Prior ASD or PFO closure with a device using a percutaneous approach
* Hypertrophic cardiomyopathy (LV wall thickness \> 1.5 cm)
* Pulmonary hypertension (mean or systolic PA pressure \>50mm Hg on Doppler echo
2. Prior ablation for arrhythmias other than AF within the past three months
3. Prior left sided AF ablation
4. Enrollment in any other ongoing arrhythmia study protocol Any ventricular tachy-arrhythmias currently being treated where the arrhythmia or the management may interfere with this study
18 Years
ALL
No
Sponsors
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L.V.A. Boersma
OTHER
Responsible Party
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L.V.A. Boersma
Cardiologist
Locations
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Praxisklinik Herz und Gefäße
Dresden, , Germany
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, Utrecht, Netherlands
Isala Klinieken
Zwolle, , Netherlands
Countries
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Other Identifiers
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RDC-2014.01
Identifier Type: -
Identifier Source: org_study_id
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