HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate
NCT ID: NCT02655731
Last Updated: 2019-08-13
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
100 participants
INTERVENTIONAL
2015-12-31
2018-03-20
Brief Summary
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The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).
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Detailed Description
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Results of studies investigating the impact of LVA may have been confounded by PV-to-left-atrial (LA) reconnection due to non-durable ablation. Therefore, the true contribution of LA-LVA to AF recurrences remains unknown.
Meanwhile, new ablation technologies such as the HeartLight™ laser balloon (LB) ablation system providing near complete chronic PVI rates have been developed.
Aim of the present prospective, single-centre study is to determine the outcome after pure PVI using HeartLight™ in 100 patients with different extents of LA-LVA.
The latter will be assessed by an electro-anatomical voltage map using a commercial 3D mapping system (CARTO, Biosense Webster).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
PVI with HeartLight
PVI with HeartLight
Catheter ablation
Interventions
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PVI with HeartLight
Catheter ablation
Eligibility Criteria
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Inclusion Criteria
* Left atrial size \<50mm
* Left ventricular ejection fraction \<45%
* Patient is able to provide informed consent
Exclusion Criteria
* Previous PVI attempts
* Inability to be treated with oral anticoagulation
* Presence of intracardiac thrombi
* Pregnancy
* Participation in other clinical studies
* Unwilling to follow the study protocol and to attend follow-up visits
18 Years
80 Years
ALL
No
Sponsors
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Cardioangiologisches Centrum Bethanien
OTHER
Responsible Party
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Boris Schmidt
Head of Department
Principal Investigators
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Boris Schmidt, MD
Role: PRINCIPAL_INVESTIGATOR
Cardioangiologisches Centrum Bethanien
Locations
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Cardioangiologisches Centrum Bethanien
Frankfurt am Main, , Germany
Countries
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Other Identifiers
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FF117/2015
Identifier Type: -
Identifier Source: org_study_id
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