HeartLight Guided - Pure Pulmonary Vein Isolation Regardl... | NCT02655731

Studies
HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate

NCT02655731

Sponsor

Cardioangiologisches Centrum Bethanien

Status

Completed

Last Update Posted

Aug 13, 2019Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

PVI with HeartLight

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Mar 20, 2018Actual

Completion Date

Mar 20, 2018Actual

First Submitted Date

Dec 23, 2015

First Submission Date that Met QC Criteria

Jan 13, 2016

First Posted Date

Jan 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2019

Last Update Posted Date

Aug 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Boris Schmidt, Head of Department, Cardioangiologisches Centrum BethanienPrincipal Investigator

Lead Sponsor

Cardioangiologisches Centrum BethanienOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

The ablation strategy for patients with atrial fibrillation (AF) and concomitant atrial substrate (e.g. low-voltage areas; LVA) is a matter of controversy.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Other	PVI with HeartLight	Device: PVI with HeartLight

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PVI with HeartLight	Device	Catheter ablation	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Freedom from atrial fibrillation and atrial tachyarrhythmias	72h Holter-ECG recordings will be performed. In case of clinical arrhythmia symptoms event-recording will be provided.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic atrial fibrillation
Left atrial size <50mm
Left ventricular ejection fraction <45%
Patient is able to provide informed consent

Exclusion Criteria:

Contraindications for PVI
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boris Schmidt, MD	Cardioangiologisches Centrum Bethanien	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardioangiologisches Centrum Bethanien		Frankfurt am Main		60431	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided