Signal Transfer of Atrial Fibrillation Data to Guide Huma... | NCT01765075

Studies
Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment

NCT01765075

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Mar 5, 2014Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Permanent Atrial Fibrillation

Interventions

Not provided

Countries

Czechia
United Kingdom

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

Mar 2014

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

Apr 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jan 8, 2013

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 10, 2013Estimated

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

Mar 3, 2014

Last Update Posted Date

Mar 5, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of the study is to gather electrophysiological data using a multi-electrode mapping catheter during a clinically indicated cardiac ablation procedure for the treatment of persistent atrial fibrillation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Label	Type	Description	Intervention Names
Patients undergoing cardiac ablation for permanent AF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Record 20 sets of electrophysiological data with a multi-electrode mapping catheter.		Acute - time of procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
Scheduled for a clinically indicated cardiac ablation for the treatment of persistent atrial fibrillation
Able to meet study requirements for follow-up visit

Exclusion Criteria:

Permanent leads or presence of prosthetic or severely stenotic tricuspid or mitral valves
Active systemic infection or sepsis
Echocardiographically confirmed presence of thrombus
Atrial thrombus, myxoma, inter-atrial baffle patch or occluder device for those subjects in whom a transseptal approach is required
Subjects who cannot be anticoagulated or infused with heparinized saline
Heparin induced thrombocytopenia
Hemodynamic instability or shock
Atrial anatomy contradictory to catheter labeling or size indices
EF < 35%
Subjects with an active heart failure decompensation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Permanent atrial fibrillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jas Gill, MA MD FRCP FACC	Guys & St. Thomas' Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Na Homolce		Prague		15030	Czechia
Guys & St. Thomas' Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29858382	Derived	Child N, Clayton RH, Roney CH, Laughner JI, Shuros A, Neuzil P, Petru J, Jackson T, Porter B, Bostock J, Niederer SA, Razavi RS, Rinaldi CA, Taggart P, Wright MJ, Gill J. Unraveling the Underlying Arrhythmia Mechanism in Persistent Atrial Fibrillation: Results From the STARLIGHT Study. Circ Arrhythm Electrophysiol. 2018 Jun;11(6):e005897. doi: 10.1161/CIRCEP.117.005897.