Concomitant Epicardial Pulmonary Vein Isolation in Patien... | NCT01360918

Studies
Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery

NCT01360918

Sponsor

Medisch Spectrum Twente

Status

Terminated

Last Update Posted

Jul 7, 2016Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

Epicardial pulmonary vein isolation
Usual care

Countries

Netherlands

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inclusion rate insufficiënt

Expanded Access Info

Start Date

May 2011

Primary Completion Date

May 2013Actual

Completion Date

May 2014Actual

First Submitted Date

May 13, 2011

First Submission Date that Met QC Criteria

May 25, 2011

First Posted Date

May 26, 2011Estimated

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

Jul 6, 2016

Last Update Posted Date

Jul 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

B. Oude Velthuis, B. Oude Velthuis MD., Medisch Spectrum TwentePrincipal Investigator

Lead Sponsor

Medisch Spectrum TwenteOTHER

Collaborators

Name	Class
Foundation of Cardiovascular Research and Education Enschede	OTHER

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

Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the concomitant treatment of AF. The investigators aim to establish the effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac surgery.

Detailed Description

Not provided

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

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual care	Active Comparator		Other: Usual care
Pulmonary vein isolation	Active Comparator		Device: Epicardial pulmonary vein isolation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epicardial pulmonary vein isolation	Device	After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence of atrial fibrillation	The percentage of patients without a recurrence of AF, without antiarrhythmic drugs (AADs), within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure. An episode of AF is defined as an episode of at least 30 seconds duration.	one year

Secondary Outcomes

Measure	Description	Time Frame
Duration of hospitalization	Secondary objectives include the duration of hospitalization	One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients ≥ 18 years of age
EHRA class ≤ 2
Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery
Patients will have elective coronary surgery planned Able of providing informed consent

Exclusion Criteria:

Patients ≥70 years of age
Pregnancy Patients with contraindications for oral anticoagulant agents
Patients undergoing emergency operation
Patients undergoing concomitant valve replacement
Severely enlarged LA (>50 mm) on echocardiography
Prior AF ablation or AF surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 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
Marcoen Scholten, MD PhD	Medisch Spectrum Twente	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medisch Spectrum Twente		Enschede	Overijssel		Netherlands

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

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Browse Branches

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