Contact Force Guided Ablation Versus Conventional Pulmona... | NCT02816268

Studies
Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

NCT02816268

Sponsor

Deutsches Herzzentrum Muenchen

Status

Completed

Last Update Posted

Jun 28, 2016Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Improving Outcome After Pulmonary Vein Isolation

Interventions

Pulmonary vein isolation

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

Jun 2016

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

Sep 2012

Primary Completion Date

May 2014Actual

Completion Date

Nov 2015Actual

First Submitted Date

Jun 24, 2016

First Submission Date that Met QC Criteria

Jun 27, 2016

First Posted Date

Jun 28, 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

Jun 27, 2016

Last Update Posted Date

Jun 28, 2016Estimated

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 investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.

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

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional Pulmonary vein isolation	Other	Conventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter	Other: Pulmonary vein isolation
Contact force pulmonary vein isolation	Other	Contact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®)	Other: Pulmonary vein isolation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary vein isolation	Other		Contact force pulmonary vein isolation Conventional Pulmonary vein isolation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of reconnected pulmonary vein after ablation and a waíting period of 20min		20min after procedure

Secondary Outcomes

Measure	Description	Time Frame
Time to first documented recurrence of atrial fibrillation		12 month
Complications due to ablation		30 days
Number of reconnected pulmonary veins

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients (>=18 und < 80 years) with symptomatic paroxysmal AF
At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
Oral anticoagulation with phenprocoumone, warfarine or DOAKs for at least 4 weeks prior to ablation with weekly documented INR > 2..
Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.

Exclusion Criteria:

Left atrial thrombus
Contraindications for oral anticoagulation or adenosin

Accepts Healthy Volunteers

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deutsches Herzzentrum München		Munich		80636	Germany

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided