Biomarkers in Patients Undergoing Atrial Fibrillation Abl... | NCT03388333

Studies
Biomarkers in Patients Undergoing Atrial Fibrillation Ablation

NCT03388333

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Last Update Posted

Jun 7, 2019Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

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

Oct 2018

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

Jan 2017Actual

Primary Completion Date

Jul 2018Actual

Completion Date

Apr 2019Actual

First Submitted Date

Dec 22, 2017

First Submission Date that Met QC Criteria

Dec 22, 2017

First Posted Date

Jan 2, 2018Actual

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 6, 2019

Last Update Posted Date

Jun 7, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. Christian Meyer, Prof. Dr. Christian Meyer, Universitätsklinikum Hamburg-EppendorfPrincipal Investigator

Lead Sponsor

Universitätsklinikum Hamburg-EppendorfOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 aim to find biomarkers to determine the success of pulmonary vein isolation for the treatment of atrial fibrillation.

Detailed Description

The investigators perform an observational study in patients undergoing pulmonary vein ablation to treat atrial fibrillation. Additionally, electrophysiological procedures not related to pulmonary vein isolation are also followed. The aim of the study is finding biomarkers that are able to predict short-term outcome of the procedure.The primary endpoint is defined as reoccurrences of atrial fibrillation within the first three months after pulmonary vein isolation.

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

Retention

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Atrial fibrillation ablation group	Patients undergoing catheter ablation for the treatment of atrial fibrillation.	Procedure: Catheter Ablation
Electrophysiological study group	Patients undergoing a diagnostic electrophysiological study without ablation.
Atrial flutter ablation group	Patients undergoing catheter ablation of right atrial flutter at the cavotricuspid isthmus.	Procedure: Catheter Ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Catheter Ablation	Procedure		Atrial fibrillation ablation group Atrial flutter ablation group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with short term reoccurrences of atrial fibrillation after ablation.	Holter ECGs and ECGs after atrial fibrillation ablation	3 months

Secondary Outcomes

Measure	Description	Time Frame
Change in heart rate after pulmonary vein isolation	Heart rates are recorded at admission and release from the hospital.	3 days.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with atrial fibrillation scheduled for pulmonary vein isolation with either radiofrequency of cryoballoon
patients scheduled for an electrophysiological study without ablation
patients with a catheter ablation at the cavotricuspid isthmus for the treatment of right atrial flutter

Exclusion Criteria:

patients with concurrent pulmonary vein isolation and ablation of the cavotricuspid isthmus
Acute myocardial infarction, coronary artery bypass graft surgery or open heart surgery within less than 3 months prior to inclusion

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

Patients with atrial fibrillation schedulded for pulmonary vein isolation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Meyer, Prof. Dr.	Germany Department of Cardiology - Electrophysiology, University Heart Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf		Hamburg		20246	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

Intervention Browse Module

MeSH Terms

ID	Term
D017115	Catheter Ablation

Ancestor Terms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided