QDOT Based PVI for Atrial Fibrillation Treatment - The pe... | NCT05710822

Studies
QDOT Based PVI for Atrial Fibrillation Treatment - The peQasus Study

NCT05710822

Sponsor

University of Luebeck

Status

Unknown status

Last Update Posted

Feb 2, 2023Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

pulmonary vein isolation

Countries

Not provided

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

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2023Estimated

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Jan 17, 2023

First Submission Date that Met QC Criteria

Jan 25, 2023

First Posted Date

Feb 2, 2023Actual

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

Jan 25, 2023

Last Update Posted Date

Feb 2, 2023Actual

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

PeQasus is a worldwide, retrospective, multicenter analysis focusing on QDOT based PVI. Data of at least 300 patients with QDOT based PVI will be collected. All data will be evaluated after anonymization. Primary endoints are efficacy and safety.

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

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pulmonary vein isolation	Device	pulmonary vein isolation utilizing the QDOT Micro ablation catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of the procedure	Acute PVI	Periprocedural
Saftey (Cardiac tamponade)	Periprocedural complications (occurence of cardiac tamponade)	Periprocedural
Safety (Stroke)	Periprocedural complications (occurence of stroke)	Periprocedural
Safety (Bleeding)	Periprocedural complications (occurence of puncture site bleeding)	Periprocedural

Secondary Outcomes

Measure	Description	Time Frame
Procedure time		Periprocedural
LA dwelling time		Periprocedural
First pass isolation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suitable for PVI

Exclusion Criteria:

Non suitable for PVI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Afib patients with indication to pulmonary vein isolation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian-Hendrik Heeger, MD	Contact	004945150075293		christian.heeger@gmx.net

Overall Officials

Name	Affiliation	Role
Christian-Hendrik Heeger, MD	Department of Rhythmology	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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