High Power Short Duration Ablation Compared to Moderate P... | NCT05959798

Studies
High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation

NCT05959798

Sponsor

Deutsches Herzzentrum Muenchen

Status

Completed

Last Update Posted

Jul 25, 2023Actual

Enrollment

204Actual

Phase

Not provided

Conditions

Paroxysmal Atrial Fibrillation

Interventions

High power short duration 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

Jul 2023

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 20, 2019Actual

Primary Completion Date

Jul 17, 2023Actual

Completion Date

Jul 17, 2023Actual

First Submitted Date

Jul 17, 2023

First Submission Date that Met QC Criteria

Jul 17, 2023

First Posted Date

Jul 25, 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

Jul 17, 2023

Last Update Posted Date

Jul 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: safety and acute procedural outcome

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

204Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High power short duration ablation			Procedure: High power short duration ablation
Moderate power long duration ablation			Procedure: High power short duration ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High power short duration ablation	Procedure	Pulmonary vein isolation by high power short duration radiofrequency catheter ablation	High power short duration ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of reconnected pulmonary veins 20 minutes after ablation in comparison of both ablation groups		Acute endpoint

Secondary Outcomes

Measure	Description	Time Frame
Time to first documented recurrence of atrial fibrillation after a 6-week blanking period.		12 months after ablation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

symptomatic, documented, drug-resistent paroxysmal atrial fibrillation
effective oral anticoagulation

Exclusion Criteria:

any prior left atrial ablation procedure
presence of left atrial thrombus
secondary atrial fibrillation due to electrolyte imbalance or thyroid disease
any prior oesophageal or gastric surgery

Accepts Healthy Volunteers

Not provided

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 documented paroxysmal atrial fibrillation, not previously treated by left atrial catheter ablation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabel Deisenhofer, Prof. Dr.	Deutsches Herzzentrum München, Abt. für Elektrophysiologie	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

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