Implementation of the HELIOSTARTM in Real-world Clinical... | NCT05603611

Studies
Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center

NCT05603611

Sponsor

University Hospital Heidelberg

Status

Unknown status

Last Update Posted

Nov 2, 2022Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 26, 2021Actual

Primary Completion Date

Oct 23, 2022Actual

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Oct 26, 2022

First Submission Date that Met QC Criteria

Oct 31, 2022

First Posted Date

Nov 2, 2022Actual

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

Oct 31, 2022

Last Update Posted Date

Nov 2, 2022Actual

Name	Class
Biosense Webster, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The HELIOSTARTM catheter (Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF), combining radiofrequency (RF)-ablation and 3D-mapping visualization with the concept of "single-shot"-ablation device. This study evaluates the operator learning curve und procedural outcome during implementation of the HELIOSTARTM.

Detailed Description

The first patients undergoing PVI by HELIOSTARTM at Heidelberg University Hospital are included in this prospective study. Procedures are performed by an operator proficient in CB-ablation. Procedural outcome was analyzed over the course of increasing experience with the device and in comparison to a previous cohort investigated during implementation of the Arctic FrontTM-cryoballoon (Medtronic).

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

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary vein isolation	Device	Local electrical isolation of PV ostia to prevent recurrence of AF due to ectopic PV-triggers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procedure duration		Day of index procedure, number of minutes
LA dwell time	Minutes	Day of index procedure, number of minutes
Fluoroscopy duration	Minutes	Day of index procedure, number of minutes

Secondary Outcomes

Measure	Description	Time Frame
Short-term AF arrhythmia recurrence	ECG-documented AF	3 months
Procedural complications	As diagnosed by physician and documented in written report

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥18 years, ability to provide informed consent and at least one episode of documented paroxysmal or persistent AF

Exclusion Criteria:

history of prior AF ablation, left atrial thrombus, suspected irregular PV-anatomy in pre-procedural transesophageal echocardiography (TOE) or contraindication for peri-procedural anticoagulation therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients presenting at Heidelberg University Hospital with an indication for AF ablation via the clinical routine.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Heidelberg, Department of Cardiology		Heidelberg			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39588067	Derived	Zylla MM, Leiner J, Rahm AK, Hoffmann T, Lugenbiel P, Schweizer P, Mages C, Mereles D, Kieser M, Scholz E, Katus HA, Frey N, Thomas D. Catheter ablation of atrial fibrillation in women with heart failure with preserved ejection fraction. Front Cardiovasc Med. 2024 Nov 11;11:1463815. doi: 10.3389/fcvm.2024.1463815. eCollection 2024.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes