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

Sponsor

University Hospital Heidelberg (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05603611

Collaborator

Biosense Webster, Inc. (Industry)

Enrollment

Location

14.1

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Pulmonary vein isolation

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).

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center - Operator Learning Curve and Procedural Outcome Parameters

Actual Study Start Date :

Oct 26, 2021

Actual Primary Completion Date :

Oct 23, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Outcome Measures

Primary Outcome Measures

Procedure duration [Day of index procedure, number of minutes]
LA dwell time [Day of index procedure, number of minutes]
Minutes
Fluoroscopy duration [Day of index procedure, number of minutes]
Minutes

Secondary Outcome Measures

Short-term AF arrhythmia recurrence [3 months]
ECG-documented AF
Procedural complications [3 months]
As diagnosed by physician and documented in written report
Long-term arrhythmia recurrence [12 months]
ECG-documented AF

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Heidelberg, Department of Cardiology	Heidelberg		Germany

Sponsors and Collaborators

University Hospital Heidelberg
Biosense Webster, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maura Zylla, Co-Principal Investigator, University Hospital Heidelberg

ClinicalTrials.gov Identifier:

NCT05603611

Other Study ID Numbers:

UHHeidelberg_2

First Posted:

Nov 2, 2022

Last Update Posted:

Nov 2, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Nov 2, 2022