Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2022
CompletedFirst Submitted
Initial submission to the registry
October 26, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedNovember 2, 2022
October 1, 2022
12 months
October 26, 2022
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 (3)
Short-term AF arrhythmia recurrence
3 months
Procedural complications
3 months
Long-term arrhythmia recurrence
12 months
Interventions
Local electrical isolation of PV ostia to prevent recurrence of AF due to ectopic PV-triggers
Eligibility Criteria
Consecutive patients presenting at Heidelberg University Hospital with an indication for AF ablation via the clinical routine.
You may qualify if:
- age ≥18 years, ability to provide informed consent and at least one episode of documented paroxysmal or persistent AF
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Heidelberglead
- Biosense Webster, Inc.collaborator
Study Sites (1)
University Hospital Heidelberg, Department of Cardiology
Heidelberg, Germany
Related Publications (1)
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.
PMID: 39588067DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Principal Investigator
Study Record Dates
First Submitted
October 26, 2022
First Posted
November 2, 2022
Study Start
October 26, 2021
Primary Completion
October 23, 2022
Study Completion
December 30, 2022
Last Updated
November 2, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share