Atrial FibrillationNCT05603611
Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center
An observational study of Atrial Fibrillation, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 26 Oct 2021to 30 Dec 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients presenting at Heidelberg University Hospital with an indication for AF ablation via the clinical routine.
Who may be able to join
- age ≥18 years, ability to provide informed consent and at least one episode of documented paroxysmal or persistent AF
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Heidelberg, Department of Cardiology
Heidelberg
About this study
Official title: Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center - Operator Learning Curve and Procedural Outcome Parameters
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.
Read the 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).
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationDevice
Local electrical isolation of PV ostia to prevent recurrence of AF due to ectopic PV-triggers
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure duration
Measured: Day of index procedure, number of minutes
LA dwell time
Minutes
Measured: Day of index procedure, number of minutes
Fluoroscopy duration
Minutes
Measured: Day of index procedure, number of minutes
Secondary outcomes (3)
Short-term AF arrhythmia recurrence
ECG-documented AF
Measured: 3 months
Procedural complications
As diagnosed by physician and documented in written report
Measured: 3 months
Long-term arrhythmia recurrence
ECG-documented AF
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start26 Oct 2021
- Primary completion23 Oct 2022
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Principal investigator, Maura Zylla, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603611
- Sponsor's protocol ID
- UHHeidelberg_2
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39588067
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center - Operator Learning Curve and Procedural Outcome Parameters
- ClinicalTrials.gov ID
- NCT05603611
- Acronym / sponsor ID
- UHHeidelberg_2
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 23 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients presenting at Heidelberg University Hospital with an indication for AF ablation via the clinical routine.
Key inclusion criteria (1 listed)
- age ≥18 years, ability to provide informed consent and at least one episode of documented paroxysmal or persistent AF
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary vein isolationLocal electrical isolation of PV ostia to prevent recurrence of AF due to ectopic PV-triggers | Device | – |
Primary outcome
Procedure duration
Time frame: Day of index procedure, number of minutes
LA dwell time
Time frame: Day of index procedure, number of minutes
Minutes
Fluoroscopy duration
Time frame: Day of index procedure, number of minutes
Minutes
3 secondary outcomes
Short-term AF arrhythmia recurrence
Time frame: 3 months
Procedural complications
Time frame: 3 months
Long-term arrhythmia recurrence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 39588067Zylla 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure duration (time frame: Day of index procedure, number of minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.