Atrial FibrillationNCT03470636
Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon
A study testing HeartLight X3 in people with Atrial Fibrillation, run by CardioFocus at 1 site in Czechia.
Trial summary
The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- HeartLight X3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Feb 2018to 16 Jan 2020
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- paroxysmal atrial fibrillation failure of at least one AAD others
Who cannot join
- overall good health as established by multiple criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of the HeartLight X3 Endoscopic Ablation System (EAS) With Excalibur Balloon Compared to HeartLight System in the Treatment of Symptomatic Atrial Fibrillation
The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- HeartLight X3
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartLight X3Device
Pulmonary vein isolation
| Study group | Role | What they receive |
|---|---|---|
| HeartLight X3 | Experimental | Pulmonary vein isolation using HeartLight X3 Receives: Device: HeartLight X3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ablation time
Ablation time
Measured: Acute - at the end of the index procedure
Secondary outcomes (4)
Procedure time
Procedure time
Measured: Acute - at the end of the index procedure
PV Isolation
Percent of isolated pulmonary veins
Measured: Acute - at the end of the index procedure
PAE Rate
Primary Adverse Event rate
Measured: 30 Days
AF Free Rate
6- and 12-month chronic results
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start15 Feb 2018
- Primary completion15 Nov 2018
- Study completion16 Jan 2020
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioFocus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Burke T. Barrett, Study director, CardioFocus, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470636
- Sponsor's protocol ID
- 25-4378
- Status last verified
- Feb 2021
- First submitted
- 6 Mar 2018
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmidt B, Petru J, Chun KRJ, Sediva L, Bordignon S, Chen S, Neuzil P. Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System. Circ Arrhythm Electrophysiol. 2021 Mar;14(3):e009544. doi: 10.1161/CIRCEP.120.009544. Epub 2021 Feb 11.
PubMed 33570423
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the HeartLight X3 Endoscopic Ablation System (EAS) With Excalibur Balloon Compared to HeartLight System in the Treatment of Symptomatic Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03470636
- Acronym / sponsor ID
- 25-4378
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CardioFocusIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 20 Mar 2018 (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 objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartLight X3 | Experimental | Device: HeartLight X3Pulmonary vein isolation using HeartLight X3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- paroxysmal atrial fibrillation failure of at least one AAD others
Key exclusion criteria (1 listed)
- overall good health as established by multiple criteria
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 |
|---|---|---|
| HeartLight X3Pulmonary vein isolation | Device | HeartLight X3 |
Primary outcome
Ablation time
Time frame: Acute - at the end of the index procedure
Ablation time
4 secondary outcomes
Procedure time
Time frame: Acute - at the end of the index procedure
PV Isolation
Time frame: Acute - at the end of the index procedure
PAE Rate
Time frame: 30 Days
AF Free Rate
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Derived from this study: PubMed 33570423Schmidt B, Petru J, Chun KRJ, Sediva L, Bordignon S, Chen S, Neuzil P. Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System. Circ Arrhythm Electrophysiol. 2021 Mar;14(3):e009544. doi: 10.1161/CIRCEP.120.009544. Epub 2021 Feb 11.
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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.
Burke T. Barrett study director
CardioFocus, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartLight X3 in people with Atrial Fibrillation, run by CardioFocus at 1 site in Czechia.
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: finished, as of the sponsor's last update on 8 Feb 2021. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ablation time (time frame: Acute - at the end of the index procedure). 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 NCT03470636, 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 8 Feb 2021.