Persistent Atrial FibrillationNCT01863472
Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
A study testing HeartLight(TM) Laser Balloon and irrigated radiofrequency current ablation in people with Persistent Atrial Fibrillation, run by Boris Schmidt at 6 sites in 3 countries.
Trial summary
Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- HeartLight(TM) Laser Balloon and irrigated radiofrequency current ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jun 2013to Nov 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years
- persistent atrial fibrillation
- failure of at least one antiarrhythmic drug
- others
Who cannot join
- contraindications for pulmonary vein isolation (PVI)
- previous PVI attempts
- inability to be treated with oral anticoagulation
- presence of intracardiac thrombi
- pregnancy
- others
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany4 sites
Herz- und Gefäß-Klinik GmbH Bad Neustadt
Bad Neustadt an der Saale, Bavaria, 97616
Rheinische Friedrich-Wilhelms-Universität Bonn
Bonn, North Rhine-Westphalia, 53105
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, 60431
Städtisches Klinikum Karlsruhe, Medizinische Klinik IV
Karlsruhe, 76133
About this study
Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- HeartLight(TM) Laser Balloon, irrigated radiofrequency current ablation
- 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(TM) Laser BalloonDevice
With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided
irrigated radiofrequency current ablationDevice
The irrigated radiofrequency current ablation is used for pulmonary vein isolation
| Study group | Role | What they receive |
|---|---|---|
| HeartLight(TM) Laser Balloon | Active comparator | Safety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation) Receives: Device: HeartLight(TM) Laser Balloon |
| irrigated radiofrequency current ablation | Active comparator | Safety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation Receives: Device: irrigated radiofrequency current ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds
Measured: between day 90 and 365 days after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2016
- Study completionNov 2016
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 Persistent 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boris Schmidt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Boris Schmidt, Cardioangiologisches Centrum Bethanien
- Investigators
- Boris Schmidt, Dr., Principal investigator, Cardioangiologisches Centrum Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863472
- Sponsor's protocol ID
- FF20/13 Version 03
- Status last verified
- Nov 2016
- First submitted
- 19 May 2013
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt B, Neuzil P, Luik A, Osca Asensi J, Schrickel JW, Deneke T, Bordignon S, Petru J, Merkel M, Sediva L, Klostermann A, Perrotta L, Cano O, Chun KRJ. Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study. Circ Arrhythm Electrophysiol. 2017 Dec;10(12):e005767. doi: 10.1161/CIRCEP.117.005767.
PubMed 29217521
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
- ClinicalTrials.gov ID
- NCT01863472
- Acronym / sponsor ID
- FF20/13 Version 03
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Boris SchmidtUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 May 2013 (estimated)
- 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.
Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartLight(TM) Laser Balloon | Active comparator | Device: HeartLight(TM) Laser BalloonSafety and efficacy of pulmonary vein isolation using the HeartLight(TM) Laser Balloon (endoscopically guided ablation) |
| irrigated radiofrequency current ablation | Active comparator | Device: irrigated radiofrequency current ablationSafety and efficacy of pulmonary vein isolation using the irrigated radiofrequency current ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 80 years
- persistent atrial fibrillation
- failure of at least one antiarrhythmic drug
- others
Key exclusion criteria (6 listed)
- contraindications for pulmonary vein isolation (PVI)
- previous PVI attempts
- inability to be treated with oral anticoagulation
- presence of intracardiac thrombi
- pregnancy
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(TM) Laser BalloonWith the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided | Device | HeartLight(TM) Laser Balloon |
| irrigated radiofrequency current ablationThe irrigated radiofrequency current ablation is used for pulmonary vein isolation | Device | irrigated radiofrequency current ablation |
Primary outcome
Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds
Time frame: between day 90 and 365 days after index procedure
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 21 Nov 2016.
- Derived from this study: PubMed 29217521Schmidt B, Neuzil P, Luik A, Osca Asensi J, Schrickel JW, Deneke T, Bordignon S, Petru J, Merkel M, Sediva L, Klostermann A, Perrotta L, Cano O, Chun KRJ. Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study. Circ Arrhythm Electrophysiol. 2017 Dec;10(12):e005767. doi: 10.1161/CIRCEP.117.005767.
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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.
Boris Schmidt, Dr. principal investigator
Cardioangiologisches Centrum Bethanien
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartLight(TM) Laser Balloon and irrigated radiofrequency current ablation in people with Persistent Atrial Fibrillation, run by Boris Schmidt at 6 sites in 3 countries.
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 4 inclusion and 6 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Czechia, Spain. 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?
Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds (time frame: between day 90 and 365 days after 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 NCT01863472, 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 21 Nov 2016.