Atrial FibrillationHARTCAP-AFNCT02441738
Hybrid Versus Catheter Ablation in Persistent AF
A study testing Hybrid Ablation and Catheter Ablation in people with Atrial Fibrillation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains the most feared complication of AF with an increase in risk by 5-fold. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Hybrid Ablation and Catheter Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Oct 2016to 31 Dec 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Known with a history of symptomatic persistent AF or longstanding persistent atrial fibrillation,
- Refractory to or intolerant of at least one antiarrhythmic drug class I or III,
- At least 18 years of age,
- Mentally able and willing to give informed consent.
Who cannot join
- Previous ablation procedure,
- Longstanding persistent AF > 3 years,
- Paroxysmal atrial fibrillation. Successful cardioversion within 48 hours of onset of the arrhythmia will be also considered paroxysmal. In patients with paroxysmal and persistent AF, the dominant pattern should be taken to categorize,
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause,
- Presence of left atrial appendage (LAA) thrombus,
- Left atrial size ≥ 60mm (PLAX-view on TEE),
Show all 28Show fewer
- Left ventricular ejection fraction < 40%,
- In need for other cardiac surgery then AF treatment within 12 months,
- Intolerance to heparin and warfarin,
- Unable to undergo TEE,
- Sick-sinus-syndrome
- Mitral valve insufficiency > Iº
- Carotic stenosis > 80%,
- Active infection or sepsis,
- Pleural adhesions,
- Elevated hemi diaphragm
- Significant pulmonary dysfunction as assessed by preoperative lung testing,
- Chronic obstructive pulmonary disease with a FEV1 or VC < 50% predicted
- History of cerebrovascular accident (CVA) or transient ischemic attack (TIA),
- History of blood clotting abnormalities,
- History of thoracic radiation,
- History of pericarditis,
- History of cardiac tamponade,
- History of thoracotomy or cardiac surgery,
- Body-mass-index > 40,
- Pregnancy,
- Life expectancy less than 12 months,
- Participation in any other clinical study involving an investigational drug or device.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229HX
About this study
Official title: Hybrid Thoracoscopic Surgical and Transvenous Catheter Ablation Versus Transvenous Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains the most feared complication of AF with an increase in risk by 5-fold.
Catheter ablation has evolved as a standardized treatment option in paroxysmal AF. Due to the advanced electrical and structural remodeling the single procedural results of catheter ablation for persistent and longstanding persistent AF are rather disappointing without a proven superiority of any applied strategy compared to others. However, repeated catheter ablation can achieve better results. The surgical (epicardial) approach seems to be more effective, though still a significant amount of failures exist. Checking the epicardial ablation lines and if necessary making additional endocardial lines (which is a hybrid ablation) is expected to be most efficacious in avoiding lesion gaps and providing the most complete lesion set.
The study objective of this pilot trial is to compare the safety and efficacy of catheter ablation within 6 months versus a hybrid ablation consisting of endoscopic epicardial surgery combined with endocardial catheter ablation (performed one-stage) in preventing the recurrence of atrial fibrillation (AF) in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Hybrid Ablation, Catheter Ablation
- Keywords
- Atrial Fibrillation, Hybrid Ablation, Catheter 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.
Hybrid AblationProcedure or surgery
The procedure will be performed following standard of care guidelines.
Catheter AblationProcedure or surgery
The procedure will be performed following standard of care guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Ablation | Active comparator | Epicardial surgical ablation performed thoracoscopically with occlusion/removal of the LAA combined with percutaneous endocardial ablation (one-stage). Receives: Procedure: Hybrid Ablation |
| Catheter Ablation | Active comparator | Percutaneous endocardial catheter ablation, with optional repeated catheter ablation(s). Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from any AT off antiarrhythmic drugs class I or III lasting > 5 minutes after the blanking period, evaluated by any ECG-tracing and 7-day holter.
Measured: 12 Months
Major complications during follow-up
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 posted12 May 2015 (estimated)
- Study start31 Oct 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Pison, MD, PhD, Principal investigator, Maastricht University Medical CenterMark La Meir, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441738
- Sponsor's protocol ID
- NL.52951.068.16
- Acronym
- HARTCAP-AF
- Status last verified
- May 2019
- First submitted
- 4 May 2015
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Heijden CAJ, Weberndorfer V, Vroomen M, Luermans JG, Chaldoupi SM, Bidar E, Vernooy K, Maessen JG, Pison L, van Kuijk SMJ, La Meir M, Crijns HJGM, Maesen B. Hybrid Ablation Versus Repeated Catheter Ablation in Persistent Atrial Fibrillation: A Randomized Controlled Trial. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1013-1023. doi: 10.1016/j.jacep.2022.12.011. Epub 2023 Jan 18.
PubMed 36752455Vroomen M, La Meir M, Maesen B, Luermans JGL, Vernooy K, Essers B, de Greef BTA, Maessen JG, Crijns HJ, Pison L. Hybrid thoracoscopic surgical and transvenous catheter ablation versus transvenous catheter ablation in persistent and longstanding persistent atrial fibrillation (HARTCAP-AF): study protocol for a randomized trial. Trials. 2019 Jun 20;20(1):370. doi: 10.1186/s13063-019-3365-9.
PubMed 31221218
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Thoracoscopic Surgical and Transvenous Catheter Ablation Versus Transvenous Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02441738
- Acronym / sponsor ID
- HARTCAP-AF / NL.52951.068.16
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Hybrid Ablation, Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 May 2015 (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.
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains the most feared complication of AF with an increase in risk by 5-fold.
Catheter ablation has evolved as a standardized treatment option in paroxysmal AF. Due to the advanced electrical and structural remodeling the single procedural results of catheter ablation for persistent and longstanding persistent AF are rather disappointing without a proven superiority of any applied strategy compared to others. However, repeated catheter ablation can achieve better results. The surgical (epicardial) approach seems to be more effective, though still a significant amount of failures exist. Checking the epicardial ablation lines and if necessary making additional endocardial lines (which is a hybrid ablation) is expected to be most efficacious in avoiding lesion gaps and providing the most complete lesion set.
The study objective of this pilot trial is to compare the safety and efficacy of catheter ablation within 6 months versus a hybrid ablation consisting of endoscopic epicardial surgery combined with endocardial catheter ablation (performed one-stage) in preventing the recurrence of atrial fibrillation (AF) in symptomatic, drug refractory patients with persistent or longstanding 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 |
|---|---|---|
| Hybrid Ablation | Active comparator | Procedure: Hybrid AblationEpicardial surgical ablation performed thoracoscopically with occlusion/removal of the LAA combined with percutaneous endocardial ablation (one-stage). |
| Catheter Ablation | Active comparator | Procedure: Catheter AblationPercutaneous endocardial catheter ablation, with optional repeated catheter ablation(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Known with a history of symptomatic persistent AF or longstanding persistent atrial fibrillation,
- Refractory to or intolerant of at least one antiarrhythmic drug class I or III,
- At least 18 years of age,
- Mentally able and willing to give informed consent.
Key exclusion criteria (28 listed)
- Previous ablation procedure,
- Longstanding persistent AF > 3 years,
- Paroxysmal atrial fibrillation. Successful cardioversion within 48 hours of onset of the arrhythmia will be also considered paroxysmal. In patients with paroxysmal and persistent AF, the dominant pattern should be taken to categorize,
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause,
- Presence of left atrial appendage (LAA) thrombus,
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 |
|---|---|---|
| Hybrid AblationThe procedure will be performed following standard of care guidelines. | Procedure or surgery | Hybrid Ablation |
| Catheter AblationThe procedure will be performed following standard of care guidelines. | Procedure or surgery | Catheter Ablation |
Primary outcome
Freedom from any AT off antiarrhythmic drugs class I or III lasting > 5 minutes after the blanking period, evaluated by any ECG-tracing and 7-day holter.
Time frame: 12 Months
Major complications during follow-up
Time frame: 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 16 May 2019.
- Derived from this study: PubMed 36752455van der Heijden CAJ, Weberndorfer V, Vroomen M, Luermans JG, Chaldoupi SM, Bidar E, Vernooy K, Maessen JG, Pison L, van Kuijk SMJ, La Meir M, Crijns HJGM, Maesen B. Hybrid Ablation Versus Repeated Catheter Ablation in Persistent Atrial Fibrillation: A Randomized Controlled Trial. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1013-1023. doi: 10.1016/j.jacep.2022.12.011. Epub 2023 Jan 18.
- Derived from this study: PubMed 31221218Vroomen M, La Meir M, Maesen B, Luermans JGL, Vernooy K, Essers B, de Greef BTA, Maessen JG, Crijns HJ, Pison L. Hybrid thoracoscopic surgical and transvenous catheter ablation versus transvenous catheter ablation in persistent and longstanding persistent atrial fibrillation (HARTCAP-AF): study protocol for a randomized trial. Trials. 2019 Jun 20;20(1):370. doi: 10.1186/s13063-019-3365-9.
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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.
Laurent Pison, MD, PhD principal investigator
Maastricht University Medical Center
Mark La Meir, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Ablation and Catheter Ablation in people with Atrial Fibrillation, run by Maastricht University Medical Center at 1 site in Netherlands.
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 28 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 16 May 2019. 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 Netherlands. 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?
Freedom from any AT off antiarrhythmic drugs class I or III lasting > 5 minutes after the blanking period, evaluated by any ECG-tracing and 7-day holter. (time frame: 12 Months). The study lists 2 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 NCT02441738, which also lists 2 linked publications.
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 16 May 2019.