Atrial FibrillationRABAAFNCT06296888
Radiofrequency Balloon Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolated and Clinical Outome
A study testing Radiofrequency balloon catheter ablation in people with Atrial Fibrillation, run by Jim Hansen at 1 site in Denmark.
Trial summary
Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult human population. AF is a disturbance in the electrical impulses of the heart - an electrical disturbance commonly originating from the pulmonary veins. 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?
- Radiofrequency balloon catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2022to 9 Aug 2024
- 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
- Documented AF
- Clinical indication for ablation
- First time AF ablation
- Scheduled for PVI only
Who cannot join
- Contraindication for ablation
- Inability to give informed consent
- Documented atrial flutter or any other arrhythmia requiring ablation in addition to PVI
- Known esophageal or nasopharyngeal pathology that would preclude insertion of an esophageal temperature probe
- Severe asthma that would preclude adenosine injections for assessment of dormant conduction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiofrequency Balloon Catheter Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolation and Clinical Outcome - The RABAAF Study
Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult human population. AF is a disturbance in the electrical impulses of the heart - an electrical disturbance commonly originating from the pulmonary veins.
Normalization of the heart rhythm with anti-arrhythmic drugs often fail and is frequently associated with side effects. Therefore, a treatment termed ablation by catheters via an inguinal vein has been devised and is increasingly being used for the treatment of AF. The cornerstone of this treatment is electrical isolation of the pulmonary veins so that the nocuous electrical impulses from the pulmonary veins cannot cause a disturbance in the heart rhythm and initiate episodes of AF. This treatment is called pulmonary vein isolation (PVI). Recent studies have shown that PVI is better than anti-arrhythmic drug treatment in the prevention of recurrence of AF, but despite substantial improvements in techniques and tools only 60-70% are cured from AF by a single PVI procedure, and in around 80% of patients who require additional catheter ablation, durable isolation of all the pulmonary veins has not been achieved. Improved tools for durable PVI are therefore required.
Read more
A novel catheter to achieve PVI called the HELIOSTAR™ radiofrequency balloon ablation catheter has shown promising clinical results with a favorable safety profile, but the durability of PVI has not been evaluated. Therefore, we aim to investigate the long-term durability of PVI by the radiofrequency balloon and the clinical outcome following the procedure.
In this study, patients with AF referred for catheter ablation will undergo an initial PVI treatment using the radiofrequency balloon catheter. All patients will undergo a repeat electrophysiology (EP) study after 4-6 months to determine to durability of PVI. Patients will be issued with a 48-hour heart rhythm monitor at 3 and 12 months after the initial PVI. Patients-reported effects on quality of life by AF related symptoms will be evaluated using a specialized questionnaire provided approximately every third month throughout the 12 month follow-up.
Read the detailed description
The study is a single-arm prospective cohort study in 45 patients referred for AF ablation that will assess the durability of PVI, freedom from atrial tachyarrhythmia (ATA) recurrence and patient reported quality of life following PVI by radiofrequency balloon catheter ablation.
All patients, irrespective of ATA recurrence, will undergo a repeat EP study 4-6 months after initial PVI for the assessment of PVI durability. Recurrence of ATA after the initial PVI will be evaluated by 48-hour ambulatory electrocardiography (ECG) monitoring following a 3-months blanking period after the PVI procedure, and effect on quality of life will be evaluated by questionnaires at baseline, 3 months after the initial PVI, and at the time of the repeat procedure.
Recurrence of ATA after the repeat EP study will be evaluated by 48-hour ambulatory ECG monitoring 12 months after the initial PVI, and effect on quality of life will be evaluated by additional questionnaires at 9 and 12 months after the initial PVI.
In patients with symptoms of potentiel ATA outside the protocolled ambulatory ECG monitoring periods, ECG diagnostics appropriate for the duration and frequency of episodes with symptoms will be utilized.
- Conditions
- Atrial Fibrillation
- Being tested
- Radiofrequency balloon 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.
Radiofrequency balloon catheter ablationProcedure or surgery
Radiofrequency balloon ablation using the HELIOSTAR™ ablation catheter.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency balloon catheter ablation | Experimental | Enrolled patients will undergo PVI by radiofrequency balloon ablation. Receives: Procedure: Radiofrequency balloon catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of durably isolated PVs observed at repeat EP study
During repeat EP study 4-6 months after initial PVI, all PVs are assessed for bidirectional block. Any reconnected PVs will be reisolated. After confirmation of bidirectional conduction block (preceded by reisolation in case of PV reconduction), adenosine injections will be used to test for dormant conduction. PVs with dormant conduction are not considered durably isolated.
Measured: 4-6 months
Secondary outcomes (4)
Proportion of patients with durable isolation of all PVs observed at repeat EP study
During repeat EP study 4-6 months after initial PVI, all PVs are assessed for bidirectional block. Any reconnected PVs will be reisolated. After confirmation of bidirectional conduction block (preceded by reisolation in case of PV reconduction), adenosine injections will be used to test for dormant conduction. PVs with dormant conduction are not considered durably isolated.
Measured: 4-6 months
Proportion of patients remaining free from recurrence of ATA after the initial PVI
The proportion of patients that remain free from recurrence ATA (AF, atrial flutter, and/or atrial tachycardia) ≥ 30 seconds of duration following a 3 month blanking period after initial PVI, documented by any type of ECG.
Measured: 4-6 months
Difference in the effect of AF related symptoms on quality of life between baseline and after the initial PVI
The effect of AF related symptoms on quality of life assessed by the sum of units on The Atrial Fibrillation Effect on QualiTy of life survey (AFEQT) questionnaire
Measured: 4-6 months
Complications
Complications attributed to radiofrequency balloon catheter ablation
Measured: Occurring within 3 months after the initial PVI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Oct 2022
- Primary completion15 Mar 2024 (estimated)
- Study completion9 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jim Hansen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Biosense Webster, Inc.
- Responsible party
- Sponsor-investigator, Jim Hansen, University Hospital, Gentofte, Copenhagen
- Investigators
- Jim Hansen, MD, DMSc, Principal investigator, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296888
- Sponsor's protocol ID
- P-2022-673
- Other IDs
- 2203718
- Acronym
- RABAAF
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
PubMed 32860505Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.
PubMed 28506916Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.
PubMed 33197159Kuniss M, Pavlovic N, Velagic V, Hermida JS, Healey S, Arena G, Badenco N, Meyer C, Chen J, Iacopino S, Anselme F, Packer DL, Pitschner HF, Asmundis C, Willems S, Di Piazza F, Becker D, Chierchia GB; Cryo-FIRST Investigators. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace. 2021 Jul 18;23(7):1033-1041. doi: 10.1093/europace/euab029.
PubMed 33728429Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S, Niebauer M, Makati K, Halperin B, Gauri A, Morales G, Shao M, Cerkvenik J, Kaplon RE, Nissen SE; STOP AF First Trial Investigators. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):316-324. doi: 10.1056/NEJMoa2029554. Epub 2020 Nov 16.
PubMed 33197158Reddy VY, Schilling R, Grimaldi M, Horton R, Natale A, Riva S, Tondo C, Kuck KH, Neuzil P, McInnis K, Bishara M, Zhang B, Govari A, Abdelaal A, Mansour M. Pulmonary Vein Isolation With a Novel Multielectrode Radiofrequency Balloon Catheter That Allows Directionally Tailored Energy Delivery: Short-Term Outcomes From a Multicenter First-in-Human Study (RADIANCE). Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007541. doi: 10.1161/CIRCEP.119.007541. Epub 2019 Dec 12.
PubMed 31826648Dhillon GS, Honarbakhsh S, Di Monaco A, Coling AE, Lenka K, Pizzamiglio F, Hunter RJ, Horton R, Mansour M, Natale A, Reddy V, Grimaldi M, Neuzil P, Tondo C, Schilling RJ. Use of a multi-electrode radiofrequency balloon catheter to achieve pulmonary vein isolation in patients with paroxysmal atrial fibrillation: 12-Month outcomes of the RADIANCE study. J Cardiovasc Electrophysiol. 2020 Jun;31(6):1259-1269. doi: 10.1111/jce.14476. Epub 2020 Apr 23.
PubMed 32250514Schilling R, Dhillon GS, Tondo C, Riva S, Grimaldi M, Quadrini F, Neuzil P, Chierchia GB, de Asmundis C, Abdelaal A, Vanderlinden L, Tan T, Ding WY, Gupta D, Reddy VY. Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE. Europace. 2021 Jun 7;23(6):851-860. doi: 10.1093/europace/euaa382.
PubMed 33450010Sorensen SK, Johannessen A, Worck R, Hansen ML, Hansen J. Radiofrequency Versus Cryoballoon Catheter Ablation for Paroxysmal Atrial Fibrillation: Durability of Pulmonary Vein Isolation and Effect on Atrial Fibrillation Burden: The RACE-AF Randomized Controlled Trial. Circ Arrhythm Electrophysiol. 2021 May;14(5):e009573. doi: 10.1161/CIRCEP.120.009573. Epub 2021 Apr 9.
PubMed 33835823Worck R, Sorensen SK, Johannessen A, Ruwald M, Haugdal M, Hansen J. Posterior wall isolation in persistent atrial fibrillation feasibility, safety, durability, and efficacy. J Cardiovasc Electrophysiol. 2022 Aug;33(8):1667-1674. doi: 10.1111/jce.15556. Epub 2022 May 31.
PubMed 35598313Sorensen SK, Riis-Vestergaard LD, Tonnesen J, Johannessen A, Worck R, Eskesen K, Bertolo G, Mayorga M, Haugdal MA, Ruwald MH, Hansen ML, Hansen J. Durability of Pulmonary Vein Isolation With the Heliostar Radiofrequency Balloon-The Prospective RABAAF Study With Protocol-Mandated Repeat Electrophysiology Studies. J Cardiovasc Electrophysiol. 2025 Sep;36(9):2320-2329. doi: 10.1111/jce.70010. Epub 2025 Jul 15.
PubMed 40662466
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Balloon Catheter Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolation and Clinical Outcome - The RABAAF Study
- ClinicalTrials.gov ID
- NCT06296888
- Acronym / sponsor ID
- RABAAF / P-2022-673
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Jim HansenUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Biosense Webster, Inc.
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 9 Aug 2024 (estimated)
- First posted
- 6 Mar 2024 (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.
Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult human population. AF is a disturbance in the electrical impulses of the heart - an electrical disturbance commonly originating from the pulmonary veins.
Normalization of the heart rhythm with anti-arrhythmic drugs often fail and is frequently associated with side effects. Therefore, a treatment termed ablation by catheters via an inguinal vein has been devised and is increasingly being used for the treatment of AF. The cornerstone of this treatment is electrical isolation of the pulmonary veins so that the nocuous electrical impulses from the pulmonary veins cannot cause a disturbance in the heart rhythm and initiate episodes of AF. This treatment is called pulmonary vein isolation (PVI). Recent studies have shown that PVI is better than anti-arrhythmic drug treatment in the prevention of recurrence of AF, but despite substantial improvements in techniques and tools only 60-70% are cured from AF by a single PVI procedure, and in around 80% of patients who require additional catheter ablation, durable isolation of all the pulmonary veins has not been achieved. Improved tools for durable PVI are therefore required.
A novel catheter to achieve PVI called the HELIOSTAR™ radiofrequency balloon ablation catheter has shown promising clinical results with a favorable safety profile, but the durability of PVI has not been evaluated. Therefore, we aim to investigate the long-term durability of PVI by the radiofrequency balloon and the clinical outcome following the procedure.
In this study, patients with AF referred for catheter ablation will undergo an initial PVI treatment using the radiofrequency balloon catheter. All patients will undergo a repeat electrophysiology (EP) study after 4-6 months to determine to durability of PVI. Patients will be issued with a 48-hour heart rhythm monitor at 3 and 12 months after the initial PVI. Patients-reported effects on quality of life by AF related symptoms will be evaluated using a specialized questionnaire provided approximately every third month throughout the 12 month follow-up.
Detailed description
The study is a single-arm prospective cohort study in 45 patients referred for AF ablation that will assess the durability of PVI, freedom from atrial tachyarrhythmia (ATA) recurrence and patient reported quality of life following PVI by radiofrequency balloon catheter ablation.
All patients, irrespective of ATA recurrence, will undergo a repeat EP study 4-6 months after initial PVI for the assessment of PVI durability. Recurrence of ATA after the initial PVI will be evaluated by 48-hour ambulatory electrocardiography (ECG) monitoring following a 3-months blanking period after the PVI procedure, and effect on quality of life will be evaluated by questionnaires at baseline, 3 months after the initial PVI, and at the time of the repeat procedure.
Recurrence of ATA after the repeat EP study will be evaluated by 48-hour ambulatory ECG monitoring 12 months after the initial PVI, and effect on quality of life will be evaluated by additional questionnaires at 9 and 12 months after the initial PVI.
In patients with symptoms of potentiel ATA outside the protocolled ambulatory ECG monitoring periods, ECG diagnostics appropriate for the duration and frequency of episodes with symptoms will be utilized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency balloon catheter ablation | Experimental | Procedure: Radiofrequency balloon catheter ablationEnrolled patients will undergo PVI by radiofrequency balloon ablation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented AF
- Clinical indication for ablation
- First time AF ablation
- Scheduled for PVI only
Key exclusion criteria (5 listed)
- Contraindication for ablation
- Inability to give informed consent
- Documented atrial flutter or any other arrhythmia requiring ablation in addition to PVI
- Known esophageal or nasopharyngeal pathology that would preclude insertion of an esophageal temperature probe
- Severe asthma that would preclude adenosine injections for assessment of dormant conduction
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 |
|---|---|---|
| Radiofrequency balloon catheter ablationRadiofrequency balloon ablation using the HELIOSTAR™ ablation catheter. | Procedure or surgery | Radiofrequency balloon catheter ablation |
Primary outcome
Proportion of durably isolated PVs observed at repeat EP study
Time frame: 4-6 months
During repeat EP study 4-6 months after initial PVI, all PVs are assessed for bidirectional block. Any reconnected PVs will be reisolated. After confirmation of bidirectional conduction block (preceded by reisolation in case of PV reconduction), adenosine injections will be used to test for dormant conduction. PVs with dormant conduction are not considered durably isolated.
4 secondary outcomes
Proportion of patients with durable isolation of all PVs observed at repeat EP study
Time frame: 4-6 months
Proportion of patients remaining free from recurrence of ATA after the initial PVI
Time frame: 4-6 months
Difference in the effect of AF related symptoms on quality of life between baseline and after the initial PVI
Time frame: 4-6 months
Complications
Time frame: Occurring within 3 months after the initial PVI procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 32860505Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
- Background: PubMed 28506916Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.
- Background: PubMed 33197159Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.
- Background: PubMed 33728429Kuniss M, Pavlovic N, Velagic V, Hermida JS, Healey S, Arena G, Badenco N, Meyer C, Chen J, Iacopino S, Anselme F, Packer DL, Pitschner HF, Asmundis C, Willems S, Di Piazza F, Becker D, Chierchia GB; Cryo-FIRST Investigators. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace. 2021 Jul 18;23(7):1033-1041. doi: 10.1093/europace/euab029.
- Background: PubMed 33197158Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S, Niebauer M, Makati K, Halperin B, Gauri A, Morales G, Shao M, Cerkvenik J, Kaplon RE, Nissen SE; STOP AF First Trial Investigators. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):316-324. doi: 10.1056/NEJMoa2029554. Epub 2020 Nov 16.
- Background: PubMed 31826648Reddy VY, Schilling R, Grimaldi M, Horton R, Natale A, Riva S, Tondo C, Kuck KH, Neuzil P, McInnis K, Bishara M, Zhang B, Govari A, Abdelaal A, Mansour M. Pulmonary Vein Isolation With a Novel Multielectrode Radiofrequency Balloon Catheter That Allows Directionally Tailored Energy Delivery: Short-Term Outcomes From a Multicenter First-in-Human Study (RADIANCE). Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007541. doi: 10.1161/CIRCEP.119.007541. Epub 2019 Dec 12.
- Background: PubMed 32250514Dhillon GS, Honarbakhsh S, Di Monaco A, Coling AE, Lenka K, Pizzamiglio F, Hunter RJ, Horton R, Mansour M, Natale A, Reddy V, Grimaldi M, Neuzil P, Tondo C, Schilling RJ. Use of a multi-electrode radiofrequency balloon catheter to achieve pulmonary vein isolation in patients with paroxysmal atrial fibrillation: 12-Month outcomes of the RADIANCE study. J Cardiovasc Electrophysiol. 2020 Jun;31(6):1259-1269. doi: 10.1111/jce.14476. Epub 2020 Apr 23.
- Background: PubMed 33450010Schilling R, Dhillon GS, Tondo C, Riva S, Grimaldi M, Quadrini F, Neuzil P, Chierchia GB, de Asmundis C, Abdelaal A, Vanderlinden L, Tan T, Ding WY, Gupta D, Reddy VY. Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE. Europace. 2021 Jun 7;23(6):851-860. doi: 10.1093/europace/euaa382.
- Background: PubMed 33835823Sorensen SK, Johannessen A, Worck R, Hansen ML, Hansen J. Radiofrequency Versus Cryoballoon Catheter Ablation for Paroxysmal Atrial Fibrillation: Durability of Pulmonary Vein Isolation and Effect on Atrial Fibrillation Burden: The RACE-AF Randomized Controlled Trial. Circ Arrhythm Electrophysiol. 2021 May;14(5):e009573. doi: 10.1161/CIRCEP.120.009573. Epub 2021 Apr 9.
- Background: PubMed 35598313Worck R, Sorensen SK, Johannessen A, Ruwald M, Haugdal M, Hansen J. Posterior wall isolation in persistent atrial fibrillation feasibility, safety, durability, and efficacy. J Cardiovasc Electrophysiol. 2022 Aug;33(8):1667-1674. doi: 10.1111/jce.15556. Epub 2022 May 31.
- Derived from this study: PubMed 40662466Sorensen SK, Riis-Vestergaard LD, Tonnesen J, Johannessen A, Worck R, Eskesen K, Bertolo G, Mayorga M, Haugdal MA, Ruwald MH, Hansen ML, Hansen J. Durability of Pulmonary Vein Isolation With the Heliostar Radiofrequency Balloon-The Prospective RABAAF Study With Protocol-Mandated Repeat Electrophysiology Studies. J Cardiovasc Electrophysiol. 2025 Sep;36(9):2320-2329. doi: 10.1111/jce.70010. Epub 2025 Jul 15.
- 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.
Jim Hansen, MD, DMSc principal investigator
University Hospital, Gentofte, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency balloon catheter ablation in people with Atrial Fibrillation, run by Jim Hansen at 1 site in Denmark.
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 5 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 6 Mar 2024. 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 Denmark. 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?
Proportion of durably isolated PVs observed at repeat EP study (time frame: 4-6 months). 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 NCT06296888, which also lists 11 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 6 Mar 2024.