Radiofrequency Balloon Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolated and Clinical Outome

NCT06296888 | Active Not Recruiting

• 2 other identifiers: P-2022-6732203718
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  4-6 months

Secondary Outcomes (4)

• Proportion of patients with durable isolation of all PVs observed at repeat EP study

  4-6 months

• Proportion of patients remaining free from recurrence of ATA after the initial PVI

  4-6 months

• Difference in the effect of AF related symptoms on quality of life between baseline and after the initial PVI

  4-6 months

• Complications

  Occurring within 3 months after the initial PVI procedure

Other Outcomes (2)

• Proportion of patients remaining free from recurrence of ATA after the repeat EP study

  12 months

• Difference in the effect of AF related symptoms on quality of life between baseline, after the initial PVI, and after the repeat EP study

  12 months

Study Arms (1)

Radiofrequency balloon catheter ablation

EXPERIMENTAL

Enrolled patients will undergo PVI by radiofrequency balloon ablation.

Procedure: Radiofrequency balloon catheter ablation

Interventions

Radiofrequency balloon catheter ablation PROCEDURE

Radiofrequency balloon ablation using the HELIOSTAR™ ablation catheter.

Radiofrequency balloon catheter ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented AF
• Clinical indication for ablation
• First time AF ablation
• Scheduled for PVI only

You may not qualify if:

• 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

Sponsors & Collaborators

• Jim Hansen: lead
• University Hospital, Gentofte, Copenhagen: collaborator
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Gentofte Hospital

Hellerup, 2820, Denmark

Location

Related Publications (11)

• 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.

  PMID: 32860505 BACKGROUND

• Calkins 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.

  PMID: 28506916 BACKGROUND

• Andrade 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.

  PMID: 33197159 BACKGROUND

• Kuniss 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.

  PMID: 33728429 BACKGROUND

• Wazni 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.

  PMID: 33197158 BACKGROUND

• Reddy 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.

  PMID: 31826648 BACKGROUND

• Dhillon 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.

  PMID: 32250514 BACKGROUND

• Schilling 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.

  PMID: 33450010 BACKGROUND

• Sorensen 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.

  PMID: 33835823 BACKGROUND

• Worck 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.

  PMID: 35598313 BACKGROUND

• Sorensen 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.

  PMID: 40662466 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jim Hansen, MD, DMSc

  University Hospital, Gentofte, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Cardiologist, MD, DMSc

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: October 1, 2022
• Primary Completion: March 15, 2024
• Study Completion: August 9, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)