HIgh Power Short Duration Radiofrequency Ablation or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation

NCT04855890 | Unknown

• 1 other identifier: HIPAF-21
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary vein isolation (PVI) using the cryoballoon has been proven equal to RF-PVI and is widely used. High Power Short Duration Ablation in RF-PVI has been successfully tested in several trials. Prospective data comparing both strategies is lacking. This trial will compare acute success rates, safety and foremost long-term outcome of two different PVI strategies (HPSD-PVI vs. cryo-PVI).

Conditions

Atrial Fibrillation and Flutter; Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Keywords

atrial fibrillation; high power short duration; pulmonary vein isolation; cryo-ablation

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial arrhythmia

  Combined primary endpoint of recurrent atrial arrhythmia, onset of new AAD or re- ablation of atrial arrhythmia during the follow-up of 12 months after a 3-months blanking period.

  12 months after a 3 months blanking period

Secondary Outcomes (4)

• Periprocedural complications

  Within 48 hours of procedure

• Number of re-hospitalisations

  12 months after a 3 months blanking period

• Cardioversions

  12 months after a 3 months blanking period

• Procedural data

  During the procedure

Study Arms (2)

Cryo-Ablation

ACTIVE COMPARATOR

Cryo-Balloon (Arctic Front Advance ProTM, Medtronic, Minneapolis, MN, USA) will be advanced to the LA and navigated to the PV's using an inner-lumen circular mapping catheter (Achieve AdvanceTM, Medtronic, Minneapolis, MN, USA). After confirming complete PV sealing by the CB using occlusion angiograms cryothermal energy will be applied for min 120 seconds aiming at PV isolation of all PV's according to the clinical standard.

Procedure: Ablation

High Power Short Duration-Ablation

ACTIVE COMPARATOR

A detailed electroanatomical map of the left atrium during sinus rhythm will be acquired using Ensite (Abbott, St. Paul, MN, USA). Upon completion of the LA map, a second transseptal puncture will be performed in order to insert an ablation catheter. To achieve antral PVI irrigated radiofrequency current ablation will be performed using a power of 70W and a flush rate of 8-30ml/min with a duration of 5 seconds for the anterior and 7 seconds for the posterior LA. Ablation catheters used will contain Flexibilty (Abbott, St. Paul, MN, USA) and TactiFlex (Abbott, St. Paul, MN, USA).

Procedure: Ablation

Interventions

Ablation PROCEDURE

The ablation procedure will be performed during deep sedation using midazolam, fentanyl and a continuous infusion of propofol. Vital parameters will be monitored. For catheter access three 8F sheaths will be inserted into the femoral veins. A multipolar diagnostic catheter will be placed in the coronary sinus. Single transseptal puncture and insertion of a 8.5 F transseptal sheath or 12F Cryo-Sheath (FlexCath AdvanceTM, Medtronic, Minneapolis, MN, USA) will be followed by PV angiographies. Before or shortly after transseptal puncture unfractionated heparin will be repeatedly administered to maintain an activated clotting time between 250 and 400s.

Cryo-Ablation; High Power Short Duration-Ablation

Eligibility Criteria

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

You may qualify if:

• Symptomatic non-valvular atrial fibrillation with no prior ablation with an indication for re-ablation according to current guidelines.
• Age 18-85 years.
• Patient is able to provide informed consent and is willing to comply with the study protocol.

You may not qualify if:

• Contraindications for left atrial ablation
• History of interventional or surgical AF-ablation
• History of stroke during the past 12 months
• BMI \>40kg/m2
• History of mitral valve surgery
• Severe mitral valve regurgitation
• Inability to be treated with oral anticoagulation
• Presence of intracardiac thrombi
• Contraindication or absolute indication for one of the two strategies
• Pregnancy
• Participation in other clinical studies
• Unwilling to follow the study protocol and to attend follow-up visits

Sponsors & Collaborators

• Universitätsklinikum Köln: lead

Study Sites (1)

Department of electrophysiology, Heart Center Cologne, University of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Related Publications (4)

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

  PMID: 27567408 BACKGROUND

• Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

  PMID: 27042964 BACKGROUND

• Murray MI, Arnold A, Younis M, Varghese S, Zeiher AM. Cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation: a meta-analysis of randomized controlled trials. Clin Res Cardiol. 2018 Aug;107(8):658-669. doi: 10.1007/s00392-018-1232-4. Epub 2018 Mar 21.

  PMID: 29564527 BACKGROUND

• Kottmaier M, Popa M, Bourier F, Reents T, Cifuentes J, Semmler V, Telishevska M, Otgonbayar U, Koch-Buttner K, Lennerz C, Bartkowiak M, Kornmayer M, Rousseva E, Brkic A, Grebmer C, Kolb C, Hessling G, Deisenhofer I. Safety and outcome of very high-power short-duration ablation using 70 W for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. Europace. 2020 Mar 1;22(3):388-393. doi: 10.1093/europace/euz342.

  PMID: 31872249 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Arian Sultan, PD Dr.

  University of Cologne, Heart Center, Dept. of Electrophysiology

  PRINCIPAL INVESTIGATOR

• Daniel Steven, Prof. Dr.

  University of Cologne, Heart Center, Dept. of Electrophysiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Wörmann

CONTACT

+4917699992357; jonas.woermann@uk-koeln.de

Arian Sultan, PD Dr.

CONTACT

+4922147832396; arian.sultan@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The present study is a mono-center prospective randomized study enrolling 170 patients with PAF and no prior Ablation for AF. Patients will be randomized to one of the following groups. Group A: Cryo-Ablation PVI will be performed using a Cryo-balloon. Group B: High-Power-Short-Duration PVI will be performed using HPSD RF-ablation. (70W over 5s posterior and 7s anterior) Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (EnSite, Abbott) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance Pro, Medtronic).

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)