Bipolar Radio-frequency Ablation After Standard Unipolar Approach - Prospective Registry.

NCT05707637 | Recruiting DMC

• 1 other identifier: 123/2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of ventricular arrhythmias (VA) originating at the base of the heart may be challenging. Unipolar radio-frequency (RF) ablation is a standard approach to treat VA, however, it fails in 10 to 75% of patients, depending on the localization of VA. The main reason for unipolar ablation failure is the intramural location of the source of VA. In such patients, bipolar ablation may occur effective. However, there are no prospective studies or registries on consecutive patients wilt failed unipolar ablation, therefore, the proportion of candidates for bipolar ablation after failed unipolar approach is not known. Also, invasive electrophysiological parameters associated with successful unipolar and bipolar ablation have not been well established. It has been hypothesised that (1) bipolar ablation fails in 12-75% (mean 30%) of consecutive patients and these patients are candidates for bipolar ablation, (2) local ventricular signal precocity \> 20 ms, unipolar signal without R wave and pace mapping 12/12 predict effective unipolar ablation but not bipolar ablation, (3) morphology of VA from surface ECG can identify patients with possible intramural localization, and (4) successful ablation results in improvement of quality of life (QoL). Aims:

1. 1.To assess how many patients after failed unipolar ablation need redo procedure with bipolar ablation (primary end-point)
2. 2.To assess which intraprocedural electrophysiological parameters predict success during standard unipolar ablation (secondary endpoint)
3. 3.To assess short term efficacy of bipolar ablation (secondary endpoint)
4. 4.To assess one-month efficacy of bipolar ablation (secondary endpoint)
5. 5.To assess which intraprocedural electrophysiological parameters predict success during redo bipolar ablation (secondary endpoint)
6. 6.To evaluate the performance of ECG-based algorithms in predicting the localization / origin of VA, especially of transmural origin (secondary endpoint)
7. 7.To assess the effects of ablation on QoL (secondary endpoint)Methods. The study group consists of all consecutive patients who underwent unipolar ablation of VA originating from the base of the heart in the Grochowski Hospital and collaborating centres. All these patients are referred to Grochowski Hospital for further follow-up and treatment if needed, including bipolar ablation if initial unipolar approach failed. In all patients acute and one-month efficacy of unipolar and bipolar ablation is assessed.

Conditions

Ventricular Arrythmia

Keywords

ventricular arrhythmia; unipolar ablation; bipolar ablation; base of the heart

Outcome Measures

Primary Outcomes (1)

• Candidates for redo bipolar ablation

  The number and percentage of patients after failed unipolar ablation who need redo procedure with bipolar ablation

  2 years

Secondary Outcomes (10)

• Precosity of signal predicting unipolar ablation success

  2 years

• Unipolar recording predicting unipolar ablation success

  2 years

• Pace-mapping predicting success of unipolar ablation

  2 years

• Acute efficacy of bipolar ablation

  2 years

• Mid-term efficacy of bipolar ablation

  2 years

Study Arms (1)

VA group

Consecutive patients with VA originating from the base of the heart undergoing unipolar ablation

Other: Ablation

Interventions

Ablation OTHER

Unipolar and bipolar ablation

VA group

Eligibility Criteria

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

Study Population

Consecutive patients with ventricular arrhythmias originating from the base of the heart undergoing first standard unipolar ablation

You may qualify if:

• Baseline Holter ECG before initial unipolar ablation within 6 months prior to the procedure, performed without antiarrhythmic drugs (beta-blockers allowed).
• Initial unipolar ablation of VA originating from the base of the heart (R in II, III and aVF) performed according to the standard scheme which includes detailed measurements of EP parameters at each examined and/or ablated site and inspection of all three regions (RVOT with PA, GCV and LVOT/AoCusps/AMC/MA) in cases with unsatisfactory EP parameters or failed ablation at first or second site.
• Typical indications for ablation: a. \> 10 000 PVC in 24-hour Holter ECG or b. \> 10% PVC in 24-hour Holter ECG or c. less frequent but symptomatic PVC or d. at least 3 episodes symptomatic non-sustained ventricular tachycardia (nsVT) (\>3 QRS evolutions) in Holter ECG, regardless of the amount of PVC or e. sustained ventricular tachycardia (sVT), regardless of nsVT or PVC
• Written informed consent

You may not qualify if:

• History of \> 1 unipolar ablation for VA originating at the base of the heart
• Lack of properly acquired EP parameters during baseline unipolar ablation
• Lack of baseline Holter ECG performed \< 6 months prior to initial unipolar ablation
• Absence of typical indication for ablation
• Lack of written informed consent for participation in the study

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, 04-073, Poland

RECRUITING

Related Publications (11)

• Stec S, Sikorska A, Zaborska B, Krynski T, Szymot J, Kulakowski P. Benign symptomatic premature ventricular complexes: short- and long-term efficacy of antiarrhythmic drugs and radiofrequency ablation. Kardiol Pol. 2012;70(4):351-8.

  PMID: 22528707 RESULT

• Yamada T, Yoshida N, Doppalapudi H, Litovsky SH, McElderry HT, Kay GN. Efficacy of an Anatomical Approach in Radiofrequency Catheter Ablation of Idiopathic Ventricular Arrhythmias Originating From the Left Ventricular Outflow Tract. Circ Arrhythm Electrophysiol. 2017 May;10(5):e004959. doi: 10.1161/CIRCEP.116.004959.

  PMID: 28500177 RESULT

• Neira V, Santangeli P, Futyma P, Sapp J, Valderrabano M, Garcia F, Enriquez A. Ablation strategies for intramural ventricular arrhythmias. Heart Rhythm. 2020 Jul;17(7):1176-1184. doi: 10.1016/j.hrthm.2020.02.010. Epub 2020 Feb 20.

  PMID: 32087355 RESULT

• Koruth JS, Dukkipati S, Miller MA, Neuzil P, d'Avila A, Reddy VY. Bipolar irrigated radiofrequency ablation: a therapeutic option for refractory intramural atrial and ventricular tachycardia circuits. Heart Rhythm. 2012 Dec;9(12):1932-41. doi: 10.1016/j.hrthm.2012.08.001. Epub 2012 Aug 2.

  PMID: 22863684 RESULT

• Sauer PJ, Kunkel MJ, Nguyen DT, Davies A, Lane C, Tzou WS. Successful ablation of ventricular tachycardia arising from a midmyocardial septal outflow tract site utilizing a simplified bipolar ablation setup. HeartRhythm Case Rep. 2018 Nov 20;5(2):105-108. doi: 10.1016/j.hrcr.2018.11.002. eCollection 2019 Feb. No abstract available.

  PMID: 30820408 RESULT

• Futyma P, Santangeli P, Purerfellner H, Pothineni NV, Gluszczyk R, Ciapala K, Moroka K, Martinek M, Futyma M, Marchlinski FE, Kulakowski P. Anatomic approach with bipolar ablation between the left pulmonic cusp and left ventricular outflow tract for left ventricular summit arrhythmias. Heart Rhythm. 2020 Sep;17(9):1519-1527. doi: 10.1016/j.hrthm.2020.04.029. Epub 2020 Apr 26.

  PMID: 32348845 RESULT

• Futyma P, Sander J, Ciapala K, Gluszczyk R, Wysokinska A, Futyma M, Kulakowski P. Bipolar radiofrequency ablation delivered from coronary veins and adjacent endocardium for treatment of refractory left ventricular summit arrhythmias. J Interv Card Electrophysiol. 2020 Sep;58(3):307-313. doi: 10.1007/s10840-019-00609-9. Epub 2019 Aug 11.

  PMID: 31402415 RESULT

• Della Bella P, Peretto G, Paglino G, Bisceglia C, Radinovic A, Sala S, Baratto F, Limite LR, Cireddu M, Marzi A, D'Angelo G, Vergara P, Gulletta S, Mazzone P, Frontera A. Bipolar radiofrequency ablation for ventricular tachycardias originating from the interventricular septum: Safety and efficacy in a pilot cohort study. Heart Rhythm. 2020 Dec;17(12):2111-2118. doi: 10.1016/j.hrthm.2020.06.025. Epub 2020 Jun 26.

  PMID: 32599177 RESULT

• Igarashi M, Nogami A, Fukamizu S, Sekiguchi Y, Nitta J, Sakamoto N, Sakamoto Y, Kurosaki K, Takahashi Y, Kimata A, Komatsu Y, Machino T, Kuroki K, Yamasaki H, Aonuma K, Ieda M. Acute and long-term results of bipolar radiofrequency catheter ablation of refractory ventricular arrhythmias of deep intramural origin. Heart Rhythm. 2020 Sep;17(9):1500-1507. doi: 10.1016/j.hrthm.2020.04.028. Epub 2020 Apr 28.

  PMID: 32353585 RESULT

• Kany S, Alken FA, Schleberger R, Baran J, Luik A, Haas A, Ene E, Deneke T, Dinshaw L, Rillig A, Metzner A, Reissmann B, Makimoto H, Reents T, Popa MA, Deisenhofer I, Piotrowski R, Kulakowski P, Kirchhof P, Scherschel K, Meyer C. Bipolar ablation of therapy-refractory ventricular arrhythmias: application of a dedicated approach. Europace. 2022 Jul 15;24(6):959-969. doi: 10.1093/europace/euab304.

  PMID: 34922350 RESULT

• Cronin EM, Bogun FM, Maury P, Peichl P, Chen M, Namboodiri N, Aguinaga L, Leite LR, Al-Khatib SM, Anter E, Berruezo A, Callans DJ, Chung MK, Cuculich P, d'Avila A, Deal BJ, Della Bella P, Deneke T, Dickfeld TM, Hadid C, Haqqani HM, Kay GN, Latchamsetty R, Marchlinski F, Miller JM, Nogami A, Patel AR, Pathak RK, Saenz Morales LC, Santangeli P, Sapp JL Jr, Sarkozy A, Soejima K, Stevenson WG, Tedrow UB, Tzou WS, Varma N, Zeppenfeld K. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias: Executive summary. J Interv Card Electrophysiol. 2020 Oct;59(1):81-133. doi: 10.1007/s10840-019-00664-2.

  PMID: 31960344 RESULT

Study Officials

• Piotr Kulakowski, MD PhD

  Centre for Medical Postgraduate Education

  PRINCIPAL INVESTIGATOR

• Agnieszka Sikorska, MD PhD

  Centre for Medical Postgraduate Education

  STUDY CHAIR

Central Study Contacts

Piotr Kulakowski, MD PhD

CONTACT

604455081; piotr.kulakowskimd@gmail.com

Agnieszka Sikorska, MD PhD

CONTACT

604106455; sikorska.agnieszka.anna@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: February 1, 2023
• Study Start: November 2, 2022
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: from 2023 to 2026
• Access Criteria: individual request from a researcher

Locations

PL (1)