Changes in Cardiac Autonomic Nervous System Following Atrial Fibrillation Ablation.

NCT03811639 | Completed

• 1 other identifier: 65/PB/2015
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Aim. To compare changes in cardiac autonomic tone caused by radio-frequency versus cryoballoon ablation and to assess their value in predicting the outcome. Study group. In this prospective randomized study 126 consecutive patients with paroxysmal AF undergoing first ablation of AF using radio-frequency (RF) or cryoballoon (CB) technique will be recruited. Patients will undergo several ECG and autonomic tests before and after the procedure. The follow-up will last one year. Measurements:

1. 1.Standard 12-lead ECG a day before and 1-2 days after the procedure will be performed. The SR and P wave duration as well as the difference (∆) in SR and P wave duration before and after ablation will be analyzed.
2. 2.A 24-hour Holter ECG will be performed at baseline (1-2 days before ablation) and 7-day Holter ECG will be performed 3, 6 and 12 months after the procedure. Minimal, maximal and mean heart rate (HR) as well as HRV parameters will be analyzed. The differences (∆) in these variables between baseline and post-ablation Holter ECG recordings will be analyzed.
3. 3.Autonomic parameters (HR, HRV parameters and baroreceptor reflex sensitivity as well as hemodynamic parameters (stroke volume (SV), cardiac output (CO), total peripheral resistance (TPR)) will be also examined before and after orthostatic stress. This will be performed using tilt table test and non-invasive measurement of autonomic and hemodynamic parameters before and shortly after (1-3 days) the procedure.
4. 4.Quality of life will be assessed using the AFSS scale and EHRA scale at baseline and 3, 6 and 12 months after ablation.
5. 5.Follow-up will last 12 months. Efficacy of ablation will be assessed during outpatients visits and using 7-day Holter ECG recordings 3, 6 and 12 months after the procedure. The analyzed outcomes will include symptomatic recurrences of AF, hospitalizations due to AF, redo procedures i occurrence of asymptomatic AF on Holter ECG monitoring.
6. 6.All the above listed parameters and ablation efficacy will be compared between the RF and CB groups.
7. 7.Ablation significantly effects the parameters of cardiac autonomic control
8. 8.These effects are more pronounced in the CB group compared with the RF group
9. 9.Changes in autonomic indices have value in predicting ablation efficacy in both analyzed groups.

Conditions

Atrial Fibrillation

Keywords

ablation, atrial fibrillation, autonomic nervous system

Outcome Measures

Primary Outcomes (3)

• Heart rate-induced changes in the RF and CB groups.

  The baseline and tilt-induced heart rate (beats/min) measured before and after ablation will be compared between the RF and CB groups

  1-2 days before and 2-3 days after ablation heart rate will be recorded

• Heart rate variability (SDNN)-induced changes in the RF and CB groups.

  The baseline and tilt-induced heart rate variability (SDNN) (msec) measured before and after ablation will be compared between the RF and CB groups

  1-2 days before and 2-3 days after ablation SDNN parameter will be recorded

• Baroreflex sensitivity-induced changes in the RF and CB groups.

  The baseline and tilt-induced baroreflex sensitivity (msec/mmHg) measured before and after ablation will be compared between the RF and CB groups

  1-2 days before and 2-3 days after ablation baroreflex sensitivity will be recorded

Secondary Outcomes (4)

• Efficacy of RF versus CB ablation (ECG symptomatic AF recurrences)

  One year

• Ablation-induced changes in heart rate predicting ablation efficacy

  One year

• Ablation-induced changes in heart rate variability predicting ablation efficacy

  One year

• Ablation-induced changes in baroreflex sensitivity predicting ablation efficacy

  One year

Study Arms (2)

RF ablation

ACTIVE COMPARATOR

Patients treated with point-by-point radio-frequency ablation

Procedure: Radio-frequency ablation

Cryoballoon ablation

EXPERIMENTAL

Patients treated with cryoballoon ablation

Procedure: Cryoballoon ablation

Interventions

Radio-frequency ablation PROCEDURE

Ablation for atrial fibrillation

RF ablation

Cryoballoon ablation PROCEDURE

Ablation for atrial fibrillation

Cryoballoon ablation

Eligibility Criteria

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

You may qualify if:

• Paroxysmal AF
• First AF ablation
• Sinus rhythm before and after the procedure at the time of ECG and tilt table testing.
• No change in medication affecting cardiac autonomic nervous system before and after ablation.
• Obtained written informed consent to participate in the study.

You may not qualify if:

• Pacing system implanted
• Additional ablation to PVI like cavo-tricuspid isthmus ablation or linear lesions in the left atrium.

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Department of Cardiology, Postgraduate Medical School, Grochowski Hospital

Warsaw, 04-073, Poland

Location

Related Publications (12)

• Hsieh MH, Chiou CW, Wen ZC, Wu CH, Tai CT, Tsai CF, Ding YA, Chang MS, Chen SA. Alterations of heart rate variability after radiofrequency catheter ablation of focal atrial fibrillation originating from pulmonary veins. Circulation. 1999 Nov 30;100(22):2237-43. doi: 10.1161/01.cir.100.22.2237.

  PMID: 10577997 BACKGROUND

• Pappone C, Santinelli V, Manguso F, Vicedomini G, Gugliotta F, Augello G, Mazzone P, Tortoriello V, Landoni G, Zangrillo A, Lang C, Tomita T, Mesas C, Mastella E, Alfieri O. Pulmonary vein denervation enhances long-term benefit after circumferential ablation for paroxysmal atrial fibrillation. Circulation. 2004 Jan 27;109(3):327-34. doi: 10.1161/01.CIR.0000112641.16340.C7. Epub 2004 Jan 5.

  PMID: 14707026 RESULT

• Yamada T, Yoshida N, Murakami Y, Okada T, Yoshida Y, Muto M, Inden Y, Murohara T. Vagal modification can be a valid predictor of late recurrence of paroxysmal atrial fibrillation independent of the pulmonary vein isolation technique. Circ J. 2009 Sep;73(9):1606-11. doi: 10.1253/circj.cj-09-0158. Epub 2009 Jul 17.

  PMID: 19609042 RESULT

• Yamada T, Yoshida N, Murakami Y, Okada T, Yoshida Y, Muto M, Inden Y, Murohara T. The difference in autonomic denervation and its effect on atrial fibrillation recurrence between the standard segmental and circumferential pulmonary vein isolation techniques. Europace. 2009 Dec;11(12):1612-9. doi: 10.1093/europace/eup330. Epub 2009 Oct 29.

  PMID: 19875397 RESULT

• Yamaguchi Y, Kumagai K, Nakashima H, Saku K. Long-term effects of box isolation on sympathovagal balance in atrial fibrillation. Circ J. 2010 Jun;74(6):1096-103. doi: 10.1253/circj.cj-09-0899. Epub 2010 May 8.

  PMID: 20467150 RESULT

• Oswald H, Klein G, Koenig T, Luesebrink U, Duncker D, Gardiwal A. Cryoballoon pulmonary vein isolation temporarily modulates the intrinsic cardiac autonomic nervous system. J Interv Card Electrophysiol. 2010 Oct;29(1):57-62. doi: 10.1007/s10840-010-9491-7. Epub 2010 Jun 16.

  PMID: 20556498 RESULT

• Lim PB, Malcolme-Lawes LC, Stuber T, Koa-Wing M, Wright IJ, Tillin T, Sutton R, Davies DW, Peters NS, Francis DP, Kanagaratnam P. Feasibility of multiple short, 40-s, intra-procedural ECG recordings to detect immediate changes in heart rate variability during catheter ablation for arrhythmias. J Interv Card Electrophysiol. 2011 Nov;32(2):163-71. doi: 10.1007/s10840-011-9580-2. Epub 2011 Jun 7.

  PMID: 21647641 RESULT

• Wang K, Chang D, Chu Z, Yang Y, Gao L, Zhang S, Xia Y, Dong Y, Yin X, Cong P, Jia J. Denervation as a common mechanism underlying different pulmonary vein isolation strategies for paroxysmal atrial fibrillation: evidenced by heart rate variability after ablation. ScientificWorldJournal. 2013 Aug 24;2013:569564. doi: 10.1155/2013/569564. eCollection 2013.

  PMID: 24058286 RESULT

• Seaborn GE, Todd K, Michael KA, Baranchuk A, Abdollah H, Simpson CS, Akl SG, Redfearn DP. Heart rate variability and procedural outcome in catheter ablation for atrial fibrillation. Ann Noninvasive Electrocardiol. 2014 Jan;19(1):23-33. doi: 10.1111/anec.12098. Epub 2013 Sep 24.

  PMID: 24112475 RESULT

• Kang KW, Kim TH, Park J, Uhm JS, Joung B, Hwang C, Lee MH, Pak HN. Long-term changes in heart rate variability after radiofrequency catheter ablation for atrial fibrillation: 1-year follow-up study with irrigation tip catheter. J Cardiovasc Electrophysiol. 2014 Jul;25(7):693-700. doi: 10.1111/jce.12398. Epub 2014 Mar 28.

  PMID: 24575794 RESULT

• Mori H, Kato R, Ikeda Y, Goto K, Tanaka S, Asano S, Shiki Y, Nagase T, Iwanaga S, Nishimura S, Muramatsu T, Matsumoto K. Analysis of the heart rate variability during cryoballoon ablation of atrial fibrillation. Europace. 2018 Aug 1;20(8):1259-1267. doi: 10.1093/europace/eux225.

  PMID: 29016780 RESULT

• Yu HT, Kim TH, Uhm JS, Kim JY, Joung B, Lee MH, Pak HN. Prognosis of high sinus heart rate after catheter ablation for atrial fibrillation. Europace. 2017 Jul 1;19(7):1132-1139. doi: 10.1093/europace/euw142.

  PMID: 27256421 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Piotr Kulakowski, MD

  Postgraduate Medical School, Grochowski Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of Electrophysiology Department

Model Details: Comparison of changes in autonomic heart regulation caused by radio-frequency ablation and cryoballoon ablation

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: January 22, 2019
• Study Start: October 1, 2015
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: During the study and up to 5 years after study termination
• Access Criteria: Data will be available for researchers who are interested in this field and to reviewers if they ask for data during reviewing process

Locations

PL (1)