Release of Acetylcholine From the Ganglionated Plexus During the Thaw Phase of Cryoballon Pulmonary Vein Ablation (GP RESPONSE Study)

NCT03636100 | Terminated

• 1 other identifier: GP Response
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Determine whether the presence of acetylcholine in the systemic circulation, correlates with the hypotensive response observed during the thaw phase of cryoballoon ablation.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Catheter ablation; Cryoballon ablation; Acetylcholine; Ganglionated plexus; Pulmonary veins; Pulmonary vein isolation

Outcome Measures

Primary Outcomes (1)

• Individual acetylcholine levels

  With each subject serving as their own control, acetylcholine levels between ablation applications will be compared followed by a hypotensive response vs those that are not using paired T-tests.

  1 day

Secondary Outcomes (1)

• Group acetylcholine levels

  1 day

Interventions

Cryoballoon ablation DEVICE

Cryoballoon ablation using standard equipment and techniques

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 14 patients age 18-80 with atrial fibrillation undergoing first time cryoballoon ablation will be enrolled.

You may qualify if:

• patients with atrial fibrillation undergoing first time cryoballoon ablation
• age 18-80

You may not qualify if:

• any prior left atrial ablation or cardiac surgery
• hemoglobin level of \<12.0 g/dL
• refusal or inability to provide informed consent

Sponsors & Collaborators

• Saint Luke's Health System: lead

Study Sites (1)

Saint Luke's Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Related Publications (13)

• Andrade J, Khairy P, Dobrev D, Nattel S. The clinical profile and pathophysiology of atrial fibrillation: relationships among clinical features, epidemiology, and mechanisms. Circ Res. 2014 Apr 25;114(9):1453-68. doi: 10.1161/CIRCRESAHA.114.303211.

  PMID: 24763464 BACKGROUND

• Kojodjojo P, O'Neill MD, Lim PB, Malcolm-Lawes L, Whinnett ZI, Salukhe TV, Linton NW, Lefroy D, Mason A, Wright I, Peters NS, Kanagaratnam P, Davies DW. Pulmonary venous isolation by antral ablation with a large cryoballoon for treatment of paroxysmal and persistent atrial fibrillation: medium-term outcomes and non-randomised comparison with pulmonary venous isolation by radiofrequency ablation. Heart. 2010 Sep;96(17):1379-84. doi: 10.1136/hrt.2009.192419.

  PMID: 20801856 BACKGROUND

• Nakagawa H, Scherlag BJ, Patterson E, Ikeda A, Lockwood D, Jackman WM. Pathophysiologic basis of autonomic ganglionated plexus ablation in patients with atrial fibrillation. Heart Rhythm. 2009 Dec;6(12 Suppl):S26-34. doi: 10.1016/j.hrthm.2009.07.029. Epub 2009 Oct 24.

  PMID: 19959140 BACKGROUND

• Ketels S, Houben R, Van Beeumen K, Tavernier R, Duytschaever M. Incidence, timing, and characteristics of acute changes in heart rate during ongoing circumferential pulmonary vein isolation. Europace. 2008 Dec;10(12):1406-14. doi: 10.1093/europace/eun287. Epub 2008 Oct 19.

  PMID: 18936041 BACKGROUND

• Peyrol M, Barraud J, Koutbi L, Maille B, Trevisan L, Martinez E, Levy S, Paganelli F, Franceschi F. Vagal Reactions during Cryoballoon-Based Pulmonary Vein Isolation: A Clue for Autonomic Nervous System Modulation? Biomed Res Int. 2016;2016:7286074. doi: 10.1155/2016/7286074. Epub 2016 May 3.

  PMID: 27243034 BACKGROUND

• Lemery R. Bradycardia with cooling and cryo: A reminder of the autonomic effects of cold stimuli on the heart. Heart Rhythm. 2016 May;13(5):1018-1019. doi: 10.1016/j.hrthm.2015.12.049. Epub 2016 Jan 6. No abstract available.

  PMID: 26767424 BACKGROUND

• Bordignon S, Furnkranz A, Dugo D, Perrotta L, Gunawardene M, Bode F, Klemt A, Nowak B, Schulte-Hahn B, Schmidt B, Chun KR. Improved lesion formation using the novel 28 mm cryoballoon in atrial fibrillation ablation: analysis of biomarker release. Europace. 2014 Jul;16(7):987-93. doi: 10.1093/europace/eut400. Epub 2014 Jan 19.

  PMID: 24446511 BACKGROUND

• Yanagisawa S, Inden Y, Mizutani Y, Fujii A, Kamikubo Y, Kanzaki Y, Ando M, Funabiki J, Murase Y, Takenaka M, Otake N, Hattori T, Shibata R, Murohara T. Vagal response in cryoballoon ablation of atrial fibrillation and autonomic nervous system: Utility of epicardial adipose tissue location. J Arrhythm. 2017 Aug;33(4):275-282. doi: 10.1016/j.joa.2017.03.001. Epub 2017 Apr 24.

  PMID: 28765757 BACKGROUND

• Kellogg DL Jr, Zhao JL, Coey U, Green JV. Acetylcholine-induced vasodilation is mediated by nitric oxide and prostaglandins in human skin. J Appl Physiol (1985). 2005 Feb;98(2):629-32. doi: 10.1152/japplphysiol.00728.2004.

  PMID: 15649880 BACKGROUND

• Sun L, Dong JZ, DU X, Bai R, Li S, Salim M, Ma CS. Prophylactic Atropine Administration Prevents Vasovagal Response Induced by Cryoballoon Ablation in Patients with Atrial Fibrillation. Pacing Clin Electrophysiol. 2017 May;40(5):551-558. doi: 10.1111/pace.13072. Epub 2017 Apr 25.

  PMID: 28295425 BACKGROUND

• Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.

  PMID: 27381589 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

• Kampaktsis PN, Oikonomou EK, Y Choi D, Cheung JW. Efficacy of ganglionated plexi ablation in addition to pulmonary vein isolation for paroxysmal versus persistent atrial fibrillation: a meta-analysis of randomized controlled clinical trials. J Interv Card Electrophysiol. 2017 Dec;50(3):253-260. doi: 10.1007/s10840-017-0285-z. Epub 2017 Sep 8.

  PMID: 28887742 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: August 15, 2018
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)