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

October 14, 2021 updated by: Saint Luke's Health System

Systemic Release of Acetylcholine From the Autonomic Ganglionated Plexus: a Proposed Mechanism of Induced Hypotension During the Thaw Phase of Cryoballon Pulmonary Vein Ablation (GP RESPONSE Study)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This will be a two-phase (feasibility and primary study phases), prospective observational study with pulmonary vein ablation applications during which a hypotensive response is not observed serving as within-subject controls. A total of 14 patients age 18-80 with atrial fibrillation undergoing first time cryoballoon ablation will be enrolled. Exclusion criteria are any prior left atrial ablation or cardiac surgery, a hemoglobin level of < 12.0 g/dL, or refusal or inability to provide informed consent.

The ablation procedure will be carried out per routine clinical practice by one operator. Two cryoballoon applications targeting 180 seconds per application will be performed per vein. Applications may be abbreviated at the discretion of the operator for indications such as balloon temperatures reaching the mid -50s C, esophageal temperatures approaching 20 C, or a decrease in diaphragmatic movement during phrenic nerve pacing. Application times may be extended to 200 to 240 seconds, also at the discretion of the operator, if within-freeze target temperatures (such as -30 C by 30 seconds or -40 C by 60 seconds) are not met.

A hypotensive response will be defined as a transient ≥ 20% decrease in systolic blood pressure from baseline (start of thaw) during the thaw phase and up to 60 seconds post-end of thaw (balloon deflation). A partial hypotensive response will be defined as a transient 10-19% decrease in systolic blood pressure. For all patients, the time from the end of the cryoballoon freeze to the end of the thaw, to the onset of the hypotensive response, and to blood pressure recovery within 10% of baseline will be recorded. Blood pressure and heart rate will be recorded at each time point. For the first 4 patients (phase I), blood samples of 2-3mL each will be drawn from the mid-right atrium at baseline and then at 30, 60 and 90 seconds after the end of each cryoballoon freeze application. Samples will also be drawn at onset of hypotension and 30 seconds later (superseding the drawing of other samples in the first 90 seconds post-end of freeze), and at blood pressure recovery. Samples will be drawn within 10 seconds of each specified time point; or will not be obtained and will be marked as a missing data point. If more than 20% of the specified data are missing for a given subject, that subject will be excluded from analysis. The samples will then be run on a commercially available 96-well colorimetric assay kit by Cell Biolabs Inc (catalog number STA-603) to assay for acetylcholine.

If the first phase of the study demonstrates the presence of acetylcholine at one or more time points during the thaw phase of 20% or more of cryoballoon applications during which a hypotensive response is observed, the study will proceed to phase 2. The results will be used to determine the optimal time point(s) at which to obtain samples during the second phase of the study (remaining 10 patients), with an anticipated need for 2-4 samples per cryoballoon application, one at start of thaw, another at a determined time point, and when there is a hypotensive response at the onset of hypotension and at blood pressure recovery. An interim report will be produced detailing the observations of phase 1 and specifying the plan for obtaining samples in phase 2.

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Mid America Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual acetylcholine levels
Time Frame: 1 day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Group acetylcholine levels
Time Frame: 1 day
Acetylcholine levels will be compared for the entire study group for applications followed by a hypotensive response vs those that are not. For this analysis each application will be treated as an independent unit and independent T-test will be used to compare acetylcholine levels.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Luke's Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Actual)

October 11, 2019

Study Completion (Actual)

October 11, 2019

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP Response

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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