Hemodynamics Measurement in Radiofrequency Catheter Ablation

NCT04227119 | Completed Results FDA Device

• 1 other identifier: IRB00116832
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

This study will occur in patients undergoing routine cardiac ablation of his/her arrhythmia with planned use of an irrigated ablation catheter. The main objective of this study is to take intracardiac pressure measurements and pressure waveforms with both a "gold standard" balloon tipped pulmonary artery catheter placed for this study and an irrigated ablation catheter placed as standard of care for the procedure.

Conditions

Cardiac Arrhythmia

Keywords

Cardiology; Electrophysiology

Outcome Measures

Primary Outcomes (2)

• Systolic Pressure Value

  The systolic pressure values for atrium and ventricle heart chambers are presented for the irrigated ablation catheter derived measurements and the balloon tipped PA catheter measurements.

  Day 1 (during procedure)

• Diastolic Pressure Value

  The diastolic pressure values for ventricle heart chambers are presented for the irrigated ablation catheter derived measurements and the balloon tipped PA catheter measurements.

  Day 1 (during procedure)

Study Arms (1)

Irrigated ablation catheter and 5F balloon tipped PA catheter

EXPERIMENTAL

Participants undergoing cardiac ablation will have cardiac pressures measured with an irrigated ablation catheter (standard protocol for this procedure) and a 5F balloon tipped pulmonary artery (PA) catheter (for study purposes only).

Device: Irrigated ablation catheter; Device: Balloon tipped PA catheter

Interventions

Irrigated ablation catheter DEVICE

After completion of ablation, the ablation catheter will be serially positioned in the cardiac chambers (either the left or right side of the heart). The stop cock will be turned to the pressure transducer and waveforms will be stored corresponding to each chamber.

Irrigated ablation catheter and 5F balloon tipped PA catheter

Balloon tipped PA catheter DEVICE

After removal of the irrigated ablation catheter, a 5F balloon tipped PA catheter which will be positioned under fluoroscopic guidance in each previously evaluated chamber and the chambers will be measured again.

Irrigated ablation catheter and 5F balloon tipped PA catheter

Eligibility Criteria

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

You may qualify if:

• patient undergoing routine cardiac ablation of his/her arrhythmia with planned use of an irrigated ablation catheter

You may not qualify if:

• inability to provide informed consent

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Anand Shah, MD
• Organization: Emory University

anand.d.shah@emory.edu

404-712-4063

Study Officials

• Anand D Shah, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 13, 2020
• Study Start: January 23, 2020
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)