RF Lesion Monitoring With 8mm IntellaTip MiFi XP

NCT02089672 | Completed DMC

• 2 other identifiers: IRB00069674ISRCRM90003
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter is introduced into the heart. These catheters can then cauterize abnormally functioning portions of the heart muscle with the hope of returning the heart to a more effective rhythm. In the process of performing such a procedure, called a catheter ablation, an operator must be able to accurately sense electrical activity displayed on computer screens in different parts of the heart, provide sufficient localized energy to the abnormally behaving tissue (ideally without damaging uninvolved heart structures), and accurately reassess the electrical activity of the heart to ensure the spot in the heart has been cauterized. When sensing electrical activity of the heart, specialized catheters produce recordings on a computer screen known as electrograms (EGM). To produce this recording conventional catheters commonly use a positive and negative electrode, from which the difference between the two provides the EGM. The distance between the two electrodes varies from device to device. The greater the distance between them, the less accurate the measurement of local electrical activity becomes. This may result in poorly localized or excessive use of energy that could be damaging to normal heart structures or put the patient at risk for the return or development of additional arrhythmias. The IntellaTip MiFi catheter has been constructed with a specialized sensing tip that uses "microelectrodes" that are relatively close in proximity (\<1 mm apart) with the hope of improving the sensing capability of the device. This study will analyze the signals obtained from this FDA-approved catheter in people undergoing a catheter ablation procedure. The study will examine signals after the procedure is finished and will not prolong or differ the process from a standard ablation procedure. The goal of this study is to determine the ability of the microelectrodes to distinguish ablated, or cauterized versus non-cauterized tissue.

Conditions

Atrial Flutter; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Total bipolar electrogram amplitude using tip to ring and pin to pin configurations

  Acute, averaged one hour during ablation. Measured postoperatively.

Secondary Outcomes (1)

• Total number of seconds per isthmus ablation spent in excess of the post-hoc identified complete lesion time.

  Acute, averaged one hour during ablation. Measured postoperatively

Study Arms (1)

Atrial flutter patients

Atrial flutter patients undergoing catheter ablation

Device: Catheter ablation

Interventions

Catheter ablation DEVICE

This is observational trial studying the effects of a standard intervention of a catheter ablation procedure.

Also known as: 8mm IntellaTip MiFi XP ablation catheter

Atrial flutter patients

Eligibility Criteria

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

Study Population

Enrollment will include 25 patients undergoing a radiofrequency ablation procedure in which ablation of the cavotricuspid isthmus is planned.

You may qualify if:

• Any adult undergoing an atrial flutter ablation

Sponsors & Collaborators

• Emory University: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• Hogh Petersen H, Chen X, Pietersen A, Svendsen JH, Haunso S. Lesion dimensions during temperature-controlled radiofrequency catheter ablation of left ventricular porcine myocardium: impact of ablation site, electrode size, and convective cooling. Circulation. 1999 Jan 19;99(2):319-25. doi: 10.1161/01.cir.99.2.319.

  PMID: 9892601 BACKGROUND

• Sanchez JE, Kay GN, Benser ME, Hall JA, Walcott GP, Smith WM, Ideker RE. Identification of transmural necrosis along a linear catheter ablation lesion during atrial fibrillation and sinus rhythm. J Interv Card Electrophysiol. 2003 Feb;8(1):9-17. doi: 10.1023/a:1022315308803.

  PMID: 12652172 BACKGROUND

Related Links

• Ablation tips with embedded microelectrodes provide enhanced spatial resolution in a canine model.
• Novel Ablation Catheter Technology that Improves Mapping Resolution, and Monitoring of Lesion Maturation

MeSH Terms

Conditions

Atrial Flutter; Arrhythmias, Cardiac

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michael Lloyd, MD FHRS FACC

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 8, 2014
• First Posted: March 18, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (1)