Cryoablation as Standard Treatment of Atrial Flutter

NCT01604369 | Completed DMC

• 1 other identifier: KS1
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the present study is to evaluate cryoablation(cooling of the tissue) as standard therapy of common atrial flutter,focusing on efficacy, feasibility, procedure time, and patient content. The purpose of this study is to determine whether cryoablation, performed only by operators experienced in cryothermic ablation is effective and safe in the treatment of atrial flutter.

Conditions

Atrial Flutter

Keywords

Atrial flutter; Cryoablation; Cavotricuspid isthmus; Visual analogue scale

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Clinical success defined as the freedom from atrial flutter evaluated at the 12-month follow-up.

  One year after intervention

Secondary Outcomes (1)

• Safety

  During and up to one year after intervention

Study Arms (1)

Cryoablation

EXPERIMENTAL

Procedure: Medtronic Freezor Max Cardiac Cryoablation Catheter

Interventions

Medtronic Freezor Max Cardiac Cryoablation Catheter PROCEDURE

Cryoablation is performed using a sequential application technique point-by-point from the tricuspid annulus to the inferior vena cava. Ablation is performed at a target temperature of -80 ºC. Each application will last for 240 seconds.

Also known as: Cryoablation, CTI ablation

Cryoablation

Eligibility Criteria

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

You may qualify if:

• Consecutive patients referred to our institution for ablation therapy of ECG-documented, typical CTI dependent AFL.
• Patients above the age of 18 having symptomatic CTI-dependent AFL documented on a 12-lead ECG with typical ECG appearance of negative saw tooth waves in the inferior limb leads and positive deflections in V1 or positive saw tooth waves in the inferior limb leads and negative deflections in V1.
• Patients with a history of atrial fibrillation will only be included if they have predominant atrial flutter under chronic treatment with class I or III antiarrhythmic agents.

You may not qualify if:

• prior ablation for AFL;
• atrial flutter related to recently undergone surgery, hyperthyroidism or other severe disease;
• inability to adhere with the study protocol;
• pregnancy;
• predominant atrial fibrillation; and
• for patients with persistent atrial flutter contraindication to warfarin

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, SE-14186, Sweden

Location

MeSH Terms

Conditions

Atrial Flutter

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Mats Jensen-Urstad, Professor

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 6, 2016

Record last verified: 2016-10

Locations

SE (1)