Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation (SUPIR)

September 17, 2018 updated by: Medtronic Cardiac Rhythm and Heart Failure

SUstained PV Isolation With aRctic Front Advance

The purpose of the study is to determine the permanency of PV isolation with the Arctic Front Advance cryoablation system in paroxysmal AF patients. It will also provide data on acute procedural outcomes and measures as well as clinical AF recurrence in these patients approximately 3 months post-ablation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. It is estimated that more than 7 million people worldwide have the disease. Over the past decade, catheter ablation has become an accepted treatment for patients with AF. Ablation strategies that target the pulmonary vein are considered the cornerstone for treatment. The innovative Arctic Front cryoballoon is used for the treatment of drug refractory recurrent symptomatic paroxysmal AF (PAF). The system was designed to overcome many of the challenges of point-by-point catheter ablation by providing an anatomical approach for pulmonary vein isolation (PVI), creating long contiguous circumferential lesions surrounding the pulmonary vein. The cryoballoon system has a low risk of complications and proven efficacy in treating PAF.

AF recurrence rates have been reported up to 30% after initial ablation with PVI technologies including point-by-point RF catheter ablation. Arrhythmia recurrence can be caused by non-contiguous ablation lines that allow conduction gaps. Arctic Front Advance™ Cardiac CryoAblation Catheter (Arctic Front Advance), the second-generation cryoballoon which has recently been introduced following clearance by regulatory agencies in both the US and EU, is positioned to address this challenge with PVI technologies. The new catheter features the EvenCool™ Cryo Technology, which optimizes how the refrigerant is distributed inside the balloon, providing more uniform, distal cooling around the circumference of the balloon. The purpose of this study is to examine the rate of electrical PV isolation with the next generation system .

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

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

  • Czechia
      • Prague, Czechia
        • Homolka Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is at least 18 years old
  • Subject has been diagnosed with recurrent, symptomatic paroxysmal atrial fibrillation, documented as per institutional practice
  • Left atrial diameter is no larger than 5.5cm
  • Subject has failed one or more anti-arrhythmic drugs
  • Subject is indicated for a pulmonary vein ablation using Arctic Front Advance
  • Subject (or subject's legally authorized representative) is able and willing to give informed consent

Exclusion Criteria:

  • Subject has persistent (>7 days) or permanent AF
  • Subject has a left atrial thrombus detected on TEE
  • Subject has had a prior left atrial ablation
  • Subject has an intracardiac thrombus
  • Subject is contraindicated for EP study
  • Subject is unable to tolerate heparin or oral anti-coagulation
  • Subject has a cardiac valve prosthesis
  • Subject has advanced structural heart disease, congenital heart disease (repaired or not), left ventricular ejection fraction (LVEF) <45%, coronary artery bypass graft within 3 months of the procedure
  • Subject has presence of any pulmonary vein stents
  • Subject has presence of any pre-existing pulmonary vein stenosis
  • Subject has had a cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date
  • Subject is a woman known to be pregnant, as documented in medical record
  • Subject is unwilling or unable to comply fully with study procedures and follow-up

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ablation
Ablation with Arctic Front Advance Cardiac CryoAblation system
Device: Arctic Front Advance Cardiac CryoAblation system
Standard of care ablation for indicated paroxysmal AF patients with Medtronic's Arctic Front Advance Cardiac CryoAblation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
electrical pulmonary vein isolation
Time Frame: approximately 3 months postablation
Electrical PV isolation will be determined upon mapping with multielectrode catheter approximately 3 months post-treatment
approximately 3 months postablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical AF recurrence
Time Frame: approximately 3 months post-ablation
ECG-documented clinical AF recurrence will be measured by ambulatory monitoring approximately 3 months post-treatment
approximately 3 months post-ablation

Collaborators and Investigators

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic International Trading Sarl

Investigators

  • Principal Investigator: Vivek Y. Reddy, Nemocnice Na Homolce

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

August 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUPIR001

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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