NCT01645917

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

July 18, 2012

Last Update Submit

September 17, 2018

Conditions

Paroxysmal Atrial Fibrillation

Keywords

paroxysmal atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • electrical pulmonary vein isolation

    Electrical PV isolation will be determined upon mapping with multielectrode catheter approximately 3 months post-treatment

    approximately 3 months postablation

Secondary Outcomes (1)

  • Clinical AF recurrence

    approximately 3 months post-ablation

Study Arms (1)

Ablation

EXPERIMENTAL

Ablation with Arctic Front Advance Cardiac CryoAblation system

Device: Arctic Front Advance Cardiac CryoAblation system

Interventions

Arctic Front Advance Cardiac CryoAblation systemDEVICE

Standard of care ablation for indicated paroxysmal AF patients with Medtronic's Arctic Front Advance Cardiac CryoAblation system

Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Homolka Hospital

Prague, Czechia

Location

Related Publications (2)

  • Ahmed H, Neuzil P, Skoda J, D'Avila A, Donaldson DM, Laragy MC, Reddy VY. The permanency of pulmonary vein isolation using a balloon cryoablation catheter. J Cardiovasc Electrophysiol. 2010 Jul;21(7):731-7. doi: 10.1111/j.1540-8167.2009.01703.x. Epub 2010 Feb 1.

    PMID: 20132391BACKGROUND

  • Reddy VY, Sediva L, Petru J, Skoda J, Chovanec M, Chitovova Z, Di Stefano P, Rubin E, Dukkipati S, Neuzil P. Durability of Pulmonary Vein Isolation with Cryoballoon Ablation: Results from the Sustained PV Isolation with Arctic Front Advance (SUPIR) Study. J Cardiovasc Electrophysiol. 2015 May;26(5):493-500. doi: 10.1111/jce.12626. Epub 2015 Apr 15.

    PMID: 25644659DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vivek Y. Reddy

    Nemocnice Na Homolce

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 20, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

September 19, 2018

Record last verified: 2018-09

Locations

CZ(1)