NCT02074566

Brief Summary

Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.The objective of the study is to assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 active sites

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

February 10, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

August 14, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
Last Updated

March 12, 2020

Status Verified

April 1, 2019

Enrollment Period

3.6 years

First QC Date

February 10, 2014

Last Update Submit

March 10, 2020

Conditions

Atrial Fibrillation

Keywords

Pulmonary Vein IsolationAtrial fibrillationCryoballoon therapyDuration

Outcome Measures

Primary Outcomes (1)

  • Number of patients wit successfull pulmonary vein isolation

    Assessment of successfull pulmonary vein isolation after 2 x 1/2/3 minutes of cryoballoon application. The assessment of this outcome will take place during the procedure.

    up to 6 minutes

Secondary Outcomes (7)

  • Number of complications

    1 year

  • Patients in which acute success of pulmonary vein isolation (after 1 freezing cycle) was present

    up to 6 minutes

  • Duration of thaw phase (= time between end of freezing to automatic deflation of the balloon) related to acute success of pulmonary vein isolation

    up to 6 minutes

  • Procedure time, fluoroscopy time, amount of contrast used

    up to 6 minutes

  • Lower Esophageal Temperature development

    up to 6 minutes

  • +2 more secondary outcomes

Study Arms (3)

2 times 1

OTHER

PVI will be performed using a cryoballoon ablation application time of 2 times 1 minute

Other: Cryoballoon ablation

2 times 2

OTHER

PVI will be performed using a cryoballoon ablation application time of 2 times 2 minutes

Other: Cryoballoon ablation

2 times 3

OTHER

PVI will be performed using a cryoballoon ablation application time of 2 times 3 minutes

Other: Cryoballoon ablation

Interventions

Cryoballoon ablationOTHER

PVI using cryoballoon

2 times 12 times 22 times 3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
  • Age \< 70 years.
  • Willing and able to sign informed consent.
  • Willing to and capable of following the requested study procedures.

You may not qualify if:

  • Age \< 18 years.
  • Pregnancy
  • Life or follow-up expectancy \< 12 months.
  • Previous PVI.
  • Contrast allergy.
  • Creatin clearance level \< 60.
  • Left ventricular ejection fraction \< 40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medisch Spectrum Twente

Enschede, Nederland, 7500 KA, Netherlands

Location

Maastricht University Medical Centre

Maastricht, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Drs.

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 28, 2014

Study Start

August 14, 2014

Primary Completion

March 8, 2018

Study Completion

February 13, 2019

Last Updated

March 12, 2020

Record last verified: 2019-04

Locations

NL(2)