Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Thorax Centrum Twente
Sponsor:
Collaborators:
Thorax Centrum Twente
Academisch Ziekenhuis Maastricht
Information provided by (Responsible Party):
Harald Verheij, Thorax Centrum Twente
ClinicalTrials.gov Identifier:
NCT02074566
First received: February 10, 2014
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Other: Cryoballoon ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicentre Efficacy Study on Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study

Resource links provided by NLM:


Further study details as provided by Thorax Centrum Twente:

Primary Outcome Measures:
  • Number of patients wit successfull pulmonary vein isolation [ Time Frame: up to 6 minutes ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Complications being:

    1. Phrenic nerve palsy or diminishment of diaphragm excursion during cryo-ablation.
    2. Temperatures reaching <12 C in the oesophagus during cryoablation.
    3. Other complications such as delayed gastric emptying, pericardial fluid/tamponade, haemoptoe, vascular complications.

  • Patients in which acute success of pulmonary vein isolation (after 1 freezing cycle) was present [ Time Frame: up to 6 minutes ] [ Designated as safety issue: No ]
    The assessment of this outcome will take place during the procedure

  • Duration of thaw phase (= time between end of freezing to automatic deflation of the balloon) related to acute success of pulmonary vein isolation [ Time Frame: up to 6 minutes ] [ Designated as safety issue: No ]
    The assessment of this outcome will take place during the procedure.

  • Procedure time, fluoroscopy time, amount of contrast used [ Time Frame: up to 6 minutes ] [ Designated as safety issue: No ]
    The assessment of this outcome will take place right after the procedure. It measures procedural parameters.

  • Lower Esophageal Temperature development [ Time Frame: up to 6 minutes ] [ Designated as safety issue: Yes ]
    The measurement will take place during the procedure. It registrates the lower esophageal temperature ande the development during the course of the procedure.

  • Atrial Fibrillation recurrence [ Time Frame: after 1 year follow up ] [ Designated as safety issue: No ]
  • Balloon temperatures measured by the console [ Time Frame: up to 6 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 222
Study Start Date: March 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2 times 1
PVI will be performed using a cryoballoon ablation application time of 2 times 1 minute
Other: Cryoballoon ablation
PVI using cryoballoon
2 times 2
PVI will be performed using a cryoballoon ablation application time of 2 times 2 minutes
Other: Cryoballoon ablation
PVI using cryoballoon
2 times 3
PVI will be performed using a cryoballoon ablation application time of 2 times 3 minutes
Other: Cryoballoon ablation
PVI using cryoballoon

Detailed Description:

Rationale 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.

Objective To assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.

Study design The study is designed as a prospective multicentre randomized efficacy study.

Study population Patients 18-70 years of age with paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.

Intervention Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon ablation after reaching the temperature "plateau phase".

Main study parameters/endpoints Acute success of pulmonary vein isolation.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

No additional risk is present as the procedure is common clinical practice, current cryoballoon application time is 3 minutes Shorter application times are not expected to add to the risk.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paroxysmal atrial fibrillation for which ≥ 1 electrical and/or chemical cardioversions 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.

Exclusion Criteria:

  • Age < 18 years.
  • Pregnancy
  • Life or follow-up expectancy < 12 months.
  • Previous PVI.
  • Contrast allergy.
  • Creatin clearance level < 60.
  • Left ventricular ejection fraction < 40%
  • Abnormal left atrium anatomy defined as number of PV's ≠ 4 or Left Atrium diameter >50mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography). This will lead to exclusion after inclusion but before randomisation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074566

Locations
Netherlands
Medisch Spectrum Twente Not yet recruiting
Enschede, Nederland, Netherlands, 7500 KA
Contact: Department of Cardioresearch    +31534873011    cre@mst.nl   
Maastricht University Medical Centre Not yet recruiting
Maastricht, Netherlands, 6229 HX
Contact: Trang Dinh    +31433877095    trang.dinh@mumc.nl   
Sponsors and Collaborators
Harald Verheij
Thorax Centrum Twente
Academisch Ziekenhuis Maastricht
  More Information

No publications provided

Responsible Party: Harald Verheij, Drs., Thorax Centrum Twente
ClinicalTrials.gov Identifier: NCT02074566     History of Changes
Other Study ID Numbers: NL47337.044.13
Study First Received: February 10, 2014
Last Updated: February 27, 2014
Health Authority: Netherlands: Medische Ethische Toetsingscommissie Twente

Keywords provided by Thorax Centrum Twente:
Pulmonary Vein Isolation
Atrial fibrillation
Cryoballoon therapy
Duration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014