NCT02217657

Brief Summary

This prospective, randomized study will investigate, if information of the catheter force during ablation of a left anterior line does reduce total RF application time by prevention of ineffective lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 14, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

3.3 years

First QC Date

August 14, 2014

Last Update Submit

February 23, 2021

Conditions

Persistent Atrial Fibrillation

Keywords

Smart-TouchContact force

Outcome Measures

Primary Outcomes (1)

  • Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)

    30 minutes

Secondary Outcomes (1)

  • Achievement of primary endpoint (bidirectional conduction block at an anterior line)

    6 months

Study Arms (2)

operator informed to contact force

ACTIVE COMPARATOR

Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster)

Device: Thermocool Smart Touch Catheter

operator blinded to contact force

EXPERIMENTAL

Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster)

Device: Thermocool Smart Touch Catheter

Interventions

Thermocool Smart Touch CatheterDEVICE

Physician informed to contact force

operator blinded to contact forceoperator informed to contact force

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic atrial fibrillation and additional substrate modification or perimitral flutter
  • Patients with persistent atrial fibrillation
  • Patients with perimitral flutter
  • Patients with recurrence after a circumferential PV isolation procedure
  • Patients with paroxysmal atrial fibrillation and AF episodes lasting \> 7 days
  • Patients (\>18 und \<80 Jahre)

You may not qualify if:

  • moderate to severe valvular heart disease,
  • congenital heart disease
  • reduced left ventricular function (ejection fraction \<35%)
  • any reversible cause for atrial fibrillation (e.g. hyperthyroidism)
  • intracardiac thrombi documented by transesophageal echocardiography
  • myocardial infarction within 3 months, cardiac surgery in the previous three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munich University Clinic, Campus Großhadern

Munich, Bavaria, 81377, Germany

Location

Related Publications (1)

  • Fichtner S, Wakili R, Rizas K, Siebermair J, Sinner MF, Wiktor T, Lackermair K, Schuessler F, Olesch L, Rainer S, Kaab S, Curta A, Kramer H, Estner HL. Benefit of Contact Force Sensing Catheter Technology for Successful Left Atrial Anterior Line Formation: A Prospective Randomized Trial. Biomed Res Int. 2018 Sep 18;2018:9784259. doi: 10.1155/2018/9784259. eCollection 2018.

    PMID: 30320138DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Heidi Estner, MD

    Munich University Clinic, Campus Großhadern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Interventional Electrophysiology

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 15, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)