NCT02816268

Brief Summary

The investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration 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

September 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

1.7 years

First QC Date

June 24, 2016

Last Update Submit

June 27, 2016

Conditions

Improving Outcome After Pulmonary Vein Isolation

Outcome Measures

Primary Outcomes (1)

  • Number of reconnected pulmonary vein after ablation and a waíting period of 20min

    20min after procedure

Secondary Outcomes (3)

  • Time to first documented recurrence of atrial fibrillation

    12 month

  • Complications due to ablation

    30 days

  • Number of reconnected pulmonary veins

    12 month

Study Arms (2)

Conventional Pulmonary vein isolation

OTHER

Conventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter

Other: Pulmonary vein isolation

Contact force pulmonary vein isolation

OTHER

Contact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®)

Other: Pulmonary vein isolation

Interventions

Pulmonary vein isolationOTHER
Contact force pulmonary vein isolationConventional Pulmonary vein isolation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (\>=18 und \< 80 years) with symptomatic paroxysmal AF
  • At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
  • Oral anticoagulation with phenprocoumone, warfarine or DOAKs for at least 4 weeks prior to ablation with weekly documented INR \> 2..
  • Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.

You may not qualify if:

  • Left atrial thrombus
  • Contraindications for oral anticoagulation or adenosin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München

Munich, 80636, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 28, 2016

Study Start

September 1, 2012

Primary Completion

May 1, 2014

Study Completion

November 1, 2015

Last Updated

June 28, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Locations

DE(1)