NCT01630330

Brief Summary

There are multiple important factors which need to be monitored when conducting ablation for atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

1.6 years

First QC Date

June 26, 2012

Last Update Submit

June 26, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of Acute Pulmonary Vein Reconnection

    1 hour post procedure

Study Arms (2)

Contact Force Known

ACTIVE COMPARATOR

Ablation with contact force data known

Procedure: Ablation

Contact Force Not Known

EXPERIMENTAL

Contact Force data unavailable during ablation

Procedure: Ablation

Interventions

AblationPROCEDURE

Atrial Fibrillation Ablation with SmartTouch catheter

Contact Force Known

Eligibility Criteria

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

You may qualify if:

  • Patients with symptomatic AF

You may not qualify if:

  • Recent CVA
  • Contraindication to warfarin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton & Harefield Hospital NHS Foundation Trust

London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Shouvik Haldar, MRCP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 28, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations