NCT02243891

Brief Summary

The study will test the hypothesis that ablation of paroxysmal atrial fibrillation in hypertensive subjects is more effective when a ROX coupler is inserted concurrently.

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 phase_4 atrial-fibrillation

Timeline
Completed

Started May 2015

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

First Submitted

Initial submission to the registry

September 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

September 16, 2014

Last Update Submit

March 8, 2015

Conditions

Atrial FibrillationHypertension

Outcome Measures

Primary Outcomes (1)

  • AF ablation success

    No AF burden detected on implantable loop recorder

    3 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Atrial fibrillation ablation only

Procedure: Atrial fibrillation ablation

ROX Coupler

EXPERIMENTAL

Atrial fibrillation ablation with concurrent ROX Coupler insertion

Procedure: Atrial fibrillation ablationProcedure: ROX Coupler insertion

Interventions

Atrial fibrillation ablationPROCEDURE

Percutaneous catheter ablation for Atrial fibrillation.

ControlROX Coupler
ROX Coupler insertionPROCEDURE

The ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula

ROX Coupler

Eligibility Criteria

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

You may qualify if:

  • Symptomatic paroxysmal AF suitable for AF ablation.
  • Office Systolic blood pressure ≥ 140 mmHg based on an average of 3 blood pressure readings
  • Ambulatory Blood Pressure Monitoring (ABPM) daytime average systolic blood pressure (SBP) ≥ 135 mmHg;
  • Resistant Hypertension: Patients with established hypertension (diagnosed ≥ 12 months prior to baseline) and is on a guideline based drug regimen at a stable and a fully tolerated dose, consisting of ≥3 hypertensive medications (including 1 diuretic), or
  • Uncontrolled Hypertension: Patient has drug intolerances to antihypertensive medications and is unable to take a guideline based drug regimen
  • VO2 peak \> 15mls/Kg/min on Cardiopulmonary exercise testing (CPX)
  • Peak RER \> 1.0 on Cardiopulmonary exercise testing
  • Age over 18 years old.
  • Informed consent to participate in this study.

You may not qualify if:

  • Secondary hypertension amenable to conventional therapy
  • Left ventricular systolic dysfunction with EF \< 50%
  • E/E' \> 15 on transthoracic echocardiography
  • Uncontrolled diabetes.
  • Body Mass Index \> 40 kg/m2
  • Contraindicated for treatment with an arteriovenous anastomosis or interventional vascular procedure
  • Severe chronic kidney disease as indicated by estimated glomerular filtration rate \< 30 mL/min/1.73m2 using the MDRD calculation
  • Renal denervation within the last 6 months
  • Significant peripheral arterial and/or venous disease in the lower limbs (including unprovoked deep vein thrombosis, significant lower extremity edema and/or venous insufficiency)
  • Current diagnosis of unstable cardiac disease requiring intervention,or significant history of serious cardiac comorbidity that may affect patient safety or study outcomes
  • Current diagnosis of severe cerebrovascular disease or stroke within the past year
  • Female patient who is pregnant, breastfeeding or planning to become pregnant; females of child-bearing potential must have a negative urine pregnancy test prior to treatment
  • Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements
  • Scheduled or planned surgery in the next 6 months that may affect patient safety or study outcomes
  • Concurrent enrollment in another clinical trial without prior approval of ROX Medical, Inc.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastbourne District General Hospital

Eastbourne, East Sussex, BN21 2UD, United Kingdom

Location

MeSH Terms

Conditions

Atrial FibrillationHypertension

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Study Officials

  • Neil Sulke, DM

    East Sussex healthcare NHS trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ragunath Shunmugam, M.B,B.S

CONTACT

+441323417400r.shunmugam@nhs.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Cardiologist

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 18, 2014

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

October 1, 2017

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

GB(1)