NCT00698074

Brief Summary

The primary aim of this study will be to assess whether Biventricular pacing improves exercise capacity, and Quality of Life in patients with symptomatic drug resistant Non-Obstructive Hypertrophic Cardiomyopathy, using a Biventricular pacemaker.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2008

Completed
Last Updated

June 16, 2008

Status Verified

June 1, 2008

First QC Date

June 11, 2008

Last Update Submit

June 13, 2008

Conditions

Study Arms (1)

1

EXPERIMENTAL

Cardiac Resynchronisation Therapy

Device: Cardiac Resynchronisation Therapy

Interventions

Biventricular Pacemaker Implant

1

Eligibility Criteria

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

You may qualify if:

  • Symptomatic Hypertrophic Cardiomyopathy,

You may not qualify if:

  • Rhythm other than normal sinus Left ventricular outflow tract gradient greater than 30mmHg Inability to exercise v02 max greater than 70% of predicted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department Cardiovascular Medicine, University of Birmingham

Birmingham, West Midlands, B15 2TT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Central Study Contacts

Michael P Frenneaux, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 16, 2008

Last Updated

June 16, 2008

Record last verified: 2008-06

Locations