CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

NCT ID: NCT01332162

Last Updated: 2016-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2020-12-31

Brief Summary

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The purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.

Detailed Description

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In this study, subjects will be randomized to Cardiac Resynchronization Therapy-Defibrillation (CRT-D) or Cardiac Resynchronization Therapy-Pacing (CRT-P) vs Pacing Therapy AAI. Randomization will be stratified by indication. Optimal pharmacological therapy in both treatment arms. Length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.

Conditions

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Hypertrophic Obstructive Cardiomyopathy (HOCM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biventricular pacing

All patients will be pacing during two years

Group Type EXPERIMENTAL

Biventricular pacing

Intervention Type DEVICE

All patients will be pacing during two years

No Pacing during the first year

No Pacing during the first year. In the second year all patients will be pacing

Group Type ACTIVE_COMPARATOR

No Pacing

Intervention Type DEVICE

No Pacing during the first year. In the second year all patients will be pacing

Interventions

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Biventricular pacing

All patients will be pacing during two years

Intervention Type DEVICE

No Pacing

No Pacing during the first year. In the second year all patients will be pacing

Intervention Type DEVICE

Other Intervention Names

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CRT-D and CRT-P devices: Promote Quadra CD3239-40, CD3239-40Q. St. Jude Medical Promote Q CD3221-36. St. Jude Medical Pacemaquer: Anthem PM3112. St. Jude Medical CRT-D and CRT-P devices: Promote Quadra CD3239-40, CD3239-40Q. St. Jude Medical Promote Q CD3221-36. St. Jude Medical Pacemaquer: Anthem PM3112. St. Jude Medical

Eligibility Criteria

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Inclusion Criteria

* Patients with hypertrophic Obstructive Cardiomyopathy with significant left ventricular obstruction (baseline LVOT gradient more 50mmHg and severe symptoms

Exclusion Criteria

* HOCM intraventricular gradient \< 50mmHg
* LV ejection fraction \< 50%
* mild symptoms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Josep Brugada

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JOSEP BRUGADA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

ANTONIO BERRUEZO, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Dr. Josep Brugada, MD. PhD.

Role: primary

+34932275703

Dr.Antonio Berruezo, MD. PhD.

Role: backup

+34 93 2275551

Other Identifiers

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CRT-01-2011-HCPB

Identifier Type: -

Identifier Source: org_study_id

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