The Effect of TASH in Patients With HOCM

NCT04066777 | Completed DMC

• 1 other identifier: 1-10-72-62-19
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To examine patients with hypertrophic obstructive cardiomyopathy (HOCM) before and after septal alcohol ablation, to investigate the effect of the treatment in regards to changes in myocardial function, perfusion, invasive hemodynamics and exercise tolerance.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Pulmonary capillary wedge pressure (PCWP) during exercise

  Change in PCWP at 75 watt (or maximum exercise, if this is \< 75 W)

  Changes will be evaluated after an expected average of 6-9 months after treatment

Secondary Outcomes (8)

• Pulmonary capillary wedge pressure (PCWP) at rest

  Changes will be evaluated after an expected average of 6-9 months after treatment

• Peak oxygen uptake (VO2-max)

  Changes will be evaluated after an expected average of 6-9 months after treatment

• Work capacity

  Changes will be evaluated after an expected average of 6-9 months after treatment

• LVOT gradient during maximum exercise

  Changes will be evaluated after an expected average of 6-9 months after treatment

• Coronary flow reserve

  Changes will be evaluated after an expected average of 6-9 months after treatment

Study Arms (1)

Hypertrophic obstructive cardiomyopathy

OTHER

injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction

Procedure: alcohol septal ablation

Interventions

alcohol septal ablation PROCEDURE

injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction

Hypertrophic obstructive cardiomyopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left ventricular wall thickness ≥ 15 mm in one or more myocardial segments that is not explained by loading conditions
• LVOT gradients ≥ 30 mmHg at rest and/or ≥ 50 mmHg at Valsalva's maneuver or exercise
• NYHA ≥ III

You may not qualify if:

• \< 18 years
• Fertile women who do not use anti-contraceptives
• Pregnancy
• Patients are allowed to have a pacemaker (eg. an implantable cardioverter defibrillator (ICD)) but cannot be pace-dependent
• Amiodarone treatment
• Persistent or permanent atrial fibrillation/flutter
• Previous SRT
• Alcohol or drug abuse
• Significant co-morbidity (judged by the investigator)
• Patients who cannot give valid consent (e.g. mental illness or dementia) or who do not understand Danish.

Sponsors & Collaborators

• Steen Hvitfeldt Poulsen: lead

Study Sites (1)

Aarhus University Hospital, Department of Cardiology

Aarhus N, Danmark, 8200, Denmark

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Steen Hvitfeldt Poulsen, DMSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: prospective controlled study

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: May 29, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

DK (1)