Completed

DDD Chamber Pacing vs. Percutaneous Transluminal Septal Ablation in Drug-Refractory Obstructive Hypertrophic Cardiomyopathy

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What is being tested

pacemaker implantation

+ percutaneous transluminal septal ablation (PTSA)

Procedure
Who is being recruted

Aortic Valve Disease+5

+ Aortic Stenosis, Subvalvular

+ Aortic Valve Stenosis

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 1999
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: July 4, 2006
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1999

Actual date on which the first participant was enrolled.

Patients with obstructive HCM and drug-refractory symptoms are referred for left ventricular myotomy and myectomy (LVMM) or mitral valve replacement. As alternative therapies to cardiac surgery, we propose to compare the abilities of dual chamber (DDD) pacing and percutaneous transluminal septal ablation (PTSA) to reduce left ventricular (LV) outflow pressure gradients and to improve exercise performance in patients with obstructive HCM and severe symptoms who have failed to benefit from pharmacotherapy.

NCT00001894
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: July 4, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aortic Valve DiseaseAortic Stenosis, SubvalvularAortic Valve StenosisCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesCardiomyopathiesCardiomyopathy, Hypertrophic

Criteria

Patients of either gender, aged 18-80 years. NYHA functional class III/IV, or syncope, or greater than or equal to 2 presyncope despite verapamil and/or Beta-blocker therapy. LV outflow tract gradient greater than or equal to 30 mm Hg at rest or greater than or equal to 50 mm Hg following isoproterenol infusion to a heart rate of greater than 100 bpm. No patients with mid-cavity obstructive HCM. No patients with LV septal wall thickness less than 15 mm estimated by echocardiography. No patients with greater than 50 percent luminal narrowing in a major coronary artery vessel. No patients with chronic atrial fibrillation. No patients with a positive pregnancy test.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps
CompletedOne Study Center