A Comparison of Two Treatments: Pacemaker and Percutaneous Transluminal Septal Ablation for Hypertrophic Cardiomyopathy
NCT ID: NCT00001894
Last Updated: 2006-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
70 participants
INTERVENTIONAL
1999-08-31
2002-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients with HCM who cannot be helped by drug therapy may participate in the study. The standard treatment for such patients is septal myectomy, an operation in which the surgeon shaves the muscle obstructing the blood flow. Another treatment option is implantation of a type of pacemaker that causes the heart to contract in a certain way that reduces blood flow obstruction and improves symptoms. The pacemaker is implanted under local anesthesia and usually takes less than an hour. PTSA is an experimental treatment that may provide a third option. In PTSA, a thin tube (catheter) is inserted into the blood vessel that feeds the heart muscle causing the blood flow obstruction. A small amount of alcohol is injected through the catheter to destroy some of the muscle and relieve the obstruction.
Candidates will have the following screening tests: chest X-ray, electrocardiogram, echocardiogram, exercise tests, exercise radionuclide angiography, exercise thallium scintigraphy, Holter monitoring, cardiac catheterization, electrophysiology study, and coronary angiography. Participants will be assigned to one of the two treatments groups: pacemaker implantation or PTSA. Patients in the PTSA group will also have magnetic resonance imaging scans at the start of the study, 3 to 7 days after PTSA, and at the end of the study, in order to observe changes in the heart's shape. All patients will fill out a questionnaire answering questions about their quality of life.
Patients' progress will be followed with monthly phone calls. In addition, various tests, such as exercise tests and echocardiography, will be done during repeat visits at three and six months to measure treatment results. Patients will again complete quality-of-life questionnaires at both of those visits.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pacemaker implantation
percutaneous transluminal septal ablation (PTSA)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Schulte HD, Bircks WH, Loesse B, Godehardt EA, Schwartzkopff B. Prognosis of patients with hypertrophic obstructive cardiomyopathy after transaortic myectomy. Late results up to twenty-five years. J Thorac Cardiovasc Surg. 1993 Oct;106(4):709-17.
Heric B, Lytle BW, Miller DP, Rosenkranz ER, Lever HM, Cosgrove DM. Surgical management of hypertrophic obstructive cardiomyopathy. Early and late results. J Thorac Cardiovasc Surg. 1995 Jul;110(1):195-206; discussion 206-8. doi: 10.1016/s0022-5223(05)80026-1.
Robbins RC, Stinson EB. Long-term results of left ventricular myotomy and myectomy for obstructive hypertrophic cardiomyopathy. J Thorac Cardiovasc Surg. 1996 Mar;111(3):586-94. doi: 10.1016/s0022-5223(96)70310-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
99-H-0150
Identifier Type: -
Identifier Source: secondary_id
990150
Identifier Type: -
Identifier Source: org_study_id