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Renal Denervation Researcher Argues Sham Control Is Ethically Necessary

The lead investigator on the SYMPLICITY HTN-3 trial says sham-controlled trials are sometimes ethically necessary to prevent patients from undergoing ineffective treatments and warns there may be other medical devices on the market that are not as effective as previously thought.

Speaking at the recent Transcatheter Cardiovascular Therapeutics (TCT) Conference, prominent cardiovascular device investigator Deepak Bhatt advised device investigators to listen to the FDA when designing trials, especially when it comes to issues such as use of sham treatments.

Bhatt, a cardiologist at Brigham and Women’s Hospital and lead investigator on the

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